FDA Calendar

2016 Biotech Calendar and beyond for your biotech investing. Biotech Catalyst Calendar. Biotech stocks, FDA Approval/PDUFA, Advisory Committee and Phase 2 & 3 trial data releases dates.

Data are current and updated daily!

IMPORTANT: The BioPharmCatalyst FDA Calendar is NOT an official calendar. It has absolutely NO affiliation with the FDA. The calendar is created using company SEC filings and press releases.

IMPORTANT: Note that the catalyst date is the LATEST expected date for the catalyst to occur by.

For example, if the catalyst date is 12/31/16, this means it is expected to occur BY 12/31/16. It does not necessarily mean that the catalyst will occur ON this date. In most cases it will occur well BEFORE the date.

Please READ the CATALYST NOTES in the RIGHT HAND COLUMN for FULL details and click the link in the right column to access the relevant press release.

Please refer to the “FDA Calendar Glossary” for a list of terms used in the FDA Decision Calendar.

AMEX and NASDAQ companies are listed. Generally no OTC/PINK companies are listed unless the upcoming catalyst is a PDUFA or Advisory Committee event.

LARGE cap companies are generally NOT featured in the database.

TickerPriceMktCapTypeCatalyst Date (due by)Catalyst Notes - click for details
SPPI4.28273.3mNDA filingNDA filing of Apaziquone for bladder cancer due 2015
HRTX18.76606.9mPDUFACompany was informed that the FDA would not be taking action by the PDUFA date of January 17, 2016 and will be extended until late and anticipates taking action in late February 2016. - The NDA is for Sustol for prevention of acute and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
SRPT11.18444.8mAdvisory CommitteeAdvisory Committee Meeting orignially scheduled for January 22 2016 for Eteplirsen in patients with Duchenne muscular dystrophy, has been postponed due to expected snow. New data TBA.
RGLS5.34257.9mPhase 202/15/2016Phase 2 interim data of RG-101 with multiple approved DAAs for the treatment of HCV due mid February 2016. February 15 2016 BPC estimate only. Primary endpoint data due late 2Q 2016
TTNP3.4562.4mPDUFA02/27/2016PDUFA February 27 2016 for Probuphine for Opioid dependence. Advisory Committee Meeting January 22 2016
AAAP24.06870.6mPDUFA priority review02/28/2016PDUFA priority review estimate date February 28 2016 of Somakit-TATE to diagnose somatostatinreceptor-positive NET lesions
FLXN11.24207.4mPhase 302/28/2016Phase 3 data of FX006 for Osteoarthritis of the knee due February 2016
EGRX52.36736.5mPDUFA03/19/2016PDUFA March 19 2016 of RTU bivalirudin liquid for Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)
ACAD18.481.9bAdvisory Committee03/29/2016Psychopharmacologic Drugs Advisory Committee Meeting March 29 2016 for Pimavanserin for the treatment of Parkinson’s disease psychosis (PDP). PDUFA date May 1 2016.
OPK7.763.9bPDUFA03/29/2016PDUFA March 29 2016 of Rayaldy for Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency
CLVS18.56673.3mPDUFA03/30/2016PDUFA March 30 2016 of Rociletinib for mutant EGFR T790M-positive lung cancer. Delay possible due to release of data during review cycle of much lower than expected overall response rates
ACHN5.96754.6mPhase 2a03/31/2016Phase 2a topline SVR data of Odalasvir, simeprevir and ALS-335 for Hepatitis C viral infection (HCV) due 1Q 2016
ALDR20.47808.5mPhase 2b03/31/2016Phase 2b data of ALD403 for Migraine due 1Q 2016
ALDX3.7034.1mPhase 203/31/2016Phase 2 data of NS2 for Allergic conjunctivitis due 1Q 2016
APRI1.1558.8mPhase 2b03/31/2016Phase 2b topline data of Fispemifene for men with symptomatic secondary hypogonadism due 1Q 2016
BMRN65.119.9bPhase 1/203/31/2016Phase 1/2 data of Cerliponase alfa for Batten Disease due 1Q 2016
CLDX6.98648.7mPhase 303/31/2016Phase 3 second interim analysis of CDX-110 rindopepimut - ACT IV for glioblastoma multiforme (GBM) front line due early 2016
CPXX1.2640.3mPhase 303/31/2016Phase 3 overall survival data of CPX-351 for Secondary AML due 1Q 2016
DRRX1.01121.7mNDA filing03/31/2016NDA of Remoxy expected to be refiled 1Q 2016
DVAX18.21625.9mBLA filing03/31/2016BLA filing of HEPLISAV-B for Hepatitis B due by end of 1Q 2016
FOLD5.28568.1m03/31/2016NDA filing of Migalastat HCl monotherapy (012) for Fabry Disease delayed following meeting with FDA. Expect update in 1Q 2016.
GNCA2.8073.2mPhase 203/31/2016Phase 2 12-month data of GEN-003 for Herpes simplex virus type 2 (HSV-2) due 1Q 2016
GWPH40.77853.0mPhase 303/31/2016Top line Phase 3 data of Epidiolex for Dravet Syndrome expected 1Q 2016 (first trial)
LIFE3.9287.9mPhase 1b/203/31/2016Phase 1b/2 data of Resolaris for Adult patients with FSHD due 1Q 2016
MRNS4.4975.9mPhase 203/31/2016Phase 2 data of Ganaxolone for Fragile X Syndrome due 1Q 2016
NBIX32.192.5bPhase 303/31/2016Phase 3 data from second trial of Elagolix for Endometriosis due 1Q 2016
NERV4.71125.7mPhase 2a03/31/2016Phase 2a topline data of MIN-117 for Major Depressive Disorder due 1Q 2016
ONTX0.469.1mPhase 203/31/2016Full data of Oral Rigosertib and azacitidine 09-08 trial for MDS and AML will be acquired 1Q 2016 with Phase 2b to be potentially initiated 2H 2016 subject to financing
PBYI35.501.1bNDA filing03/31/2016NDA filing of PB272 for the extended adjuvant HER2-positive early stage breast cancer due 1Q 2016
PPHM0.88204.2mPhase 303/31/2016Phase 3 SUNRISE interim analysis of Bavituximab for Refractory NSCLC due early 2016. Second analysis due mid 2016. Final data due late 2016
PTIE1.7379.6mNDA filing03/31/2016NDA of Remoxy expected to be refiled 1Q 2016
PTLA29.051.5bPhase 303/31/2016Phase 3 data of Betrixaban (The APEX Study) for the prevention of Venous thromboembolism (VTE) due late 1Q 2016
RARE51.641.9bPhase 203/31/2016Phase 2 interim data of KRN23 for Tumor-induced osteomalacia (TIO) due early 2016. BPC estimate only based on guidance of "early 2016"
RDUS29.221.2bNDA filing03/31/2016NDA filing of Abaloparatide-SC for Osteoporosis due by the end of 1Q 2016
RPTP3.80310.9mPhase 203/31/2016Phase 2 second interim analysis of RP 103 for Mitochondrial disorders including Leigh syndrome due 1Q 2016
RVNC17.12458.1mPhase 203/31/2016Phase 2 trial of RT001 for Hyperhidrosis to be completed 1Q 2016. Larger Phase 2 trial planned for 2016
TNXP3.8173.9mPhase 203/31/2016Phase 2 topline data of TNX-201 for Episodic tension-type headache due 1Q 2016.
TSRO32.061.2bNDA filing03/31/2016NDA filing of Rolapitant - intravenous (IV) for the prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients due 1Q 2016
VCEL1.9545.9mPhase 2b03/31/2016Phase 2b Topline data of ixmyelocel-T in patients with ischemic dilated cardiomyopathy due towards the end of 1Q 2016
ZFGN5.85142.6mPhase 2b03/31/2016Phase 2b data of Beloranib for Severe obesity due 1Q 2016
ZFGN5.85142.6mPhase 303/31/2016Initial data from randomized portion of the Phase 3 trial of Beloranib for Prader-Willi Syndrome (PWS) due 1Q 2016. The company noted in December that a patient was diagnosed with bilateral pulmonary emboli and died in the open label portion of the trial.
INSY15.711.0bPDUFA04/01/2016PDUFA April 1 2016 of Dronabinol Oral Solution for AIDS-related anorexia
ICPT93.892.2bAdvisory Committee04/07/2016PDUFA May 29 2016 of Obeticholic acid (OCA) for Primary biliary cirrhosis (PBC). Advisory Committee meeting April 7 2016.
BLUE45.791.6bPhase 2/304/15/2016Phase 2/3 updated data of Lenti-D for Childhood cerebral adrenoleukodystrophy (CCALD) to be released at AAN Conference April 15-21, 2016
CHMA9.30209.5mPDUFA04/15/2016PDUFA April 15 2016 of Mycapssa for Acromegaly
PGNX3.85252.2mPDUFA04/19/2016PDUFA April 19 2016 of Oral RELISTOR for chronic pain
BMRN65.119.9bPhase 304/30/2016Phase 3 data of PEG-PAL for Phenylketonuria (PKU) due March/April 2016
FLML9.25368.2mPDUFA04/30/2016PDUFA April 30 2016 for Éclat #3
ARQL1.63103.1mPhase 304/30/2016Phase 3 interim analysis of Tivantinib (ARQ 197) METIV-HCC trial for Inoperable Hepatocellular Carcinoma who have been treated with one prior therapy due early 2Q 2016. April 30 estimate only based on company guidance of an "early 2Q" release.
KERX3.19312.9mPhase 304/30/2016Phase 3 data of Auryxia for Iron deficiency anemia in non-dialysis dependent CKD patients due early 2Q 2016. April 30 is a BPC estimate based on "early 2Q" guidance
ACAD18.481.9bPDUFA Priority Review05/01/2016PDUFA date May 1 2016 of Pimavanserin for Parkinson’s disease psychosis (PDP) - under priority review
CTIX1.12131.5mPhase 205/06/2016Phase 2 top line data of Cellceutix for Placque psoriasis due early May 2016. May 6 2016 is a BPC estimate only based on company guidance of "four weeks following early April"
SRPT11.18444.8mPDUFA05/26/2016PDUFA date extended to May 26 2016 of Eteplirsen for Duchenne muscular dystrophy
VNDA7.99317.5mPDUFA05/27/2016PDUFA May 27 2016 for the Supplemental New Drug Application (sNDA) of Fanapt as a maintenance treatment of schizophrenia in adults.
ICPT93.892.2bPDUFA05/29/2016PDUFA May 29 2016 of Obeticholic acid (OCA) for Primary biliary cirrhosis (PBC). Advisory Committee meeting April 7 2016.
ARIA4.61791.7mPhase 2 pivotal06/04/2016Phase 2 pivotal first data of Brigatinib - ALTA trial for Anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) due at ASCO 2016
ADMP4.4155.8mPDUFA06/04/2016PDUFA date June 4, 2016 for the NDA resubmission of Epinephrine Pre-filled Syringe (PFS) for Emergency treatment of anaphylaxis.
EXEL4.24901.9mPDUFA Priority Review06/22/2016PDUFA June 22 2015 under priority review of Cabozantinib for patients with metastatic renal cell cancer (RCC)
LPCN8.20142.3mPDUFA06/28/2016PDUFA June 28 2016 of LPCN 1021 for men with low testosterone (Low T)
ABUS3.00151.7mPhase 206/30/2016Phase 2 data of TKM-PLK1 for Hepatocellular carcinoma (HCC) due 1H 2016
ADRO13.15730.8mPhase 2b 06/30/2016Phase 2b top-line data of CRS-207 and GVAX Pancreas - ECLIPSE trial for Pancreatic cancer to be released 1H 2016
AFMD3.0785.3mPhase 2a06/30/2016Phase 2a interim data due 2Q 2016. Final data due by the end of 2016
AGIO36.341.3bPhase 206/30/2016Phase 2 data of AG-348 for Pyruvate kinase deficiency due 1H 2016
ARGS4.53114.3mPhase 306/30/2016Third interim analysis of Phase 3 AGS-003 ADAPT Trial for mRCC due mid 2016
ARRY2.50322.6mPhase 306/30/2016Phase 3 data of Selumetinib SELECT-1 trial for differentiated thyroid cancer due mid 2016
ARRY2.50322.6mNDA filing06/30/2016NDA filing of Binimetinib (NEMO) for NRAS melanoma expected 1H 2016
ARRY2.50322.6mPhase 306/30/2016Phase 3 data of MEK162 (ARRY-162) - COLUMBUS trial for BRAF mutant melanoma due 1H 2016
BCLI2.1739.1mPhase 206/30/2016Phase 2 data of NurOwn for Amytrophic lateral sclerosis (ALS )due by end of 2Q 2016
BCRX1.8940.2mPhase 206/30/2016Phase 2 data of BCX7353 to reduce or eliminate attacks in HAE patients is expected mid-2016.
BSTC31.32206.5mPhase 206/30/2016Phase 2 topline data of XIAFLEX for Human lipomas due 1H 2016
CANF2.0028.7mPhase 206/30/2016Phase 2 data of CF101 for Glaucoma due 2Q 2016
CARA7.17172.2mPhase 306/30/2016Phase 3 topline data of IV CR845 for Acute pain due 1H 2016
CCXI3.56143.6mPhase 206/30/2016Phase 2 data of CCX168 for atypical Hemolytic Uremic Syndrome (aHUS) due 1H 2016
CCXI3.56143.6mPhase 1b06/30/2016Phase 1b early response data of CCX872 for Non-resectable pancreatic cancer due 1H 2016. Initial PFS data due 2H 2016
CCXI3.56143.6mPhase 206/30/2016Phase 2 top-line data from the CLASSIC trial of CCX168 for Associated vasculitis (AAV) are expected in mid 2016
CEMP16.49663.5mNDA filing06/30/2016Rolling NDA filing of CEM-101 (solithromycin) for CAPB due to be completed 1H 2016
CERU2.0449.9mPhase 206/30/2016Phase 2 data of CRLX101, in combination with Avastin for Relapsed Renal Cell Carcinoma due 1H 2016
CHRS12.71432.6mPhase 306/30/2016Phase 3 data of CHS-1420 for Psoriasis due 1H 2016
CLVS18.56673.3mNDA filing06/30/2016NDA filing for rucaparib for second line ovarian cancer planned for 2Q 2016
CORT3.50386.3mPhase 1/206/30/2016Phase 1/2 data of mifepristone in combination with eribulin for triple-negative breast cancer due mid 2016
CYCC0.3310.0mPhase 306/30/2016Phase 3 top-line data of Sapacitabine (SEAMLESS) trial for Acute myeloid leukemia due by end of 2Q 2016. Company noted mid-Dec 2014 that interim analysis suggests that trial will fail.
CYTR1.74114.4mPhase 306/30/2016Phase 3 PFS data of aldoxorubicin with doxorubicin for refractory soft tissue sarcomas due 1H 2016
DERM24.31666.6mPhase 206/30/2016Phase 2b data of DRM01 for Acne due 2Q 2016
DERM24.31666.6mPhase 306/30/2016Phase 3 data of DRM04 for Primary axillary hyperhidrosis due mid 2016.
DNAI6.75188.8mPhase 206/30/2016Phase 2 initial data of PNT2258 for Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) due 2Q 2016
EARS4.21150.3mPhase 306/30/2016Phase 3 topline data of AM-101 for Acute inner ear tinnitus due 2Q 2016
ESPR14.31292.4mPhase 206/30/2016Phase 2 (PK/PD) top-line data of ETC-1002 in combination with high-dose statins (HDS) due mid 2016
EXEL4.24901.9mPhase 206/30/2016Phase 2 data of Cabozantinib - CABOSUN trial for First-Line RCC due 1H 2016
FCSC2.1790.7mPhase 206/30/2016Phase 2 data of azficel-T for Chronic Dysphonia due 2Q 2016
GNCA2.8073.2mPhase 2b06/30/2016Phase 2b top-line viral shedding data of GEN-003 for the treatment of genital herpes are due mid-2016 and clinical efficacy data against potential Phase 3 study endpoints at six months after dosing in 2H 2016.
GWPH40.77853.0mPhase 306/30/2016Top line Phase 3 data of Epidiolex for Dravet Syndrome expected mid 2016 (second trial)
GWPH40.77853.0mPhase 2b06/30/2016Phase 2 data of GWP42004 for Type 2 diabetes mid-2016
GWPH40.77853.0mPhase 306/30/2016First Phase 3 trial data of Epidiolex for Lennox-Gastaut syndrome (LGS) due 2Q 2016
GWPH40.77853.0mPhase 206/30/2016Phase 2 data of Sativex for Multiple Sclerosis (MS) spasticity due mid 2016
HRTX18.76606.9mPhase 206/30/2016Phase 2 data of HTX-011 for Bunionectomy due 1H 2016
INNL8.22199.5mPhase 306/30/2016Phase 3 data of XaraColl for Post-operative pain due 2Q 2016
IRWD7.971.1bPhase 2a06/30/2016Phase 2a data of IW-9179 for Gastroparesis due 1H 2016
KMDA3.63138.0mBLA filing06/30/2016BLA filing of KamRAB for Prophylaxis of rabies disease due mid 2016
KMDA3.63138.0mPhase 206/30/2016Phase 2 top-line data of Inhaled formulation of AAT for AATD - Alpha-1 Antitrypsin deficiency due mid 2016
KPTI5.80196.1mPhase 206/30/2016Phase 2 initial data of Selinexor SOPRA trial for Relapsed/Refractory Acute Myeloid Leukemia (AML) due mid 2016. Preliminary topline data due 4Q 2016.
KPTI5.80196.1mPhase 206/30/2016Phase 2 interim data of Selinexor - STORM trial for Quadruple Refractory Multiple Myeloma due mid 2016
MCRB22.31808.5mPhase 206/30/2016Phase 2 data of SER-109 for Recurrent C. Difficile infection due mid 2016
MRNS4.4975.9mPhase 206/30/2016Phase 2 data of Ganaxolone for Female children with Epilepsy due mid 2016
MRNS4.4975.9mPhase 306/30/2016Phase 3 top-line data of Ganaxolone for Epilepsy due mid 2016
MSTX0.4271.8mPhase 306/30/2016Phase 3 top-line data of ANX-188 for Sickle cell disease (EPIC trial) due 2Q 2016
NERV4.71125.7mPhase 2b06/30/2016Phase 2b European data of MIN-101 for Schizophrenia due 2Q 2016
OCAT8.47358.3mPhase 206/30/2016Phase 2 Interim top-line results from the first cohort of Retinal pigment epithelium cells for Age-related macular degeneration due 2Q 2016 and the interim read-out on the second two cohorts is expected due by the end of 2016
PBYI35.501.1bPhase 206/30/2016Phase 2 trial of PB272 for HER2+ MBC that has metastasized to the brain to be completed 1H 2016
PRTA30.94966.8mPhase 1/206/30/2016Phase 1/2 data of NEOD001 for AL amyloidosis and persistent organ dysfunction expected 2Q 2016
PRTK12.78221.1mPhase 306/30/2016Phase 3 topline data of Omadacycline for Acute bacterial skin and skin structure infections (ABSSSI) due mid 2016
PSDV3.0496.8mNDA Filing06/30/2016NDA filing of Medidur for Posterior uveitis planned for 1H 2016
RARE51.641.9bPhase 306/30/2016Phase 3 data of rhGUS for Mucopolysaccharidosis 7 (MPS 7) due mid 2016.
RARE51.641.9bPhase 206/30/2016Phase 2 data of UX007 (triheptanoin) for Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS) due 1H 2016
RIGL2.36199.8mPhase 306/30/2016Phase 3 initiated July 2014. Data from the first of two trials due mid 2016 with the second shortly after
RGLS5.34257.9mPhase 206/30/2016Phase 2 Primary endpoint data due late 2Q 2016 of RG-101 with multiple approved DAAs for the treatment of HCV
RPRX0.9219.5mPhase 2b06/30/2016Phase 2b data of Proellex for Uterine fibroids (vaginal treatment) due 2Q 2016
RVNC17.12458.1mPhase 306/30/2016Phase 3 interim data of RT001 for Lateral Canthal (Crow’s Feet) Lines due 1H 2016
RVNC17.12458.1mPhase 206/30/2016Phase 2 final data of RT002 for Moderate to severe glabellar (frown) lines to be released 1H 2016.
RVNC17.12458.1mPhase 206/30/2016Phase 2 interim data of RT002 for Cervical dystonia due 1H 2016
SCYX4.6764.4mPhase 206/30/2016Phase 2 topline data of SCY-078 for serious and life-threatening invasive fungal infections due 1H 2016
SCYX4.6764.4mPhase 206/30/2016Phase 2 topline data of SCY-078 for Ulvovaginal candidiasis due 1H 2016
SGYP3.31347.9mPhase 306/30/2016Phase 3 data of Plecanatide for Constipation-predominant irritable bowel syndrome (IBS-C) due 1H and 2H 2016
SYN1.1093.8mPhase 2a06/30/2016Topline results from the second Phase 2a trial of SYN-004 in patients with C. difficile Infection due 1H 2016
TBRA6.5571.9mPhase 2a07/01/2016Phase 2a interim analysis of Cenicriviroc (CVC) - ORION study in obese subjects with prediabetes or Type 2 diabetes mellitus and suspected NALFD, due 2Q 2016
TCON6.4574.0mPhase 206/30/2016Phase 2 data of TRC105 for Soft tissue sarcomas due 1H 2016
THLD0.2820.6mPhase 206/30/2016Phase 2 prelim data of Tarloxotinib for Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck or Skin due 1H 2016
THLD0.2820.6mPhase 206/30/2016Phase 2 preliminary data of Tarloxotinib for mutant EGFR-positive, T790M-negative advanced non-small cell lung cancer due 1H 2016
TNXP3.8173.9mPhase 206/30/2016Phase 2 data of TNX-102 SL for PTSD - for the treatment of post-traumatic stress disorder due 2Q 2016
TRVN7.44374.4mPhase 2b06/30/2016Phase 2b data of TRV027 (BLAST-AHF) trial for Acute heart failure due 2Q 2016
TSRO32.061.2bPhase 306/30/2016Phase 3 top-line data of Niraparib - NOVA for ovarian cancer due 2Q 2016.
TSRO32.061.2bPhase 206/30/2016Phase 2 data of Niraparib - (QUADRA trial) for ovarian cancer due 2Q 2016
VRTX80.1418.6bNDA Filing06/30/2016sNDA filing of ORKAMBI for children with CF aged 6-11 with two copies of the F508del mutation due 2Q 2016
VTVT5.84186.1mPhase 206/30/2016Phase 2 results of TTP399 - AGATA for the treatment of Type 2 Diabetes due mid-2016
OCUL5.54128.3mPDUFA07/24/2016PDUFA July 24 2016 of DEXTENZA for Ocular inflammation and pain following cataract surgery
ADMA4.4443.0mPDUFA07/31/2016PDUFA date on or about July 31 2016 for RI-002 for primary Immune Deficiency Diseases
INFI5.60264.6mPhase 207/31/2016Phase 2 data of Duvelisib (IPI-145) for Indolent non-Hodgkin lymphoma due early 3Q 2015. July 31 BPC estimate only based on company guidance of data due EARLY 3Q 2015
ENTA23.16413.7mPDUFAPDUFA 2H 2016 for VIEKIRA PAK - once-daily, fixed-dose formulation for HCV - genotype - through Abbvie
ABUS3.00151.7mPhase 209/30/2016Phase 2 HBsAg reduction results from single dose of ARB-1467 (TKM-HBV, RNAi) for Hepatitis B virus infection (HBV) due 3Q 2016, multiple dose data due 4Q 2016
AUPH2.4483.6mPhase 2b09/30/2016Phase 2b data of Voclosporin for Lupus due 3Q 2016
AERI13.80328.9mNDA filing09/30/2016NDA filing of Rhopressa for Glaucoma due 3Q 2016
CLCD5.2075.0mPhase 309/30/2016Phase 3 Top-line data of Lasmiditan - SAMURAI trial for Migraine available 3Q 2016.
CYTX0.1417.3mPhase 209/30/2016Phase 2 full data of ECCO-50 cellular therapeutic for Osteoarthritis of the knee due 3Q 2016. Noted in February 2016 that interim data showed the pre-specified primary endpoint did not obtain statistical significance.
INNL8.22199.5mPhase 309/30/2016Phase 3 data of Cogenzia for Diabetic foot ulcer infections due 3Q 2016
NVAX4.621.2bPhase 309/30/2016Phase 3 data of RSV F Vaccine - Resolve trial for the prevention of moderate-severe RSV-associated lower respiratory tract disease due 3Q 2016
OGXI0.6417.5mPhase 309/30/2016Phase 3 final data of Custirsen in combination with Jevtana (cabazitaxel) - AFFINITY trial for castrate-resistant prostate second-line cancer due 3Q 2016 but have already noted that a subpopulation who had multiple poor prognostic risk factors did NOT show improvement in survival
PRQR3.9465.3mPhase 1b/209/30/2016Phase 1b data of QR-010 for Cystic Fibrosis due mid-late 2016
PTN0.5333.3mPhase 309/30/2016Phase 3 top-line data of Bremelanotide for female sexual dysfunction (FSD) due 3Q 2016
RPRX0.9219.5mPhase 209/30/2016Phase 2 data of Proellex for Endometriosis due 3Q 2016
TBRA6.5571.9mPhase 2b09/30/2016Phase 2b data of Cenicriviroc (CVC) - CENTAUR study for Non-alcoholic Steatohepatitis (NASH) due 3Q 2016
TNXP3.8173.9mPhase 309/30/2016Phase 3 data of TNX-102 SL for Fibromyalgia due 3Q 2016
VICL0.3431.1mPhase 209/30/2016Phase 2 data of ASP0113 Vaccine for Kidney transplant recipients due 3Q 2016
VSAR8.58235.2mPhase 209/30/2016Phase 2 data of VRS-317 VITAL trial for Growth hormone deficiency, or GHD in adults due 3Q 2016
BLUE45.791.6bPhase 1/212/03/2016Phase 1/2 trial updated data of LentiGlobin for β-Thalassemia expected at ASH December 2016
BLUE45.791.6bPhase 1/212/03/2016Phase 1/2 trial updated data of LentiGlobin for Sickle disease expected at ASH December 2016
ACOR35.351.5bPhase 312/31/2016Phase 3 interim data of Dalfampridine for Post stroke deficits due 2016
ACOR35.351.5bPhase 312/31/2016Phase 3 data of CVT-301 for OFF episodes of Parkinson’s disease (PD) due 2016
ACRX3.47147.2mNDA filing12/31/2016NDA of ARX-04 for Moderate-to-severe acute pain to be filed 2H 2016
ADMS13.50264.4mPhase 212/31/2016Phase 2 data of ADS-5102 for Multiple sclerosis (MS) due 2016
ADRO13.15730.8mPhase 2b 12/31/2016Phase 2b interim data of CRS-207 and GVAX Pancreas and nivolumab - STELLAR trial for Pancreatic cancer to be released 2H 2016
AEZS2.9428.2mPhase 312/31/2016Phase 3 trial of Zoptrex for castration and taxane resistant prostate cancer to be completed 2H 2016
AEZS2.9428.2mPhase 312/31/2016Phase 3 completion of Macrilen for Adult Growth Deficiency expected to be completed by end of 2016.
AFMD3.0785.3mPhase 2a12/31/2016Phase 2a interim data due 2Q 2016. Final data due by the end of 2016
ANTH2.7199.6mPhase 312/31/2016Phase 3 final data of Blisibimod for Lupus due 2H 2016.
APRI1.1558.8mNDA filing12/31/2016NDA filing of Vitaros for Erectile dysfunction to be resubmitted 2H 2016
ARDX9.16293.5mPhase 2b12/31/2016Phase 2b data of Tenapanor for CKD patients with hyperphosphatemia on dialysis due 2H 2016
ARIA4.61791.7mPhase 212/31/2016Phase 2 dose ranging trial preliminary data of Iclusig (ponatinib) for third line chronic-phase CML (CP-CML) due end of 2016
BLPH2.8436.3mPhase 212/31/2016Phase 2 data of INOpulse delivery device for Pulmonary Hypertension associated with COPD (PH-COPD) due by end of 2016
BLPH2.8436.3mPhase 212/31/2016Phase 2 data of INOpulse delivery device for Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF) due by end of 2016
BOTA1.2847.5mPhase 2b12/31/2016Phase 2b top-line data of Vapendavir for Human rhinovirus (HRV) due 2H 2016
CERC2.9826.2mPhase 212/31/2016Phase 2 data of CERC-501 for Smoking cessation due 2H 2016
CYTR1.74114.4mPhase 2b12/31/2016Phase 2b data of Aldoxorubicin for relapsed/refractory small cell lung cancer due 2H 2016
DPRX7.0967.8mPhase 312/31/2016Phase 3 trials of Locilex for Mild infections of diabetic foot ulcers, due to be completed 2H 2016
FOLD5.28568.1mPhase 212/31/2016Phase 2 interim and final data of ATB200 for Pompe Disease due 2016
FOLD5.28568.1mPhase 312/31/2016Phase 3 top-line data of SD-101 for Epidermolysis Bullosa (EB) due 2H 2016
GALE0.67124.4mPhase 2b12/31/2016Phase 2a two-year data of GALE-301 for ovarian cancer due 4Q 2016
GALE0.67124.4mPhase 2b12/31/2016Phase 2b interim safety data and patient immunology data on the A24 and A25 Human Leukocyte Antigen (HLA) status due 4Q 2016 for NeuVax in combination with Herceptin for breast cancer
GBIM1.9911.4mPhase 212/31/2016Phase 2 48-week results of GS-4774 - 0101 trial - for chronic hepatitis B infection are expected to be available 2H 2016
GBIM1.9911.4mPhase 212/31/2016Phase 2 data of GI-6207 for MTC (medullary thyroid cancer) due 2H 2016
GLMD5.1051.2mPhase 2b12/31/2016Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 2H 2016. Final Data due 2Q 2017
GTXI0.7097.7mPhase 212/31/2016Phase 2 top-line data of Enobosarm for Postmenopausal women with stress urinary incontinence (SUI) are due 2016
GWPH40.77853.0mPhase 212/31/2016Phase 2 data of GWP42006 for Epilepsy due 2H 2016
HALO7.28863.5mPhase 212/31/2016Phase 2 PFS data of PEGPH20 for pancreatic cancer due 4Q 2016
HRTX18.76606.9mNDA filing12/31/2016NDA filing of HTX-019 for the prevention of chemotherapy-induced nausea and vomiting (CINV) due 2H 2016
HTBX2.0616.5mPhase 212/31/2016Phase 2 data of HS-410 for bladder cancer due 4Q 2016
HTBX2.0616.5mPhase 1b12/31/2016Phase 1b topline data of HS-110 for NSCLC non-small cell lung cancer due 4Q 2016
HZNP16.202.6bPhase 312/31/2016Phase 3 data of ACTIMMUNE for Friedreich's Ataxia (FA) due by the end of 2016
IDRA1.68181.0mPhase 1/212/31/2016Phase 1/2 data of IMO-8400 for patients with DLBCL who harbor the MYD88 L265P mutation due 2016
IMGN7.13578.5mPhase 312/31/2016Phase 3 data of Kadcyla - KRISTINE trial - for patiets with HER2-positive breast cancer - neo-adjuvant setting, due 2016
INCY72.2613.4bPhase 312/31/2016Phase 3 data from of Ruxolitinib - JANUS 1 trial for pancreatic cancer due 2016
INCY72.2613.4bPhase 212/31/2016Phase 2 data of Ruxolitinib for Breast Cancer due 2016
INCY72.2613.4bPhase 212/31/2016Phase 2 data of Ruxolitinib for Colorectal cancer due 2016
INFI5.60264.6mPhase 312/31/2016Phase 3 interim analysis of Duvelisib - DUO trial for relapsed/refractory chronic lymphocytic leukemia (CLL) due 2H 2016
INFI5.60264.6mPhase 1b/212/31/2016Phase 1/2 initial data of Duvelisib - Conetempo trial for treatment-naïve patients with follicular lymphoma due 2H 2016
ITEK6.38159.7mPhase 312/31/2016Phase 3 top-line data of Rabodenoson for Primary open-angle glaucoma (POAG) due 4Q 2016
KPTI5.80196.1mPhase 2b12/31/2016Phase 2b preliminary topline data of Selinexor - SADAL trial for Diffuse Large B-Cell Lymphoma (DLBCL) due 4Q 2016.
LJPC14.06229.9mPhase 312/31/2016Phase 3 data of LJPC-501 for Catecholamine-resistant hypotension (CRH) due by end of 2016
LXRX8.02774.9mPhase 312/31/2016Phase 3 data of Sotagliflozin for Type 1 Diabetes due 2H 2016
NBIX32.192.5bNDA Filing12/31/2016NDA filing of NBI-98854 for Tardive dyskinesia due 2016
NBIX32.192.5bPhase 212/31/2016Phase 2 data of NBI-98854 (Valbenazine) for Tourette syndrome due by end of 2016
NKTR11.341.4bPhase 312/31/2016Bayer Phase 3 program called RESPIRE of Cipro DPI (Cipro Dry Powder Inhaler) for Non-cystic fibrosis bronchiectasis. Data due 2H 2016
NLNK20.57531.7mPhase 312/31/2016Phase 3 data of HyperAcute Pancreas - IMPRESS trial for Surgically resected pancreatic cancer due 2016
NVLS4.4763.0mPhase 212/31/2016Phase 2 data of N91115 for Cystic Fibrosis due 2H 2016
OCRX2.6147.8mPhase 2b12/31/2016Phase 2b trial of OCR-002 for Hepatic encephalopathy to be completed 2H 2016
OGXI0.6417.5mPhase 212/31/2016Phase 2 data of OGX-427 Borealis-2 trial for advanced or metastatic bladder cancer due 2H 2016
OPHT46.341.5bPhase 312/31/2016Phase 3 initial topline data of Fovista for Wet-AMD due 4Q 2016
OPK7.763.9bPhase 312/31/2016Phase 3 data of hGH-CTP in adults with growth hormone deficiency likely due 2H 2016
OPXA1.8612.2mPhase 2b12/31/2016Phase 2b top-line data of Tovaxin (Tcelna) for Secondary Progressive MS (SPMS) due 2H 2016.
OXGN0.5413.2mPhase 1b/212/31/2016Phase 1b/2 data of OXi4503 for Acute myeloid leukemia (AML) due 2016
OXGN0.5413.2mPhase 212/31/2016Phase 2 full data of Fosbretabulin for gastrointestinal neuroendocrine tumors due 2H 2016
PPHM0.88204.2mPhase 212/31/2016Phase 2 initial data of Bavituximab and Durvalumab for both NSCLC and breast cancer trials may be available in late 2016 or early 2017
PRTK12.78221.1mPhase 312/31/2016Phase 3 data of Sarecycline for Severe acne vulgaris due 2016
PRTO7.30111.4mPhase 312/31/2016Phase 3 data of PRT-201 for Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) due December 2016
PTCT23.76772.6mPhase 312/31/2016Phase 3 data of Ataluren for Nonsense mutation cystic fibrosis due around the end of 2016
RARE51.641.9bPhase 212/31/2016Phase 2 data of Triheptanoin for Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) due 2H 2016.
REPH6.6358.6mPhase 312/31/2016Phase 3 top-line data of Intravenous (IV) meloxicam for patients with Acute pain following bunionectomy surgery due by end of 2016 - two Phase 3 trials
RIGL2.36199.8mPhase 212/31/2016Phase 2 data of R348 for Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD) due 2016
RIGL2.36199.8mPhase 212/31/2016Phase 2 data of Fostamatinib for IgA nephropathy due by the end of 2016
SAGE30.04874.5mPhase 312/31/2016Phase 3 data of SAGE-547 for SRSE due 2H 2016
SGEN29.043.7bPhase 312/31/2016Phase 3 data from ALCANZA trial of ADCETRIS for relapsed CD30-positive cutaneous T-cell lymphoma due 2H 2016
SGEN29.043.7bPhase 212/31/2016Phase 2 data of ADCETRIS for Diffuse Large B-cell Lymphoma (DLBCL) are due in 2016
SNGX0.8523.1mPhase 312/31/2016Phase 3 results of SGX301 (synthetic hypericin) for Cutaneous T-Cell Lymphoma (CTCL) due 2H 2016
STEM0.3234.0mPhase 212/31/2016Phase 2 trial of HuCNS-SC cells for Spinal cord injury to be completed in 2016
TBPH16.32602.7mPhase 2a12/31/2016Phase 2a data of TD-6450 for Hepatitis C virus (HCV) due 2016
TBPH16.32602.7mPhase 312/31/2016Phase 3 data of Revefenacin for COPD due 2016
TBPH16.32602.7mPhase 312/31/2016Phase 3 data of TD-4208 for Chronic obstructive pulmonary disease (COPD) due in 2016
TCON6.4574.0mPhase 212/31/2016Phase 2 data of TRC105 for Renal Cell Carcinoma due late 2016
TCON6.4574.0mPhase 212/31/2016Phase 2 data of TRC105 and Temodar for Glioblastoma due 2016
TENX2.3861.8mPhase 312/31/2016Phase 3 top line data of Levosimendan to reduce the incidence of low cardiac output syndrome during cardiac surgery due by end of 2016
TGTX8.18408.4mPhase 312/31/2016Phase 3 data of TG-1101 and IMBRUVICA (GENUINE trial) for Chronic Lymphocytic Leukemia (CLL) due 2H 2016
VBLT3.1568.0mPhase 312/31/2016Phase 3 interim data of VB-111 for recurrent glioblastoma, or rGBMdue 2H 2016
VRTX80.1418.6bPhase 312/31/2016Phase 3 interim analysis of VX-661 for Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in minimal CFTR Function, due by the end of 2016
VSAR8.58235.2mPhase 312/31/2016Phase 3 interim 6 month height velocity analysis of VRS-317 for Growth hormone deficiency in pediatric patients are due by end of 2016 and top line data on the 12 month height velocity primary endpoint is expected in mid 2017.
VTAE8.32166.9mPhase 212/31/2016Phase 2 topline data of VTP-38543 for Atopic dermatitis due 2H 2016
VTVT5.84186.1mPhase 212/31/2016Phase 2 topline results for TTP273 - LOGRA trial for Type 2 Diabetes are expected at the end of 2016.
VYGR10.39271.2mPhase 1b12/31/2016Phase 1b data of VY-AADC01 for Parkinson's Disease due 2H 2016
XENE7.00100.3mPhase 2b12/31/2016Phase 2b data of TV-45070 for Postherpetic neuralgia due 2H 2016
CAPR2.5035.8mPhase 203/31/2017Phase 2 six month data of CAP-1002 ALLSTAR trial for Myocardial infarction (heart attack) due 1Q 2017
CAPR2.5035.8mPhase 1/203/31/2017Phase 1/2 data of CAP-1002 HOPE-Duchenne trial for Duchenne Muscular Dystrophy (DMD) due 1Q 2017
DERM24.31666.6mPhase 303/31/2017Phase 3 data of Cimzia for Moderate-to-severe plaque psoriasis due by end of 1Q 2017
DSCO2.4320.0mPhase 2b03/31/2017Phase 2b top-line data of Aerosurf for Respiratory Distress Syndrome due 1Q 2017.
KPTI5.80196.1mPhase 2/303/31/2017Data from Phase 2 portion of Phase 2/3 trial of Selinexor - SEAL trial in patients with dedifferentiated liposarcoma due early 2017
VRTX80.1418.6bPhase 303/31/2017Phase 3 data of VX-661 in patients with two Copies of the F508del Mutation are expected by early 2017.
ABIO3.4531.9mPhase 2b06/30/2017Phase 2b interim analysis of Gencaro - GENETIC-AF trial for Chronic Heart Failure due 1H 2017
ALNY59.224.6bPhase 306/30/2017Phase 3 data due of Patisiran APOLLO trial for Familial Amyloidotic Polyneuropathy (FAP) in patients with ATTR due in 2017, with NDA to be filed late 2017 assuming positive data. BPC estimate mid 2017 for data release
FLML9.25368.2mPhase 306/30/2017Phase 3 trial of Micropump Sodium Oxybate for Narcolepsy expected to be completed mid 2017
GLMD5.1051.2mPhase 2b06/30/2017Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 2H 2016. Final Data due 2Q 2017
MACK5.44564.2mPhase 206/30/2017Phase 2 data of ONIVYDE for first line pancreatic due 1H 2017
MDWD6.63138.5mPhase 306/30/2017Phase 3 topline data of NexoBrid for Severe burns due 1H 2017
MNOV4.18125.8mPhase 2b06/30/2017Phase 2b data of MN-166 for Progressive multiple sclerosis (progressive MS) due 1H 2017
OGXI0.6417.5mPhase 306/30/2017Phase 3 data of Custirsen (ENSPIRIT trial) for NSCLC due 1H 2017
RARE51.641.9bPhase 306/30/2017Phase 3 data of Aceneuramic acid extended release (Ace-ER) for GNE Myopathy due 1H 2017
TKAI5.60119.7mPhase 306/30/2017Phase 3 topline data of Galeterone for castration-resistant prostate cancer (CRPC) due by mid 2017
VRTX80.1418.6bPhase 306/30/2017Phase 3 data of VX-661 in patients with cystic fibrosis - one copy of the F508del mutation and a second mutation that results in a gating mutation, due 1H 2017
VRTX80.1418.6bPhase 306/30/2017Phase 3 data of VX-661 in patients Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in residual mutation, due 1H 2017
VSAR8.58235.2mPhase 306/30/2017Phase 3 interim 6 month height velocity analysis of VRS-317 for Growth hormone deficiency in pediatric patients are due by end of 2016 and top line data on the 12 month height velocity primary endpoint is expected in mid 2017.
AIMT15.18598.2mPhase 312/31/2017Phase 3 trial of AR101 for Peanut Allergy to be completed 2H 2017
AKAO3.4457.2mPhase 312/31/2017Phase 3 top-line results of Plazomicin - EPIC trial uin patients with complicated urinary tract infections (cUTI) and NDA filing due 2H 2017
ARRY2.50322.6mPhase 312/31/2017Phase 3 data of MEK162 (ARRY-162) - MILO trial for Recurrent low-grade serous ovarian cancer (LGSOC) due 2017
AXON10.07845.5mPhase 312/31/2017Phase 3 data of RVT-101 - MINDSET trial for patients with Alzheimer's disease are due 2017
AXSM6.0185.7mPhase 312/31/2017Phase 3 trial of AXS-02 for Complex regional pain syndrome (CRPS) expected to be completed by end of 2017
EARS4.21150.3mPhase 312/31/2017Phase 3 data of AM-111 HEALOS trial for Acute inner ear hearing loss due 2017
ESPR14.31292.4mPhase 312/31/2017Phase 3 long-term safety and tolerability top-line data of Bempedoic acid (ETC-1002-040) in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins due 4Q 2017
EXEL4.24901.9mPhase 312/31/2017Phase 3 data of cabozantinib (CELESTIAL trial) for patients with advanced hepatocellular cancer (HCC) due 2017
IONS33.173.7bPhase 312/31/2017Phase 3 Nusinersen trial data due in 2017.CHERISH trial - Children with spinal muscular atrophy (SMA). ENDEAR trial - infants with spinal muscular atrophy SMA Data are due 2017
KPTI5.80196.1mPhase 1/212/31/2017Phase 1/2 data of Selinexor - STOMP trial for Multiple myeloma due 2017
MACK5.44564.2mPhase 212/31/2017Phase 2 data of MM-302 HERMIONE trial for HER2-positive locally advanced or metastatic breast cancer due 2017
MACK5.44564.2mPhase 212/31/2017Phase 2 data of MM-141 for front line pancreatic cancer due 2017
MNTA10.83698.4mPhase 1/212/31/2017Phase 1/2 topline data of Necuparanib (MOM-M402-103) for advanced metastatic pancreatic cancer due 2H 2017
NBRV8.46177.7mPhase 312/31/2017Phase 3 topline data from two trials of Lefamulin for Moderate to severe Community Acquired Bacterial Pneumonia (CABP) due late 2017
TBPH16.32602.7mPhase 212/31/2017Phase 2 data of Velusetrag (TD-5108) for Gastroparesis due 2017
TBPH16.32602.7mPhase 312/31/2017Phase 3 data of Telavancin for Bacteremia due 2017
TBPH16.32602.7mPhase 312/31/2017Phase 3 data of Telavancin for Staphylococcus aureus bacteremia due 2017
TCON6.4574.0mPhase 212/31/2017Phase 2 data of TRC105 and Nexavar for Hepatocellular carcinoma due 2017
TCON6.4574.0mPhase 212/31/2017Phase 2 data of TRC105 for Breast Cancer due 2017
VICL0.3431.1mPhase 312/31/2017Phase 3 top line data of ASP0113 Vaccine for Hematopoietic cell transplant recipients due 4Q 2017
CNAT1.6730.5mPhase 2b06/30/2018Phase 2b topline data of Emricasan for Liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT) due 1H 2018
SGEN29.043.7bPhase 306/30/2018Phase 3 data of ECHELON-1 trial of ADCETRIS in combination with chemotherapy for Frontline Hodgkin lymphoma due 2017 or by mid 2018
VTL8.65254.5mPhase 306/30/2018Phase 3 data of VTI-308 for Alcohol-induced liver decompensation, or AILD due mid 2018
ALNY59.224.6bPhase 312/31/2018Phase 3 data of Revusiran ENDEAVOUR trial for ATTR in patients with familial amyloidotic cardiomyopathy (FAC) due 2018
AMRN1.28220.1m12/31/2018REDUCE-IT outcomes trial interim efficacy look by the independent Data Monitoring Committee (DMC) due 2016 and, if not stopped early, for completion in 2017 and presentation/publication of results in 2018
GALE0.67124.4mPhase 312/31/2018Phase 3 final endpoint of NeuVax (E75) for low-to-intermediate HER2+ breast cancer is expected to be reached in 2018
MACK5.44564.2mPhase 212/31/2018Phase 2 data of MM-121 for Heregulin Positive Non-Small Cell Lung Cancer due 2018
SGEN29.043.7bPhase 312/31/2018Phase 3 data of ADCETRIS in combination with chemotherapy - ECHELON-2 trial in patients with frontline CD30-positive mature T-cell lymphomas are due 2017 or 2018

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.

190 Responses to “FDA Calendar”

  1. Ken says:

    TTNP is slated for Probuphine NDA September 2012, with Pre-NDA meeting with FDA complete. Is there a specific reason this isn’t included on your list?http://www.titanpharm.com/products.htm#gpm1_1

    • admin says:

      Hi Ken,

      Thanks for your message. I only follow companies that are listed on AMEX or NASDAQ. I haven’t followed TTNP as it is OTC listed. However, if an OTC stock has an upcoming major event, such as an NDA filing or PDUFA date, and a reader brings it to my attention then I do make exceptions.

      I’ll add the September event later tonight :)

  2. Ken says:

    Thanks. Your site is very helpful keep up the good work!

  3. Firas says:

    Where is the upcoming NDA filling from Spectrum pharmaceutical, belinostat for PTCL.
    It use to be on you list.
    Now i only see a phase 3 result, without any FDA filling to follow, why?

    • admin says:

      Hi Firas,

      Thanks for your enquiry.

      I’m not sure why the entry was deleted but I have re-entered the NDA Filing which is due to filed this year (according to its latest 10-Q) pending positive data from its Phase 3 trial.

  4. AP says:

    Please can you remove old date (Jun Date) and update it.

    Regrads,
    AP

    • admin says:

      AP,

      That’s always been a problem with the Calendar. I had a quick look at the entries. Company guidance has a few like APPA re-filing its NDA during mid-2012. I’ve got to put a date in, so for those events I’ve always put June 30 as an estimate as that is “mid-year”, when it could actually be July or even August. Maybe I’ll just change the date to read July 31. What do you (and others) think?

      The other events refer to clinical trial initiations. The problem with these is that some are so minor that some companies don’t release PRs about the initiations until they release their financial reports for that quarter, and we won’t hear from most companies till about early August. So I either wait till then for a company update, or I just delete them off the calendar. Thoughts??

  5. nimer hasan says:

    can you tell me what are the status of anth and dcth on the fda calendar

    • admin says:

      The status of ANTH and DCTH are correct as of their last PRs, although they may provide an update when they provide their 10Qs over the next few weeks.Use the “keyword” function to find ANTH and DCTH. eg. Type “DCTH” in the KEYWORD tool on the FDA Calendar. The KEYWORD function is located immediately above the FDA Calendar menu (Price, ticker, Type, catalyst date, notes)

  6. nimer hasan says:

    thanks for your prompt reply , and would like to know what does it mean for dcth to FILL NDA?AND WONDER IF IT HAS PASSED ANY PHASES ?
    THANKS IN ADVANCE
    NIMER

    • admin says:

      In late December 2010 DCTH filed their NDA for their chemosaturation system used in the treatment of patients with metastatic melanoma in the liver. Once a company files their NDA, the FDA assigns a PDUFA date to decide whether to approve the product or not. However, in early 2011 the FDA REFUSED to file DCTH’s NDA. This is rare and occurs in less than 5% of cases. They’ll get another chance soon.

  7. nimer hasan says:

    so , i understand if dcth gets the approval to fill their nda ,then they will go to phase one up to phase three later on?
    thanks

    • admin says:

      The FDA will inform the company whether their NDA filing has been accepted or not, usually 60 days after the filing. If they accept the filing then a PDUFA date (approval date) will be set, which will likely be 10-months following the filing. As an EXAMPLE, if DCTH files NDA 8/31 -> FDA informs company if NDA has been accepted or not by 10/31 -> If NDA filing has been accepted then a PDUFA date of approx 6/30/2013 will be set.

      No further trials will be required PRIOR to the PDUFA date.

      If you have any other questions please feel free to contact me using the “contact” form at the top of the website.

  8. Alpha Global Investments: Options | Alpha Global Investment says:

    […] a strangle, as it is cheaper to execute. Investors who wish to execute this strategy will find that this FDA calendar is a very helpful tool. This calendar, from BioPharmCatalyst, lists all the upcoming catalysts for […]

  9. Chad says:

    “IMGN 12/31/1969″ ?

  10. @biochaser says:

    This calendar has saved me a lot of time on research. As they say, time = money. So, I’m making another donation. Keep up the good work.

  11. Chad says:

    VTUS 3/31/12 NDA Filing. I think you mean 3/31/13?

  12. AA says:

    First, thank you for your outstanding calendar.

    Neuralstem (CUR, trades on AMEX) has a few catalysts (see third paragraph from the end of this article):

    http://seekingalpha.com/article/859871-why-neuralstem-could-provide-a-10x-return

    Could you please list them?

    Thanks again for this amazing project.

    • admin says:

      AA,

      Sorry about they dealy.

      Thanks for the feedback. I prefer to list catalysts with links to official PRs/10Qs etc rather than articles. Do you have a PR or filing handy so that I can add it with the catalyst.

      Thanks,

      BPC

  13. Steve says:

    HEB has a FDA advisory panel on December 20th for Ampligen in treating CFS.

    It is listed on page 45 of this transcript from the FDA.

    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf

  14. Pharr says:

    Great website! Thanks for your work!

  15. Chad says:

    PPHM – 6/30/12, Shouldn’t this be 13?

  16. Steve says:

    CRMD

    “CorMedix anticipates a final review and determination regarding its CE Mark application by the end of 4Q 2012. ”

    http://finance.yahoo.com/news/cormedix-successfully-completes-passes-iso-130000848.html

  17. sandy says:

    CPRX: Result of Ph II study date is delayed and in Nov 2012

    • admin says:

      Thanks. Am planning a big catch up this weekend. Have started updating my database offline but will update all changes on the website hopefully by the end of this weekend.

  18. Steve says:

    CRMD

    CorMedix anticipates a final review and determination regarding its CE Mark application by the end of 4Q 2012.

    http://finance.yahoo.com/news/cormedix-successfully-completes-passes-iso-130000848.html

  19. rx007 says:

    PDUFA date for desvenlafaxine base ER Tablets of Alembic pharmaceuticals is in december 2012. If you can find out

    • admin says:

      I know little about Alembic. From what I’ve read they filed a aNDA, which is different from a NDA, with no PDUFA date assigned. Have you got any other information, and ideally a link to a press release and then I can investigate further?

      • rx007 says:

        They have also filed, NDA under 505(b)2. Please make some efforts to find PDUFA date

        • admin says:

          I’ve spent quite a bit of time on this but have come up empty. How do you know they have filed an NDA? And how do you know it was filed under 505(b)2? If you could give me the link of your source that would help very much and I could investigate further.

  20. steve says:

    CRMD

    They are now expecting decision on CE Mark in Q1 of 2013, according to their latest 10-Q

    http://biz.yahoo.com/e/121113/crmd10-q.html

    Thanks again for the great calendar.

  21. figurine says:

    thanks for the job! great site 😉

  22. Mike says:

    Thank you for your service. Is there any way you could make your site data exportable to x-cel? This would be fantastic if you could. Thanks again.

    • admin says:

      Mike,

      I had an excel version a few years ago that could be downloaded but found readers were uploading it to their own websites so decided to cease doing that to the general public.

      Adam

  23. steve says:

    BLRX

    Updated guidance on BL-1020 Phase II/III Schizophrenia interim data to week of March 18, 2013

    http://www.biolinerx.com/default.asp?pageid=16&itemid=166

  24. Jake says:

    To the genius who set up this site and keeps it updated……THANK YOU!

    I have been trading about 95% Bio Tech. stocks for about 5 years now, and this site BY FAR makes me the most money based on the information posted.

    You can check me out at http://www.thelion.com …. Profile name JWT where the trades can not be fudged.

    If you are new here….STAY HERE. This site by far gives you the information you need to make real money….and lots of it.

    THANK YOU SO MUCH AGAIN FOR YOUR EFFORTS !!!!!

  25. Joe says:

    This site is so well put together, great work

    • admin says:

      Great to hear the positive feedback. Appreciate it! Currently working on adding more large cap companies to the calendar (e.g GILD/GSK) so it should be more of a complete calendar soon (ish).

  26. steve says:

    CRMD another delay

    As a result, we anticipate final approval for the CE Mark certification for Neutrolin during the second quarter in 2013.

    http://biz.yahoo.com/e/130306/crmd8-k.html

  27. Michael Webb says:

    NVAX – Topline data for RSV in women of childbearing age is 4/30/2013. Topline data for RSV in the elderly is 6/30/2013.

    P.S. I love this calendar. Thank you!

    • admin says:

      Thanks Michael.

      Regarding NVAX, I presume you are asking me to make the 4/30 event clearer for readers, as I already have the event noted. I will add “in women of childbearing age” to the event. As for the 6/30 data release this does not appear in the calendar as it is a Phase 1 data release. To maintain consistency in the calendar I only list upcoming data releases in either Phase 2 or 3 development.

      Regards,

      Adam

  28. Michael Webb says:

    Got it! Thank you Adam and I did not know that. You’re great dude!

  29. NYS-Esquire says:

    I am new to your site, and love it. The information is formatted in a way that makes it a quick read. However, being new to the site and new to the industry i think it might be helpful to provide new users such as myself with a brief definition of the “type” section. I understand many of your visitors many be more experienced but as a novice, I would love to learn more as a legend or definitions section would prove useful. Thanks. P.S. wonderful work.

  30. John t says:

    Great site, great resource for the bio investor, keep up the good work. Have you added something with respect to Ampligen experts speaking at the FDA workshop (Drug Development for Chronic
    Fatigue Syndrome [CFS] and Myalgic Encephalomyelitis [ME]) next week on April 25-26. This is would be related to Hemispherx new effort to make a precursor to submiiting a formal appeal to their CRL of ampligen. http://www.hemispherx.net/PDF/BioWorld March 14, 2013.pdf

    Thanks so much for your great work!

    • admin says:

      John,

      Thank you for the feedback. Regarding HEB, I only list PDUFA dates, Adcom meetings and clinical data release dates in the calendar. I prefer to keep to these guidelines for consistency purposes so unfortunately I will not be able to list the meeting you referred to.

      Regards,
      Adam

  31. Dr. KP says:

    Great site. One correction… there is no PDUFA for DEPO’s Serada anymore. They changed the name of the drug and got a rejection and have dropped it from their pipeline list.

    • admin says:

      Thanks Dr.KP,

      I know they got a resounding negative vote at the Adcom meeting in March and said that they will no longer be devoting any resources to it, and yes I see that they have removed it from their pipeline. But the PDUFA date still stands, as far as I am aware, even though they will get a CRL. Technically the FDA still need to make a decision even if DEPO have removed it from their pipe. I’m just reading their latest 10-Q and I can’t see any mention of them officially pulling the NDA. Do you know otherwise?

      Regards,

      Adam

  32. Tia Menon says:

    Why is it the FDA calendar no longer lists the tickers?

  33. Tia Menon says:

    Hi Adam,

    Thank you. Though I am late by 3 years to visit your site, I am happy that I did at least now.

    Great site.

    Thank you.

  34. John t says:

    Hi Sir, again, as always nice to see you are keeping a good work here for an informed audience. I noticed AEZS has another milestone coming up! here it goes: Phase 2 Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia. Estimated Study Completion Date: August 2013. Clinicaltrials ID NCT01614990.

    Thank you Sir.

    John.

  35. Adam C says:

    Great Site. I don’t see CRDC upcoming catalysts (Cardica, Inc) of a Premarket Notification 510(k) submission to the FDA in the 3rd quarter of CY13. Here is a reference to that: http://phx.corporate-ir.net/phoenix.zhtml?c=195013&p=irol-newsArticle&ID=1820268&highlight=

    Again, great site.

    Thank you,

    Adam C

    • admin says:

      Thanks Adam,

      Sorry for the delay. I’ve been locked out of my website for the last few days.

      Regarding your enquiry, I only cover PDUFA and catalyst events involving drugs, rather than medical devices due to the difficulty in providing accurate estimates and if I choose to add one (e.g. CRDC) then there will be an expectation to have them all added, which realistically is not possible.

      All the best with your trading!

      Regards,

      Adam

  36. Juno says:

    Hi Adam,
    Here are a few catalyst for MSTX. I think you always do a good job informing the biotech investor community, and I would like to do my piece to help out.
    1) Sickle Cell Disease – phase 3 NCT01737814 – estimated completion December 2015 ( i think this one is worthy of mention because it is the only company in the world with phase 3 clinical trials for SCD)
    2) Acute Limb Ischemia – initiate POC study in Q1 14
    3) Acute Decompensated Heart Failure – Data from POC study expected in Q1 14.

    This information is based of their recent presentation on September 10 at Rodman and Renshaw Global Investment Conference http://wsw.com/webcast/rrshq23/MSTX/

    Hope this helps!

    • admin says:

      Juno,

      Thank you for your enquiry.

      Please note the FDA Calendar contains dates of data releases and not trial initiations and/or completion of trials. Such events are included in the Company Pipeline Database. For 1) and 2) these events were already entered into the Company Pipeline database http://www.biopharmcatalyst.com/clinical-database/.

      Regarding the catalyst mentioned in 3), I only list data releases for Phase 2 and 3 trials. I do not list pre-clinical catalysts. To maintain consistency, I won’t be including the catalyst as according to the link you sent me the trial is a non-clinical POC trial in dogs.

      Thanks again.

      Adam

  37. Jonathan Thomas says:

    Awesome Site!

    I had a question about LGND’s PDUFA date for Bazedoxifene. I thought LGND lost all royalty agreements on Bazedoxifene when LGND signed over the rights to manufacture Lasofoxifene to Ethicor on July 24th of this year? And didn’t Pfizer obtain all rights to Bazedoxifene when it acquired Wyeth back in ’09? I think I might have this wrong but if LGND still has some sort of small royalty on Bazedoxifene, is that significant enough for a catalyst play?

    investor.ligand.com – Ligand Signs – License Agreement – Ethicor – Lasofoxifene

    Also, this might be another dumb question, but do you think that the FDA will use their 90-day extension on PFE for Bazedoxifene?

    Thanks for setting up this site, it made me a lot of money on VRX back in May :)

    JT

  38. Apoca says:

    Hey thanks for a great job. Really appreciate it

    Per

  39. Jason says:

    This is a great site, but how often is it updated?

    • admin says:

      Hi Jason,

      The FDA Calendar and Company Pipeline Database are both generally updated daily, or at least Mon-Thur nights. There may be a period during Xmas and other times of the year when I am overseas, which prevents me from updating the site, but it’s generally updated daily. Following reporting season I go through all events in the FDA Calendar to ensure they are up to date as I miss some of the PRs during what is a very busy time of the year. This is what I am currently doing, and the audit should be complete by next week. The news updates on the homepage take time to write up. I try and get a post out Mon-Thur nights but that’s not always possible.

      Regards,

      Adam

      Regards,

  40. Financial News, Blogs, Twits, Analysis for Momo Trade | Momentum Stocks says:

    […] 6) http://www.biopharmcatalyst.com/fda-calendar/ 7) 8) […]

  41. steve says:

    If pinksheets are allowed ACUS has upcoming catalyst in the first Q of 2014

    The validation process for the MAA has been successfully completed, and the substantive review process is now underway by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion is expected in Q1 2014

    http://www.acusphere.com/

  42. Pharma stock potential - Page 17 says:

    […] is and FDA calendar you guys might helpful: FDA Calendar | BioPharmCatalyst The stock market is never obvious. It is designed to fool most of the people, most of the […]

  43. Alfredo says:

    Great job. One of the best sources for biotech.

    FYI,

    TRLPF (OTC) has a pdufa date of Feb 28 2014 and is not in the calendar

    Trimel Pharmaceuticals Corporation (OTCMKTS:TRLPF) announced that the New Drug Application (“NDA”) for its bioadhesive intranasal gel testosterone product (“CompleoTRT™”) has been formally accepted for review by the United States Food and Drug Administration (the “FDA”). The NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.

    Additionally, the FDA has confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014.

  44. JERMAINE says:

    I NEED SOME HELP WITH TRADING STOCKS….SO FORTH AS WHAT INFO THAT COMES OUT IS GOOD OR BAD AND SO FORTH

    • admin says:

      Jermaine,

      That’s not an easy question to answer.

      In simple terms, when a trial meets an endpoint or shows efficacy with statistical improvement then this is regarded as good news. Likewise, if the trial did not meet its endpoint then this is negative. However, at times, if the good news has been priced in then you may actually see a decline in the price per share. It all depends whether the actual data exceed expectations, or not.

      To fully understand whether the data are good or not, you need to have a good understanding of science and that’s not easy to explain in an email or post.

      If you don’t understand whether the data released are positive or negative, I would highly recommend against investing/trading biotech stocks as you will most likely lose most of your money, especially when the current speculative bubble bursts.

  45. steve says:

    ACST

    Clinical Trials

    Acasti continues to make significant progress in its research and clinical development program. Recently, Acasti announced that the FDA had given it clearance to initiate a PK trial in the U.S. This is a significant milestone and a key first step towards securing regulatory approval to distribute and market CaPre® as a prescription drug in the U.S. Quintiles, the world’s largest provider of biopharmaceutical development and commercial outsourcing services, has been engaged to conduct the trial. The PK study is expected to start in the second quarter of calendar 2014 and results would be announced in the following quarter.

    http://www.acastipharma.com/en/investor-relations/press-releases/170-acasti-announces-third-quarter-results

    Thanks again for the great site

  46. steve says:

    ACST

    Patient recruitment for the Phase II TRIFECTA study, a randomized, double-blind, placebo-controlled trial is on-going and special focus is being given to recruiting patients in the moderate to severe hypertriglyceridemia population (triglyceride levels over 500 mg/dL). The Corporation continues to aim for trial completion by the first half of calendar 2014

    http://www.acastipharma.com/en/investor-relations/press-releases/170-acasti-announces-third-quarter-results

    This was the main trial I wanted to link to for ACST the PK study hasn’t started yet

  47. steve says:

    Sorry about all the duplicate posts. Thanks again

  48. Alex says:

    Hi there,
    I didn’t see ADMP (newly listed to nasdaq from otc). ADAMIS PHARMACEUTICALS has NDA filing for their Epinephrine syringe.
    From report released by CRT capital group few days ago here:

    • In Q1 2014, Adamis plans on filing its epinephrine pre-filled syringe to the FDA via the 505(b)(2) pathway. The Company expects to hear back on an approval decision by late 2014/early 2015. Adamis is partnered with Catalent, who is the contract manufacturer.

    • By mid-2014, Adamis plans to conduct a small, 80-patient study with its Taper Dry owder Inhaler (DPI) for treatment of COPD/asthma. We believe the main purpose of this trial will be to demonstrate the comparable efficacy profile of its recently acquired inhaler vs. GSK’s Advair (the “gold standard” product in the market). We believe this trial could be completed by Q4’14. Adamis will be supplied the product by 3M. ”

    if you can update this that would be great.

    Thank you

    Alex

    • admin says:

      Thanks ALex,

      I’ve added the NDA filing to the FDA Calendar and APC 1000/3000 to the Company Pipeline database as per information from their SEC filings.

  49. Grant Payne says:

    Hi there,
    I noticed that there is only one upcoming event due end of 2014 for CYTR coming up.
    But I know that, or at least believe, there were other events due in Sept 2014 for a PIII data read out.
    Also, they are supposed to be presenting at ASCO this June, unless they canceled that. But that’d be new to me.

    Can you say whether or not you’ve updated events coming up for CYTR lately, and if so removed some?

    Thanks so much for the great site!!!

    • admin says:

      Hi Grant,

      Currently CYTR do not have any candidates in Phase 3 development. A Phase 3 trial of aldoxorubicin is scheduled to commence this quarter. I keep a record of previous entries and I can say that since late December I haven’t removed any CYTR events. Prior to that, I can’t say for certain as I don’t have those records prior to late Dec 2013. They have a corporate presentation on Monday so they might give an update then.

      As for ASCO, I generally have a seperate ASCO Calendar and will try and place events there. FYI, last year’s is here http://www.biopharmcatalyst.com/asco2013/

      I track about 250 companies so there will always be some catalysts I miss out so am happy to add them if official sources are provided.

      Hope that helps.

  50. John says:

    Wasn’t there an FDA decision for CHTP in mid January? I notice the calendar shows an event on 02/12/14. Just curious, great info here.

    • admin says:

      Hi John,

      The mid-January event was a FDA Advisory Committee meeting where a panel of experts were asked to give their opinion on NORTHERA. The committee returned an overwhelming positive opinion. The FDA now have to make a final decision whether to approve NORTHERA or not. They will take into account the Advisory Committee positive opinion. While they usually make a decision in line with the opinion given by the advisory committee, the FDA do not necessarily need to do so.

      By the way, the FDA decision date (PDUFA) is February 14 (not Feb 12).

  51. Ouwen says:

    It is a good website to give updated information on FDA and phase trials. However, for historical information I can only see FDA approval history while no phase trials’ results, where can I find it? Thanks

  52. Michael says:

    Hi Admin, Love the site and use it frequently!Would you by chance know how long the FDA has to respond/review IGXT response for CRL of migraine film? IGXT submitted it March 3 and I have tried to find this information with no luck. The best I could determine its either 60 days or 6 months, but any help on this would be greatly appreciated!
    Michael

    • admin says:

      Hi Michael,

      For a resubmission, the FDA should announce a new PDUFA date 2-4 weeks following the resubmission, so you should hear back by the end of the month. The new PDUFA date would be 2-6 months following the resubmission, depending on the type of review.

      Regards,
      Adam

  53. Paul says:

    Hi Admin.

    I wonder if you have any data, or even a gut feel, for how often the FDA makes a decision BEFORE the PDUFA date that they’ve announced. Is an early decision rare? I’m thinking specifically of MNKD, who had a very positive Advisory Committee meeting on 4/1/14, prior to a scheduled PDUFA date of 4/15. The FDA just moved this back 90 days to 7/15. Speculation is that they weren’t expecting a positive Adcom and are now scrambling, although the official announcement is time to analyze more data. I’m just wondering if under circumstances like this, you’ve seen the FDA not use all their extension time, or whether the tendency is to take it all. Thanks!

    Paul

    • admin says:

      Hi Paul,

      Apologies about the delay in getting back to you. Yes, I’m sure the FDA weren’t expecting the Adcom result

      Yes, there are times when the FDA do not use all of their extension time, for example UTHR in late 2013, but there are also times when they use all of it. I would say that it is more common for the FDA to use the entire three months (eg VVUS in 2012.).

      I can’t think of a time when the FDA were so negative with their briefing notes but the Adcom issued a positive vote, COUPLED with the fact that the Adcom date was so close to the PDUFA date, so it’s difficult to compare the current situation with those cases listed above.

      Regards,

      Adam

  54. DrSeattle says:

    Hi, This is wonderful website!
    Question:
    When do FDA aspect to decide on APPY approval?

  55. SurfingKook says:

    Where is rxii?

  56. G.M. says:

    Hi Admin,
    I have a new catalyst to add to your calendar. These two companies are working in partnership (Intelgenx (IGXT) and RedHill Biopharma (RDHL)) and are expected to produce results of a comparative bioavailability clinical study of their anti-migraine VersaFilm by June 2014. I hope that you can help maintain the good work you are doing, and as always happy to donate to your hard work!!!
    http://www.intelgenx.com/investors/pressreleases/2014/2014-04-28.html

    G.M.

  57. taswell thompson says:

    Hey, Im looking for any new info for POZN ?

    • admin says:

      Thank you for your enquiry. Unfortunately, I’m not aware of any new information regarding their manufacturing issues following their recent CRL.

      Regards,

      Adam

  58. Andrew Downs says:

    Any chance in getting any data on ISR?

    • admin says:

      Andrew,

      I just came across ISR yesterday.It looks like that they don’t go through Phase 1-3 testing (from what I’ve just briefly read over the last few minutes) so if this is the case it won’t be covered here. If I’ve read this incorrectly then please let me know and I’ll look into it further.

  59. Andrew Downs says:

    Thanks for the feedback!
    I have one more of interest if you have any data on ONCS

  60. Andrew Downs says:

    IDRA is another of interest for many

  61. Andrew Downs says:

    *DJ BioLine RX Says Upcoming Efficacy Study Expected to Commence in Early 2015 >BLRX

  62. ZIGGY says:

    I try to find info about FDA approval for LPCN1021

    • admin says:

      Ziggy,

      Lipocine Inc and LPCN1021 have been added to the database. Phase 3 data are due this quarter. Assuming positive data a NDA filing will be submitted in 2H 2015, which would result in a FDA Approval (PDUFA) date in 2H 2016.

  63. ZIGGY says:

    Thank you very much.
    I am watching it very close, see what happen than

  64. ZIGGY says:

    What about nbs? Do you have any data when they will get fda approved?

  65. ZIGGY says:

    would you please explain what is “NDA Filling” and “PDUFA” – I’m kind of new in this bio topic.
    Thanks

    • admin says:

      Apologies about the delay in getting back to you.

      An NDA filing is when a company submits an application for a new drug to be approved. About a couple months after the FDA receives the NDA filing they will set a PDUFA date. The PDUFA is the date when the FDA will issue a decision whether to approve the drug, or not.

  66. Vincent Ippolito says:

    Hi there, I was just inquiring if there is a way I can access the FDA Calendar with the Catalyst Due Date fro previous years rather than only the PDUFA?

    Thank you.

  67. ric says:

    ADAM
    thanks for putting all the hard work you do to keep us updated on new developments in the bio tech industry. I am curious to know how people use this site and interpret whats on your site to make a decision if a stock is a good one to invest or not. Are there other criteria that people look at to make the decision to invest in or not and what would those criteria be if any. Is it multiple news clips, volume, technical analysis of the stock
    what prompts people to jump in or not
    this would be helpful for all beginners

  68. Tony says:

    Admin, remember to add GTHP in the list of upcoming PMA Approvals (January 24, 2015). According to GTHP “We also are anxiously awaiting word from the FDA on our PMA Amendment, which, based on FDA guidelines, could be received by January 24, 2015 or sooner.” (source: http://www.guidedinc.com)

  69. FarmaZutical says:

    Hi, Thanks a lot for your comprehensive list. Good job.

    I want to bring your attention to one of the most promising biotechs I have ever come across. It’s on the OTC and therefore not on your watchlist. But they are looking to uplist in the very near future and I think you would be glad that you invested a few hours on dd at this stage even though they are not on a major excange yet.

    Cellceutix, CTIX, recently published topline results for their breakthrough antibiotic, Brilacidin, and one single dose was found to be equivalent to 7 days of Daptomycin for ABSSSI. Brilacidin is based on a new platform for antibiotics called Defensin Mimetics and the big scoop is that there is close to zero % risk of developing resistance. Hence, this could be the sollution to the superbug problem the World is facing.

    FDA issued a QIDP designation to Brilacidin last week and the company is discussing Phase 3 protocols with FDA probably as I write this to you.

    But Brilacidin is not the only compound in the pipeline. Kevetrin is an anti cancer drug currently in Phase 1 at the Dana Farber Institute under Harvard Uni. Kevetrin activates P53 known as the guardian angel of the genome. The trial is almost fisnished with patients now advancing into cohort 10. Another big catalyst this month.

    So Cellceutic might not fit your Nasdaq requirements but it will soon. And the pipeline is one of the most interesting I have ever seen, so I would certainly find it worthy of a place on your list.

    All best and happy hollidays,
    Farma

  70. Andrew Downs says:

    Anyone have any thoughts or dates for AEMD?
    http://finance.yahoo.com/news/zacks-upgrades-aemd-buy-130000386.html

  71. Chris Hamilton says:

    One I don’t see here is CLDX. Its study completion date is estimated for June 2015 according to clinicaltrials https://clinicaltrials.gov/ct2/show/NCT01498328?term=rindopepimut&rank=1.

    • admin says:

      Chris,

      Thank you for your enquiry. I understand the guidance given by clinicaltrials.gov but in order for the trial to be added to the FDA Calendar the company needs to issue a SEC filing or PR stating that they intend to release data in June. I haven’t seen such a PR but if I have missed it then feel free to send it through.

      Regards,

      Adam

  72. Andrew Downs says:

    Any info on BIOD?
    They are supposed to provide topline results from phase2a trial of BIOD-531 in Type 2 Diabeties in early January 2015

  73. Andrew Downs says:

    Keep an eye on IPCI
    Lots of new drugs in the pipeline!

  74. Evan says:

    EDAP PMA filing in April. Please add

    Thanks

    • admin says:

      Evan,

      In order for a catalyst to be added to the calendar a company PR with the expected CATALYST DATE is required. If you have such information it would be appreciated if you could send it through and I will add it to the calendar.

      Adam

  75. Allisondbl says:

    Wonderful site! Keep up the good work!

  76. Rob says:

    SRNE, Tribeca Cynviloq Study Results due in March 2015 as per article.

    http://finance.yahoo.com/news/sorrento-provides-status-cynviloq-registrational-140000313.html

  77. samuel says:

    Thank you for the updates. Is there anyway I can subscribe to the events in google calendar.

    • admin says:

      Thank you for your enquiry.

      Currently it’s not possible to subscribe to the FDA events in the google calendar. It might be possible in the future to link the PDUFA Calendar to Google but a decision hasn’t been made on that.

      Regards,

      Adam

  78. RC says:

    JAZZ/CNCE: JZP-386 data expected in Q2 2015. http://finance.yahoo.com/news/jazz-pharmaceuticals-concert-pharmaceuticals-jzp-133000623.html

    You’re welcome! Thank you! You rock! 😀

  79. john says:

    PPHM have a shot?

  80. GB says:

    Noted that the calender states it Generally does not include large cap companies, when/why do you make exceptions to include large cap companies?

    • admin says:

      GB,

      There’s no single answer to that question but I’ll give it a go. I will update the description in the calendar.

      Yes, originally large cap companies were not included due to the sheer workload required to cover all of them and the fact that there is a limit to the number of companies that can fit into the database. However, coincidentally, just last week a decision was made to include PDUFA dates from as many companies as possible (to the best of my ability), including large cap companies so that is one reason why you will see some included.

      Some large cap companies (e.g. PCYC) were originally small cap when they were entered into the database and still remain so that’s one other reason.

      Also, coincidentally today, I added a few catalysts for AMGN, following their earnings report. I will be aiming to include more but as mentioned there is a limit in terms of the workload required and the number of entries that will fit into the database. If you’re wondering why I chose to add AMGN and not PFE/BMY who also reported yesterday, that’s simply because the catalysts were noted in the AMGN release, saving me time, but there was not a lot of detail regarding upcoming catalysts from the other two.

      Coverage of large cap companies is a work in progress. It’s not possible to include all of them but readers have requested that at least some coverage is given. There is no strict criteria as to which companies will make it into the database or not.

      Regards,

      Adam

  81. ziggy says:

    Not see in your list BNHLF, they have phase 3 completed.
    Thanks.

    • admin says:

      Ziggy,

      Thank you for your enquiry.

      I see that the stock concerned is listed on OTC. As noted on the FDA Calendar page, “Generally no OTC/PINK companies are listed unless the upcoming catalyst is a PDUFA or Advisory Committee event.” Once they have been assigned a PDUFA date following their BLA filing it’ll appear in the database.

      Regards,
      Admin

  82. Andrew Downs says:

    $BIOD Received feedback and guidance from FDA on pivotal trial design and toxicology requirements in support of NDA filing for BIOD-531; plans underway to initiate pre-clinical development studies required to initiate pivotal trials and Phase 2b multi-dose study in patients with type 2 diabetes in first half 2015

  83. Andrew Downs says:

    $CPXX catalysts are in their Quarterly and 8k, they have Phase 3 data due in Q2

  84. Vinod says:

    Admin: you are doing a great job. Keep it up. Thanks

  85. Evan says:

    EDAP has a PMA due by April 29th/15 for Ablatherm.

    It’s in the 6K on Nov.6th/14

    Can you add it to the FDA calendar please?

    Thanks

    • admin says:

      Evan,

      I read their PR

      “In order to continue the process, the Company must submit a major amendment, to include the additional information requested by the FDA, by April 29, 2015. This major amendment, which will have the same PMA number as the Company’s initial filing, may extend the FDA review period up to 180 days after submission.”

      This means that they need to submit some information by April 29. No PMA decision will occur on this day.

      Regards,

      Adam

  86. Jim says:

    Admin, Ocata Therapeutics (OCAT) was up-listed to NASDAQ on 26 Feb 2015. Please add OCAT to your tracking list. Thank you, Jim

  87. julia says:

    AAVL expects topline Ph 2a results in Wet AMD from AVA-101 in mid-2015..

  88. andre says:

    EBIO
    in Q2 of 2015
    will report top-line data for their pivotal Phase 3 clinical study for EBI-005 in pts with moderate to severe dry eye disease

    • andre says:

      from the press release:
      http://ir.elevenbio.com/releasedetail.cfm?ReleaseID=899847

      “”We completed patient enrollment in our pivotal Phase 3 clinical study for EBI-005 in patients with moderate to severe dry eye disease and expect to report top-line results from that study in the second quarter of 2015.”

      • admin says:

        Thanks Andre.

        I will wait until FGEN release their 4Q report so I have an up to date link to add to the database. I presume this will be within the next week or so.

        All other changes have been made. Regarding MRNS, I have used information from their PR a couple days ago which included guidance of Phase 3 ganaxolone data due in 1Q 2016.

  89. andre says:

    Hi
    ZFGN
    just reported data in the Phase 2 trial of beloranib, in patients with hypothalamic injury associated obesity (HIAO). You have it in the calendar for 12/31/2015

    Thank you for the great service!
    Andre

  90. andre says:

    FGEN
    FG-3019: Interim Ph 2 data in neoadjuvant pancreatic cancer (combo w/ gemcitabine and Abraxane)
    FG-3019: Phase 2 data from HBV-associated liver fibrosis

    Thanks
    –andre–

  91. andre says:

    MRNS
    you have Ph 3 for ganaxolone for 6/30/2015.
    However it is indicated for H2 of 2015

    Ph 2 data in PCDH19 female pediatric epilepsy in H1 of 2015

    thanks– andre–

  92. Fezz says:

    Halozyme (HALO) CEO said on 3/2 that she has a meeting “in weeks” and at the end of Q1- with the FDA to discuss a Phase 3 registration study on pegpH20- any word from the FDA?

    Thanks a lot!

  93. Justin says:

    Adam,

    Hi, I’m kind of new at the whole biotech stock trading and I was wondering if you know any stocks with upcoming catalyst that can drive the price up. How you you know what will increase the price and if it will be good news at all? Thanks in advance!

    -Justin

    • admin says:

      Justin,

      An example of an upcoming catalyst is ATHX. They will be reporting data on April 19. If the data are more positive than the market is expecting then you will most likely see an increase in the pps post data release. We do not know for sure if the data will be positive or negative. Prior to the release of data you will see an increase in volume in shares traded and volatility in the pps. Generally, you will see an upward movement in pps prior to the release of data but this does depend on the drug and company.

      Regards,

      Adam

  94. Top 3 short term Bios PTX, NKTR, and KERX | soyoulikebios says:

    […] with this FDA approved drug.  We have 2 catalysts (from one of my favorite websites: http://www.biopharmcatalyst.com/fda-calendar/) phase 3 data for CIPRO inhale and Amikacin inhale.  Later catalysts include the BAX 855 FDA […]

  95. Martin_435 says:

    HI Admin,

    AEZS said end 2015 is the next FDA analysis…why do you wrote 30.06.15? Do you have other information?

    Thanks
    NR
    M435

  96. My Top 5 People To Follow On Twitter & Some Free Sites: - John Welsh Trades says:

    […] FDA Calendar – Free Biotech calendar .  Very handy and useful tool.   Donate if you wish. […]

  97. Paul says:

    Hello,

    Just wanted to point out that the link for FATE’s note takes you to XOMA’s quarterly earnings.

  98. Anon says:

    Why is there nothing on Rexahn Pharm (RNN) or Isoray (ISR)?

  99. Tim says:

    Exelexis (exel)
    Fda approval date was moved to later in the year. It was originally supposed to be in August. It would be awesome if you could update this when you get a chance. Thanks

  100. Jeff Bailey says:

    Excellent site. Used info on MNKD clinical trials release date, AdCom, FDA approval, and partnership announcement to time my buy and sell.
    Would like to see you put out a stock calendar that lists the four columns of:
    Clinical trials release date
    AdCom date
    FDA review date
    Any partnership upcoming announcements
    Thanks
    Jeff Bailey

  101. Fortune says:

    keep up the good work,

  102. Eyes on Oct. 23 for Spectrum, Ligand | Awesome Investors says:

    […] in multiple myeloma patients that are unable to receive the more traditional oral therapy. The target date for the decision is October 23, with the company having initially submitted its NDA on the same day […]

  103. Importance of information and time – Ilmari's investment ideas says:

    […] free biotech catalyst calendar you can find from http://www.biopharmcatalyst.com/fda-calendar/  but it is not updated that often so the information is not always accurate and up to date so […]

  104. Tom says:

    Hello Adam,

    In which phase is it best to buy? After I buy, where do I look for good or bad info.

  105. Arty says:

    Hey great work on this website!
    I notice that you give general times such as beginning of year or mid way through year. I’m looking for a specific date that the trial period ends for a certain drug. I’m going through filings for a lot of pharmas, and i’m wondering which filing and where on the filing could i find the deadline for phase 3 trials? Not necessarily when the FDA makes their decision, but the deadline for when the company needs to be done testing for phase 3.

    • admin says:

      Arty,

      Thank you for your enquiry. Regarding your question, 95%+ of companies do not specify the exact date a Phase 3 trial will end. Instead, as you noted, timelines such as “mid xxx” or “2Q” are given. There is no deadline for a company to finish testing for a Phase 3 drug. They can take as long as they wish and it is up to them when they finish it.

      Hope that helps.

      Regards,
      Adam

  106. Nehalp says:

    Hello – Thanks for having this excellent calendar. Can you please look in ONTX and SYN ? They both were showing before 2016 update.

    • admin says:

      Nehalp,

      I can’t remember to be honest what was showing before the update but I’ve looked through the most recent PRs and see that there need to be a couple updates. I have made a slight change to ONTX. It’s not major but it appears in both the Company Pipeline Database and FDA Calendar.

      1) ONTX – Oral Rigosertib and azacitidine 09-08 trial – Interim data released December 2015. Full data to be presented 1Q 2016 with Phase 2b to be potentially initiated 2H 2016 subject to financing.

      Regarding SYN, the following two catalysts have been added to both the Company Pipeline Database and FDA Calendar.

      1) Second Phase 2 trial eight week extension data of SYN-010 for Constipation-Predominant Irritable Bowel Syndrome (C-IBS) due 1Q 2016.
      2) Topline results from the second Phase 2a trial of SYN-004 in patients with C. difficile Infection due 1H 2016

      Regards,

      Adam

  107. Nehalp1 says:

    Thanks Adam,

    Can you please look in BIND ?

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