FDA Calendar

The FDA Calendar was last updated in late June 2015. As a result, readers should be cautioned that some information might not be “current”.

Please read HERE for more information.

2015 Biotech Calendar and beyond.

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 12/31/15, this means it is expected to occur BY 12/31/15. 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.

 

FDA Approval Calendar dates  (PDUFA dates), Phase 2 & 3 trial data releases and links to press releases and SEC filings.

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

Catalyst dates are based on press releases and company filings or other official sources (e.g. FDA).

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, with the exception of companies with PDUFA dates. Over time, clinical catalysts from large cap companies might be added. There is no strict criteria as to which companies might or might not be featured.

TickerPriceMktCapTypeCatalyst Date (due by)Catalyst Notes - click for details
ALNY128.7410.1bPhase 2 06/30/2015Phase 2 open label data of Patisiran for Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR due mid 2015
AQXP1.8820.1mPhase 206/30/2015Phase 2 data of AQX-1125 (FLAGSHIP) for Chronic obstructive pulmonary disease (COPD) due mid 2015
ARRY7.14979.3mPhase 306/30/2015Phase 3 estimated primary completion date of Selumetinib for metastatic uveal melanoma is mid-2015
ASPX100.963.2bPhase 2/306/30/2015Phase 2b topline data of SD-809 for Tardive Dyskinesia (TD) due mid 2015
ASPX100.963.2bNDA filing06/30/2015NDA filing of SD-809 for Huntington's disease (HD) due by mid 2015
AVNR16.963.3bNDA filing06/30/2015NDA resubmission of AVP-825 for Acute migraine likely 1H 2015
CLDX25.862.4bPhase 306/30/2015Phase 3 first interim analysis of CDX-110 rindopepimut - ACT IV for glioblastoma multiforme (GBM) front line due mid 2015
EBIO3.0550.2mPhase 306/30/2015Phase 3 topline data of EBI-005 for Moderate to severe dry eye disease due 2Q 2015
EGRX90.321.3bNDA filing06/30/2015NDA filing of RTU bivalirudin liquid due 2Q 2015
ESPR91.612.0bPhase 206/30/2015Phase 2 data of ETC-1002-014 for Hypercholesterolemia and hypertension due mid 2015
FATE7.89195.5mPhase 206/30/2015Phase 2 primary endpoint data of ProHema for Adult hematologic malignancies due 2H 2015
GALE1.80265.1mPhase 206/30/2015Phase 2a data of GALE 301 Folate Binding Protein (FBP) vaccine for endometrial and ovarian cancer due mid 2015
GALE1.80265.1mPhase 206/30/2015Phase 2 topline data of GALE-401 in patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET), due mid-2015.
HRTX32.781.1bNDA filing06/30/2015NDA refiling of APF530 (Sustol) for Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) due mid 2015
ICPT256.706.0bNDA filing06/30/2015Completion of NDA filing of Obeticholic acid (OCA) for Primary biliary cirrhosis (PBC) planned in 2Q 2015
IMMU4.20391.6mPhase 306/30/2015Phase 3 data of epratuzumab in the treatment of patients with moderate to severe lupus due 1H 2015
KMDA3.98143.1mPhase 2/306/30/2015Phase 3 data of KamRAB for Prophylaxis of rabies disease due 1by mid 2015
LPCN8.85157.6mPhase 306/30/2015Phase 3 data of LPCN 1021 for men with low testosterone (Low T) due mid 2015
LPTN0.345.6mPhase 206/30/2015Phase 2 data of iSONEP for Wet-AMD due 2Q 2015
MRNS14.25193.4mPhase 206/30/2015Phase 2 data of Ganaxolone for Fragile X Syndrome due 2015
NKTR12.011.6bPhase 306/30/2015Phase 3 data of Inhaled Amikacin Solution (BAY41-6551T) for Gram-Negative Pneumonia (INHALE 1) due 1H 2015
PBYI108.933.4bPhase 206/30/2015Phase 2 trial of PB272 as a Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7) due to be completed 1H 2015
QURE28.60587.5mPhase 1/206/30/2015Phase 1/2 interim data of AAV5 Gene therapy for hemophilia B due mid 2015
SRPT32.151.3bNDA Filing06/30/2015Rolling NDA filing of Eteplirsen for Duchenne muscular dystrophy to be completed mid-2015
TKMR12.27634.2mPhase 1/206/30/2015Phase 1/2 final data of TKM-PLK1 for Gastrointestinal Neuroendocrine Tumors (GI-NET) due mid-2015
VTAE10.51220.3mPhase 206/30/2015Phase 2 data of VTP-34072 forType 2 Diabetes due 2Q 2015
TCON10.60133.1mPhase 206/30/2015Phase 2 data of TRC105 for Renal Cell Carcinoma due early to mid 2016
SAGE75.262.1bPhase 2a06/30/2015Phase 2a data of SAGE-547 for Postpartum Depression due mid 2015
SAGE75.262.1bPhase 2a06/30/2015Phase 2a data of SAGE-547 for Essential tremor due mid 2015
PCYC261.2520.1bPhase 306/30/2015Phase 3 Ibrutinib RESONATE -2 data in newly diagnosed elderly CLL/SLL patients, mid 2015
PCYC261.2520.1bPhase 306/30/2015Phase 3 data of RAY (MCL3001) trial of IMBRUVICA in patients with R/R Mantle Cell Lymphoma (MCL) due 1H 2015
SYN3.79261.6mPhase 306/30/2015Phase 2 data of Trimesta Relapsing-remitting MS in women due 2Q 2015
GBIM2.5314.3mPhase 206/30/2015Phase 2 48-week results of GS-4774 - 0101 trial - for chronic hepatitis B infection are expected to be available 1H 2015
LLY88.7299.3bAdvisory Committee 07/09/2015Oncologic Drugs Advisory Committee will meet on July 9 2015 to discuss the BLA filing of necitumumab injection in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non small cell lung cancer.
XOMA4.54517.5mPhase 307/15/2015Phase 3 Gevokizumab EYEGUARD-B data for Behcet's uveitis due mid July 2015
SNY53.16134.6bPDUFA Priority Review07/24/2015PDUFA priority review date July 24 2015 for Praluent in patients with Hypercholesterolemia
REGN539.6655.3bPDUFA Priority Review07/24/2015PDUFA priority review date July 24 2015 for Praluent in patients with Hypercholesterolemia
ALKS67.059.7bPDUFA Priority Review07/24/2015Three-Month INVEGA SUSTENNA (paliperidone palmitate) for Schizophrenia. Priority Review. Estimated PDUFA July 24 2015.
JNJ99.23275.3bPDUFA Priority Review07/24/2015Three-Month INVEGA SUSTENNA (paliperidone palmitate) for Schizophrenia. Priority Review. Estimated PDUFA July 24 2015.
AMGN159.35118.7bPDUFA Priority review07/26/2015PDUFA date under priority review of July 26, 2015 for Kyprolis for Relapsed multiple myeloma
AMGN159.35118.7bPDUFA07/28/2015PDUFA July 28 2015 - Talimogene laherparepvec for Melanoma
CARA13.71304.4mPhase 207/31/2015Phase 2 topline data of CR845 for Uremic Pruritus due early 3Q 2015. July 31 estimate only based on early 3Q guidance
ASND20.90469.5mPhase 207/31/2015Phase 2 topline data of TransCon for Growth hormone deficiency in children due end of July 2015
EXEL3.92722.5mPhase 307/31/2015Phase 3 data of cabozantinib for metastatic renal cell cancer (RCC) due late 2Q or early 2015
EXEL3.92722.5mPDUFA Priority Review08/11/2015PDUFA August 11, 2015 under priority review of Vemurafenib for BRAF V600 Mutation-Positive Advanced Melanoma
SGEN48.945.9bPDUFA Priority Review08/18/2015PDUFA August 18, 2015 under priority review for ADCETRIS in the AETHERA setting for post-transplant Hodgkin lymphoma (HL) patients
ESALY68.7020.9bPDUFA08/19/2015sNDA filed Aug 19 2014. Estimated PDUFA Aug 19 2015 - Fycompa for Primary generalized tonic-clonic seizures (PGTC)
ALKS67.059.7bPDUFA08/22/2015PDUFA date August 22 2015 for Aripiprazole lauroxil for patients with Schizophrenia
AMGN159.35118.7bPDUFA08/27/2015PDUFA August 27, 2015 - Evolocumab for LDL Cholesterol-Lowering Medication
BMY69.85116.4bPDUFA08/27/2015PDUFA August 27, 2015 - Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma
CLVS58.313.0bNDA filing08/31/2015NDA filing of Rociletinib for 2nd line T790M+ NSCLC due to commence in June, and complete by July/August 2015
OPK16.807.6bPDUFA09/05/2015PDUFA Sept 5 2015 - Rolapitant for Prevention of chemotherapy induced nausea and vomiting, or CINV
TSRO60.912.3bPDUFA09/05/2015PDUFA Sept 5 2015 - Rolapitant for Prevention of chemotherapy induced nausea and vomiting, or CINV
GEVA238.608.9bPDUFA Priority Review09/08/2015PDUFA Sep 8 2015 for Late onset lysosomal acid lipase deficiency (LAL Deficiency) - under priority review
VSTM7.76267.0mPhase 209/30/2015Phase 2 interim analysis of COMMAND trial of VS-6063 in patients with mesothelioma prior to surgery due 3Q 2015
TRVN6.74258.1mPhase 2b09/30/2015Phase 2b (second trial) topline data of TRV130 for Moderate to severe acute pain due 3Q 2015
TTPH48.931.8bPhase 309/30/2015Phase 3 Eravacycline (TP-434) for cUTI - complicated urinary tract infections. Data due 3Q 2015
AERI19.28452.3mPhase 309/30/2015Phase 3 data of Rhopressa for Glaucoma due 3Q 2015 (Rocket 2)
VTL26.74637.4mPhase 309/30/2015Phase 3 preliminary data of VTI-208 for Alcohol-induced liver decompensation(AILD) due 3Q 2015
AKBA9.12252.1mPhase 2a09/30/2015Phase 2a data of AKB-6548 for Anemia related to chronic kidney disease (CKD) who are undergoing dialysis due 3Q 2015
CNAT5.2295.0mPhase 209/30/2015Phase 2 data of Emricasan for Portal Hypertension due 3Q 2015
CORI13.88247.2mPhase 2a09/30/2015Phase 2a data of MicroCor PTH for Osteoporosis due 3Q 2015
CPRX5.16404.9mNDA filing09/30/2015Rolling NDA of Firdapse for Lambert-Easton Myasthenic Syndrome (LEMS) to be completed 4Q 2015
EGLT12.34217.3mPhase 309/30/2015Top line results from their pivotal 60 mg bioequivalence study of Egalet-001, Abuse-Deterrent Morphine due in 3Q 2015
LXRX8.70839.1mPhase 309/30/2015Phase 3 topline data of LX1032 Telotristat etiprate for Carcinoid Syndrome due 3Q 2015
PLX1.86656.4mPhase 1/209/30/2015Phase 1/2 interim data of PRX-102 for Fabry disease due 3Q 2015. Full data due 4Q 2015
SGYP9.28921.9mPhase 309/30/2015Phase 3 topline data from second trial of Plecanatide for Chronic idiopathic constipation (CIC) due 3Q 2015
XNPT7.25421.8mPhase 209/30/2015Phase 2 topline data of XP23829 for Moderate-to-severe plaque psoriasis due 3Q 2015
XENE10.42139.2mPhase 2b09/30/2015Phase 2b data of TV-45070 for Osteoarthritis due 3Q 2015
ANAC126.583.6bPhase 309/30/2015Phase 3 data of AN2728 for Mild-to-moderate atopic dermatitis due 3Q 2015
ZSAN9.6499.0mPhase 209/30/2015Phase 2 topline data of ZP-Glucagon for Severe hypoglycemia due September 2015
APRI1.7289.0mPhase 2a09/30/2015Phase 2a topline data of RayVa for Secondary Raynaud's Phenomenon due 3Q 2015
MRK57.95163.9bPDUFA10/02/2015PDUFA date October 2 2015 for the supplemental Biologics License Application (sBLA) of KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC)
RLYP32.141.3bPDUFA10/21/2015PDUFA October 21 2015 for Patiromer for Oral Suspension (Patiromer FOS) in patients with Hyperkalemia
BDSI8.86452.3mPDUFA10/23/2015Announced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 2015 for BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
ENDP85.2117.5bPDUFA10/23/2015Announced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 2015 for BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
SPPI7.27478.0mPDUFA10/23/2015PDUFA October 23 2015 for Captisol-Enabled Melphalan as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
LGND104.822.0bPDUFA10/23/2015PDUFA October 23 2015 for Captisol-Enabled Melphalan as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
MACK11.751.3bPDUFA priority review10/24/2015PDUFA October 24 2015 under priority review of MM-398 for second line pancreatic cancer
SHPG256.8850.8bPDUFA Priority Review10/25/2015PDUFA date under priority review of October 25, 2015, for lifitegrast for the treatment for dry eye disease in adults
BMY69.85116.4bPDUFA10/28/2015PDUFA date for supplemental Biologics License Application (sBLA) for Yervoy for the adjuvant treatment of patients with stage 3 melanoma is October 28, 2015.
MCUR13.44205.5mPhase 310/31/2015Phase 3 data of CureXcell for Diabetic Foot Ulcers due October 2015
RPRX7.89190.8mAdvisory Committee 11/03/2015FDA Advisory Committee Meeting to discuss Androxal for the treatment of Secondary hypogonadism to be held on November 3 2015
GILD117.38168.6bPDUFA11/06/2015NDA filed approx Nov 6 2014. Estimated PDUFA Nov 6 2015 - Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide for HIV
JNJ99.23275.3bPDUFA 11/24/2015NDA filed approx Nov 24 2014. Estimated PDUFA Nov 24 2015 - YONDELIS for Advanced soft tissue sarcoma (STS)
RPRX7.89190.8mPDUFA11/30/2015PDUFA date November 30 2015 of Androxal for Secondary hypogonadism. FDA plans to schedule Advisory Committee Meeting. Date TBA.
BAX37.6520.5bPDUFA12/01/2015BLA filed about Dec 1 2014. Estimated PDUFA Dec 1 2015 - BAX 855 for Hemophilia A
BAYRY151.03122.2bPDUFA12/17/2015BLA filed about Dec 17 2014. Estimated PDUFA Dec 17 2015 - BAY 81-8973 for Hemophilia A
BAX37.6520.5bPDUFA12/22/2015BLA filed about Dec 22 2014. Estimated PDFUA Dec 22 2015 - BAX111 for Von Willebrand Disease
ALIOF149.4517.3bPDUFA12/22/2015PDUFA Dec 22 2015 of Selexipag - Uptravi for Pulmonary arterial hypertension (PAH).
TTNP0.7279.4mPhase 312/31/2015NDA filing of Probuphine for Opioid dependence, in response to CRL, due 2H 2015
AEZS0.2427.5mPhase 312/31/2015Phase 3 second interim analysis of AEZS-108 for Endometrial cancer due by end of 2015
ADMA9.54101.4mBLA filing12/31/2015BLA filing of RI-002 for Primary Immune Deficiency Diseases due 2015
CERU4.52123.3mPhase 212/31/2015Phase 2 data of CRLX101 for ovarian cancer due 2015
ACAD48.784.4bNDA filing12/31/2015NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due 2H 2015
BIND5.95114.6mPhase 212/31/2015Phase 2 final overall survival data of BIND-014 for NSCLC broad patient population due 2015
ACHN9.351.0bPhase 212/31/2015Phase 2 SVR4 results of ACH-3102 and sovaprevir with sofosbuvir for Hepatitis C viral infection (HCV) are expected 2H 2015
ACHN9.351.0bPhase 212/31/2015Phase 2 SVR4 results of ACH-3422 in combination with ACH-3102 for HCV Hepatitis C are expected 2H 2015
ADMS28.48489.9mPhase 312/31/2015Phase 3 data from first trial of ADS-5102 for Levodopa-Induced Dyskinesia expected around the end of 2015.
ALDR48.532.1bPhase 2b12/31/2015Phase 2b data of ALD403 for Migraine due 2H 2015
ALDX8.3080.9mPhase 212/31/2015Phase 2 preliminary data of NS2 for Sjögren-Larsson Syndrome (SLS) due by end of 2015
ALDX8.3080.9mPhase 212/31/2015Phase 2 preliminary data of NS2 for Acute anterior uveitis due 2H 2015
ALNY128.7410.1bPhase 212/31/2015Present data in late 2015 from ongoing Phase 2 OLE study of Revusiran in patients with TTR cardiac amyloidosis.
APRI1.7289.0mPhase 2a12/31/2015Phase 2a trial of RayVa for Secondary Raynaud's Phenomenon is expected to be completed in 2015.
ATRA63.001.3bPhase 212/31/2015Phase 2 unblinding of data of PINTA 745 for Protein-energy wasting due by end of 2015
BCRX16.281.1bPhase 2b12/31/2015Phase 2b data of BCX4161 - OPuS-2 trial - for Hereditary angioedema due by the end of 2015
BIND5.95114.6mPhase 212/31/2015Phase 2 preliminary data of BIND-014 for Advanced KRAS Mutant or Squamous NSCLC due 4Q 2015
BLRX2.29127.7mPhase 212/31/2015Phase 2a top-line data of BL-8040 Acute myeloid leukemia (AML) due 4Q 2015
BMRN147.2623.2bPhase 1/212/31/2015Phase 1/2 data of BMN 190 for Batten Disease due 2H 2015
BMRN147.2623.2bPhase 212/31/2015Phase 2/3 data of BMN-701 for Pompe Disease due 4Q 2015
CAPR4.9775.5mPhase 212/31/2015Phase 2 topline data of Cenderitide for Ambulatory heart failure due 2H 2015
CNAT5.2295.0mPhase 212/31/2015Phase 2 topline data of first part of trial of Emricasan for Liver Cirrhosis due 4Q 2015
CORT5.91631.5mPhase 1/212/31/2015Phase 1/2 data of Korlym for triple-negative breast cancer due 2015
DPRX14.43132.2mPhase 312/31/2015Phase 3 data of Locilex for Mild infections of diabetic foot ulcers, due 2H 2015
ENTA48.03838.9mPhase 2b12/31/2015Phase 2b data of ABT-493 for HCV due 2015.
FLXN24.88503.0mPhase 2b12/31/2015Phase 2b data of FX006 for Osteoarthritis of the knee due 4Q 2015.
GEVA238.608.9bPhase 1/212/31/2015Phase 1/2 preliminary data of SBC-103 for Mucopolysaccharidosis IIIB due 2H 2015
GNCA14.98348.2mPhase 212/31/2015Phase 2 topline data of GEN-004, a universal vaccine candidate against pneumococcus, due 4Q 2015
GWPH127.492.8bPhase 212/31/2015Phase 2 data of GWP42003 for Schizophrenia due 2H 2015
GWPH127.492.8bPhase 312/31/2015Top line Phase 3 data of Epidiolex for Dravet Syndrome expected by the end of 2015
GWPH127.492.8bPhase 312/31/2015Data from at least one of the two Phase 3 trials of Epidiolex for Lennox-Gastaut syndrome (LGS) due by the end of 2015
GWPH127.492.8bPhase 312/31/2015First of three Phase 3 trials of Sativex for Cancer pain failed. Data from two additional Phase 3 cancer pain trials expected 2H 2015
IMGN16.841.2bPhase 312/31/2015Phase 3 data of Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) for 2nd-line metastatic HER2+ gastric cancer due 2015
IRWD11.561.6bPhase 212/31/2015Phase 2 data of Linaclotide for Opioid-induced constipation (OIC) due 2H 2015.
IRWD11.561.6bPhase 312/31/2015Phase 3 data of Linaclotide for Chronic idiopathic constipation (CIC) due 2H 2015
HTBX6.0754.8mPhase 212/31/2015Phase 2 second interim data of HS-110 for NSCLC non-small cell lung cancer due 4Q 2015
ISIS55.676.4bPhase 212/31/2015Phase 2 data of ISIS-GCCRRx for Type 2 diabetes due 2015
LPCN8.85157.6mNDA filing12/31/2015NDA filing of LPCN 1021 for men with low testosterone (Low T) due 2H 2015
LGND104.822.0bPhase 312/31/2015Data from second Phase 3 trial of Captisol-enabled Delafloxacin IV for ABSSSI due 2H 2015
MDWD7.09152.1mPhase 212/31/2015Phase 2 data of EscharEx for Chronic and other hard-to-heal wounds due 2H 2015 (Israel)
NBIX52.184.2bPhase 312/31/2015Phase 3 data of VMAT2 NBI-98854 - Kinect 3 trial for Tardive dyskinesia due 2H 2015
NBIX52.184.2bPhase 312/31/2015Phase 3 data from second trial of Elagolix for Endometriosis due towards the end of 2015
NBIX52.184.2bPhase 2b12/31/2015Phase 2b data of Elagolix for Uterine Fibroids due 2H 2015.
OCUL24.56516.2mPhase 2b12/31/2015Phase 2b data of OTX-DP for Glaucoma and ocular hypertension due 4Q 2015
OGXI2.3855.8mPhase 312/31/2015Phase 3 data of Custirsen in combination with Jevtana (cabazitaxel) - AFFINITY trial for second-line castrate-resistant prostate due late 2015 or early 2016
PTCT49.071.6bPhase 312/31/2015Phase 3 top-line data of Ataluren for Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) due 4Q 2015
PTLA48.742.4bPhase 312/31/2015BLA filing of Andexanet alfa, Factor Xa inhibitor reversal agent due by end of 2015
PLX1.86656.4mPhase 1/212/31/2015Phase 1/2 interim data of PRX-102 for Fabry disease due 3Q 2015. Full data due 4Q 2015
RARE126.444.2bPhase 212/31/2015Phase 2 data of Triheptanoin for Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) due 2H 2015
RARE126.444.2bPhase 212/31/2015Phase 2 data of Triheptanoin for Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS) due 2H 2015
RDUS79.912.8bNDA filing12/31/2015NDA filing of Abaloparatide-SC for Osteoporosis due 2H 2015
RPTP14.801.2bPhase 2b12/31/2015Phase 2b data of RP103 for Non-alcoholic fatty liver disease (NAFLD) in children due 2H 2015
RPTP14.801.2bPhase 212/31/2015Phase 2b data of RP103 for Mitochondrial disorders including Leigh syndrome due 2015
RVNC31.21744.0mPhase 212/31/2015Phase 2 data of RT002 for Moderate to severe glabellar (frown) lines due late 2015
SGMO10.73681.6mPhase 212/31/2015Phase 2 data of CERE-110 for Alzheimer's Disease due 2015
SGMO10.73681.6mPhase 212/31/2015Phase 2 data of SB-728-1401 for HIV/AIDS due by the end of 2015
SNTA2.18282.0mPhase 312/31/2015Phase 3 interim analysis of Ganetespib GALAXY-2 to be conducted in 2H 2015
SPHS0.8314.0mPhase 312/31/2015Full data of Phase 3 trial of PRX302 for Benign prostatic hyperplasia due 2H 2015
STEM0.5354.7mPhase 212/31/2015Phase 2 interim 6 month data of HuCNS-SC cells for spinal cord injury due 2015.
TSRO60.912.3bPhase 312/31/2015Phase 3 initial data of Niraparib - NOVA for ovarian cancer due 4Q 2015.
TTPH33.191.8bNDA filing12/31/2015NDA filing of Eravacycline (TP-434) for cIAI (complicated intra-abdominal infections) due by end of 2015
VSTM7.76267.0mPhase 212/31/2015Phase 2 data of VS-6063 for KRAS-mutated NSCLC due 2H 2015
XOMA4.54517.5mPhase 312/31/2015Data from Phase 3 EYEGUARD-A and C trials due 2015
AMGN159.35118.7bBLA filing12/31/2015BLA filing of Brodalumab for Moderate-to-severe plaque psoriasis to be filed in 2015
AMGN159.35118.7bPhase 312/31/2015Phase 3 data of ABP 215 (bevacizumab) for advanced non-small cell lung cancer due 2H 2015
BLCM20.03505.4mPhase 1/212/31/2015Phase 1/2 topline data of BPX-501 for Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) due 2H 2015
NEOT11.50135.0mPhase 312/31/2015Phase 3 topline data of LIPO-202 for Reduction of central abdominal bulging due to subcutaneous fat in non-obese patients due by end of 2015
TCON10.60133.1mPhase 212/31/2015Phase 2 data of TRC105 for Soft tissue sarcoma due late 2015
ONCE61.131.5bPhase 312/31/2015Phase 3 data of SPK-RPE65 for Inherited retinal dystrophies due 2H 2015
PBYI108.933.4bPhase 212/31/2015Phase 2 data of PB272 for HER2-negative breast cancer patients who have a HER2 mutation due 2H 2015
PBYI108.933.4bPhase 212/31/2015Phase 2 data of PB272 for HER2+ MBC that has metastasized to the brain potentially due 2H 2015
TTHI2.1575.9mPhase 212/31/2015Phase 2 data of TT401 (LY2944876) for Type 2 diabetes due 4Q 2015
KERX9.941.0bPhase 312/31/2015Phase 3 trial of Auryxia for Iron deficiency anemia in non-dialysis dependent CKD patients due to be completed by end of 2015
TLOG2.8278.8mPhase 1/212/31/2015Phase 1/2 data of Birinapant for 3rd line ovarian cancer due 2015
TLOG2.8278.8mPhase 212/31/2015Phase 2 SHAPE data for Cutaneous T-Cell Lymphoma due 2015
TLOG2.8278.8mPhase 1/212/31/2015Phase 1/2 data of Birinapant for acute myelogenous leukemia or AML due 2015
ISIS55.676.4bPhase 1/212/31/2015Phase 1/2 trial data of ISIS-DMPK Rx for Myotonic Dystrophy Type 1 (DM1) due 2015
ISIS55.676.4bPhase 212/31/2015Phase 2 data of ISIS-GCCRRx for Type 2 diabetes due 2015
ISIS55.676.4bPhase 212/31/2015Phase 2 data of ISIS-APO(a)Rx for High lipoprotein(a), or Lp(a) due 2015
TNXP7.46133.1mPhase 212/31/2015Phase 2 data of TNX-201 for Episodic tension-type headache due 4Q 2015.
EGLT12.34217.3mNDA filing12/31/2015NDA filing of Egalet-001 Abuse-Deterrent Morphine planned by end of 2015
CTIC1.97352.4mNDA filing12/31/2015Data from second Phase 3 trial of Pacritinib for Myelofibrosis and NDA filing due by late 2015
MRNS14.25193.4mPhase 212/31/2015Phase 2 data of Ganaxolone for Female children with Epilepsy due 2H 2015
SPPI69.85478.0mPDUFA12/31/2015NDA filing of Apaziquone for bladder cancer due 2015
TKMR69.85634.2mPhase 212/31/2015Phase 2 data of TKM-Ebola-Guinea for Ebola due 2H 2015
FOLD14.911.6bNDA filing12/31/2015NDA filing of Migalastat HCl monotherapy for Fabry Disease due 2H 2015
SYN3.79261.6mPhase 212/31/2015Phase 2 data of SYN-004 for Constipation-Predominant Irritable Bowel Syndrome (C-IBS) due 2H 2015
SYN3.79261.6mPhase 212/31/2015Phase 2b data of SYN-004 for C. difficile Infection due 2H 2015
ACRX4.38187.1mPhase 312/31/2015Phase 3 data of ARX-04 for Moderate-to-severe acute pain due 4Q 2015
RARE126.444.2bPhase 212/31/2015Phase 2 40-week data of KRN23 for X-linked Hypophosphatemia (XLH) due late 2015 or early 2016
CARA13.71304.4mPhase 212/31/2015Phase 2 trial of Oral CR845 for Acute pain - potential data release by end of 2015
ALXA1.1623.0mPhase 212/31/2015Phase 2 data of AZ-002 for Acute repetitive seizures due by end of 2015
CLVS86.853.0bPhase 212/31/2015Phase 2 initial data of Lucitanib for breast cancer due by end of 2015
SGYP9.28921.9mPhase 312/31/2015Phase 3 data of Plecanatide for Constipation-predominant irritable bowel syndrome (IBS-C) due 4Q 2015.
OCUL24.56516.2mNDA filing12/31/2015NDA to be filed for OTX-DP for post-surgical ocular pain indication only. Phase 3 trial to be initiated in order to file a potential sNDA to include treatment of post-operative ocular inflammation
ZFGN38.08963.3mPhase 2b12/31/2015Phase 2b data of Beloranib for Severe obesity due late 2015 or very early 2016
RVNC31.21744.0mPhase 212/31/2015Phase 2 preliminary data of RT001 for Hyperhidrosis due 2H 2015
IDRA3.56417.3mPhase 1/212/31/2015Phase 1/2 data of IMO-8400 for Waldenström’s Macroglobulinemia due 4Q 2015
ONTX2.5354.9mPhase 212/31/2015Phase 2 data of Oral Rigosertib and azacitidine (09-07 trial) for Lower-Risk MDS (LR-MDS) due 2H 2015
AFMD88.72475.4mPhase 2a12/31/2015Phase 2a initial data of AFM13 for Hodgkin Lymphoma due late 2015. Final data due 2H 2016
VCEL3.6586.8mBLA filing12/31/2015BLA to be filed by end of 2015 for MACI for the treatment of Focal chondral cartilage defects in the knee.
HRTX32.781.1bPhase 212/31/2015Phase 2 data of HTX-011 for Post-operative pain due 2H 2015
ZFGN38.08963.3mPhase 301/31/2016Initial data from first of two Phase 3 trials of Beloranib for Prader-Willi Syndrome (PWS) due early 1Q 2015. End of January estimate on based on guidance of "early 1Q"
AQXP1.8820.1mPhase 203/31/2016Phase 2 data of AQX-1125 (KINSHIP) for Atopic dermatitis (AD) due by 1Q 2016
INNL14.70354.1mPhase 303/31/2016Phase 3 data of XaraColl for Post-operative pain due early 2016
MRNS14.25193.4mPhase 303/31/2016Phase 3 top-line data of Ganaxolone for Epilepsy due 1Q 2016
BMRN147.2623.2bPhase 303/31/2016Phase 3 data of PEG-PAL for Phenylketonuria (PKU) due 1Q 2016
CMRX48.322.1bPhase 303/31/2016Phase 3 data of SUPPRESS trial of Brincidofovir for prevention of Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT), due 1Q 2016
CPXX2.2472.0mPhase 303/31/2016Phase 3 initial induction response rate analysis of CPX-351 for Secondary AML due 2Q 2015. Overall survival data due 1Q 2016.
EARS5.28180.3mPhase 303/31/2016Phase 3 topline data of AM-101 for Acute inner ear tinnitus due early 2016
GWPH127.492.8bPhase 303/31/2016Phase 3 Topline data from second trial of Epidiolex for Dravet Syndrome due 1Q 2016
THLD4.45297.2mPhase 303/31/2016Phase 3 TH-302 overall survival analysis for soft tissue sarcoma (406 trial) due 2H 2015 or 1Q 2016.
MSTX0.5076.3mPhase 303/31/2016Phase 3 top-line data of ANX-188 for Sickle cell disease (EPIC trial) due 1Q 2016
PBYI108.933.4bNDA filing03/31/2016NDA filing of PB272 for the extended adjuvant HER2-positive early stage breast cancer due 1Q 2016
PTLA48.742.4bPhase 303/31/2016Phase 3 data of Betrixaban (The APEX Study) for the prevention of Venous thromboembolism (VTE) due early 2016
RIGL3.33269.5mPhase 203/31/2016Phase 2 data of R348 for Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD) due 1Q 2016
RIGL3.33269.5mPhase 203/31/2016Phase 2 data of Fostamatinib for IgA nephropathy due early 2016
SCMP18.41838.2mPhase 303/31/2016Phase 3 completion of Lubiprostone for Pediatric functional constipation due early 2016
VCEL3.6586.8mPhase 2b03/31/2016Phase 2b Topline data of ixmyelocel-T in patients with ischemic dilated cardiomyopathy due towards the end of 1Q 2016
THLD4.45297.2mPhase 303/31/2016Phase 3 topline data of TH-302 MAESTRO trial for pancreatic cancer due possibly late 2015 or early 2016
DRRX2.51295.4mNDA filing03/31/2016NDA of Remoxy expected to be refiled 1Q 2016
PTIE1.7776.9mNDA filing03/31/2016NDA of Remoxy expected to be refiled 1Q 2016
APRI1.7289.0mPhase 2b03/31/2016Phase 2b topline data of Fispemifene for men with symptomatic secondary hypogonadism due 1Q 2016
CANF2.0922.1mPhase 206/30/2016Phase 2 data of CF101 for Glaucoma due 1H 2016
INNL14.70354.1mPhase 306/30/2016Phase 3 data of Cogenzia for Diabetic foot ulcer infections due mid 2016
BOTA2.3979.3mPhase 2b06/30/2016Phase 2b top-line data of Vapendavir for Human rhinovirus (HRV) due mid 2016
CERU4.52123.3mPhase 206/30/2016Phase 2 data of CRLX101, in combination with Avastin for Relapsed Renal Cell Carcinoma due 2Q 2016
DERM20.48460.4mPhase 206/30/2016Phase 2b data of DRM01 for Acne due 1H 2016
GLMD10.40113.7mPhase 2b06/30/2016Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 1H 2016. Final Data due 2H 2016
IMMU4.20391.6mPhase 306/30/2016Phase 3 data of Clivatuzumab tetraxetan for pancreatic cancer due mid 2016
INSM25.081.5bPhase 306/30/2016Phase 3 data from one of two trials of ARIKAYCE for Non-tuberculous Mycobacterial Lung Disease data due mid 2016. Data from second trial due 2017.
ARRY7.14979.3mPhase 306/30/2016Phase 3 estimated primary completion date for the ASTRA study, Selumetinib (AZD6244) combined with radioactive iodine for differentiated thyroid cancer, is June 2016
IRWD11.561.6bPhase 2a06/30/2016Phase 2a data of IW-9179 for Gastroparesis due 1H 2016
PTN1.0639.5mPhase 306/30/2016Phase 3 top-line data of Bremelanotide for female sexual dysfunction (FSD) due mid-2016
RCPT202.526.1bPhase 206/30/2016Phase 2 topline data of RPC4046 for Eosiniphilic Esophagitis due 1H 2016
RGDO#N/A0.0mPhase 2b06/30/2016Phase 2b top-line data of Cenicriviroc (CVC) - CENTAUR trial, for Non-alcoholic steatohepatitis (NASH) are due in 2Q 2016
RIGL3.33269.5mPhase 306/30/2016Phase 3 data from two trials of Fostamatinib for Immune Thrombocytopenic Purpura (ITP) due mid-2016
SNTA2.18282.0mPhase 306/30/2016Phase 3 final analysis of Ganetespib GALAXY-2 to be conducted in 1H 2016
TRVN6.74258.1mPhase 2b06/30/2016Phase 2b data of TRV027 (BLAST-AHF) trial for Acute heart failure due 1H 2016
AMGN159.35118.7bPhase 306/30/2016Phase 3 data of Romosozumab for Postmenopausal osteoporosis due 1H 2016
TCON10.60133.1mPhase 206/30/2016Phase 1b data of TRC105 for Hepatocellular carcinoma due early 2015. Phase 2 data due early to mid 2016
TCON10.60133.1mPhase 206/30/2016Phase 2 data of TRC105 for Glioblastoma due early to mid 2016
TCON10.60133.1mPhase 206/30/2016Phase 2 data of TRC105 for Breast Cancer due mid to late 2016
MCUR13.44205.5mPhase 306/30/2016Phase 3 data of CureXcell for Venous Leg Ulcers due 1H 2016
OGXI2.3855.8mPhase 206/30/2016Phase 2 data of OGX-427 and carboplatin and pemetrexed - (SpruceTrial) for NSCLC due mid 2016
NERV5.77140.2mPhase 2b06/30/2016Phase 2b Europena data of MIN-101 for Schizophrenia due 2Q 2016
PSDV4.48119.5mPhase 306/30/2016Phase 3 data of Medidur for Posterior uveitis due 2Q 2016
RARE126.444.2bPhase 306/30/2016Phase 3 data of rhGUS for Mucopolysaccharidosis 7 (MPS 7) due mid 2016.
SCYX8.80126.6mPhase 206/30/2016Phase 2 topline data of SCY-078 for serious and life-threatening invasive fungal infections due 1H 2016
GWPH127.492.8bPhase 206/30/2016Phase 2 data of GWP42006 for Epilepsy due 1H 2016
BIOD1.1065.8mPhase 2b06/30/2016Phase 2b data of BIOD-531 for Type 2 diabetesdue mid 2016
ARRY7.14979.3mPhase 307/31/2016The Phase 3 estimated primary completion date for the SELECT-1 study, of Selumetinib (AZD6244) in Combination With Docetaxel for NSCLC second line non small lung cancer, is July 2016
ANTH3.78301.5mPhase 309/30/2016Phase 3 final data of Blisibimod for Lupus due 3Q 2016.
PRTK27.60472.5mPhase 309/30/2016Phase 3 topline data of Omadacycline for Acute bacterial skin and skin structure infections (ABSSSI) due 3Q 2016
MNOV3.8093.0mPhase 2b10/31/2016Phase 2b interim analysis of MN-166 for Progressive multiple sclerosis (progressive MS).due fall of 2016
NKTR12.011.6bPhase 312/31/2016Bayer Phase 3 program called RESPIRE of Cipro DPI (Cipro Dry Powder Inhaler) for Non-cystic fibrosis bronchiectasis. Data due 2H 2016
OGXI2.3855.8mPhase 312/31/2016Phase 3 data of Custirsen (ENSPIRIT trial) for NSCLC due 2H 2016
XENE10.42139.2mPhase 2b12/31/2016Phase 2b data of TV-45070 for Postherpetic neuralgia due 2H 2016
VSAR19.48546.8mPhase 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.
CYTR4.07222.1mPhase 312/31/2016Phase 3 PFS data of aldoxorubicin with doxorubicin for refractory soft tissue sarcomas due 2H 2016
ANTH8.76301.5mPhase 312/31/2016Phase 3 data of Blisibimod for IgA nephropathy due 2H 2016
HTBX6.0754.8mPhase 212/31/2016Phase 2 data of HS-410 for bladder cancer due 2H 2016
ALKS67.059.7bPhase 312/31/2016Phase 3 data of ALKS 5461 for Major depressive disorder due 2016.
ASPX100.963.2bPhase 312/31/2016Phase 3 topline data of SD-809 for Tardive Dyskinesia (TD) due 2016 - second pivotal trial
CYTR4.07222.1mPhase 2b12/31/2016Phase 2b data of Aldoxorubicin for relapsed/refractory small cell lung cancer due 2H 2016
DYAX27.963.9bPhase 212/31/2016Phase 2 topline data of Anti-LINGO - SYNERGY trial for relapsing forms of multiple sclerosis due 2016
GLMD10.40113.7mPhase 2b12/31/2016Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 1H 2016. Final data due 2H 2016
FLXN24.88503.0mPhase 312/31/2016Phase 2b data of FX006 for Osteoarthritis of the knee due 2H 2015. Phase 3 data due 2016. NDA filing due 2016 assuming positive data
GWPH127.492.8bPhase 2b12/31/2016Phase 2b estimated completion date of GWP42004 for Type 2 diabetes 2016
INCY116.9220.3bPhase 312/31/2016Phase 3 data from JANUS 1 trial of Ruxolitinib for pancreatic cancer due 2016.JANUS 2 data due at a later date
INSY39.002.8bPhase 312/31/2016Phase 3 data of Buprenorphine in patients with acute pain undergoing a bunionectomy procedure due 2016.
INSY39.002.8bPhase 312/31/2016Phase 3 data of Subsys in patients with Acute post-operative pain due 2016.
KPTI33.50907.0mPhase 2b12/31/2016Phase 2b trial completion of Selinexor for Diffuse Large B-Cell Lymphoma (DLBCL) to be completed around the end of 2016
MDCO33.482.2bPhase 312/31/2016Phase 3 data of CARBAVANCE for Serious Bacterial Infections Due to Gram-Negative Bacteria due 2016
NKTR12.011.6bPhase 312/31/2016Phase 3 initial topline data of Fovista for Wet-AMD due 2016
OCRX4.4781.9mPhase 2b12/31/2016Phase 2b trial of OCR-002 for Hepatic encephalopathy to be completed 2H 2016
OPHT57.851.9bPhase 312/31/2016Phase 3 initial topline data of Fovista for Wet-AMD due late 2016
OPXA0.4824.0mPhase 2b12/31/2016Phase 2b top-line data of Tovaxin (Tcelna) for Secondary Progressive MS (SPMS) due 2H 2016.
PTCT49.071.6bPhase 312/31/2016Phase 3 data of Ataluren for Nonsense mutation cystic fibrosis due 2H 2016
VTL26.74637.4mPhase 212/31/2016Phase 2 data of ELAD (VTI-212) for Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF due 2016
INCY116.9220.3bPhase 212/31/2016Phase 2 data of Ruxolitinib for Breast Cancer due 2016
INCY116.9220.3bPhase 312/31/2016Phase 3 data of Ruxolitinib - JANUS 1 and JANUS 2 trials for Pancreatic cancer due 2016
INCY116.9220.3bPhase 212/31/2016Phase 2 data of Ruxolitinib for Non-small cell lung cancer due 2016
TNXP7.46133.1mPhase 312/31/2016Phase 3 data of TNX-102 SL for Fibromyalgia due 2H 2016
SGEN48.945.9bPhase 312/31/2016Phase 3 data from ALCANZA trial of ADCETRIS for relapsed CD30-positive cutaneous T-cell lymphoma due 2016
BCLI3.3462.8mPhase 212/31/2016Phase 2 US trial of NurOwn for Amytrophic lateral sclerosis (ALS) due to be completed in 2016.
HRTX32.781.1bNDA filing12/31/2016NDA filing of HTX-019 for the prevention of chemotherapy-induced nausea and vomiting (CINV) due 2H 2016
IDRA3.56417.3mPhase 1/212/31/2016Phase 1/2 data of IMO-8400 for patients with DLBCL who harbor the MYD88 L265P mutation due 2016
AFMD88.72475.4mPhase 2a12/31/2016Phase 2a final data of AFM13 for Hodgkin Lymphoma due 2H 2016
ADMS28.48489.9mPhase 212/31/2016Phase 2 data of ADS-5102 for Multiple sclerosis (MS) due 2016
TKAI14.48303.1mPhase 312/31/2016Phase 3 topline data of Galeterone for castration-resistant prostate cancer (CRPC) due by end of 2016
DSCI6.91176.8mPhase 303/31/2017Phase 3 DSC127 data for Diabetic foot ulcers due early 2017
VTL26.74637.4mPhase 303/31/2017Phase 3 data of ELAD (VTI-210) for Severe acute alcoholic hepatitis due early 2017
PRTO17.55288.2mPhase 303/31/2017Phase 3 data of PRT-201 for Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) due 1Q 2017
VSAR19.48546.8mPhase 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.
MNOV3.8093.0mPhase 2b06/30/2017Phase 2b data of MN-166 for Progressive multiple sclerosis (progressive MS) due 1H 2017
ALKS67.059.7bPhase 206/30/2017Topline data from second Phase 2 trial of ALKS 3831 for Schizophrenia due mid 2017
OPK16.807.6bPhase 306/30/2017Phase 3 data of Fermagate Tablets for hyperphosphatemia in CKD patients on chronic hemodialysis due 1H 2017
MDWD7.09152.1mPhase 306/30/2017Phase 3 topline data of NexoBrid for Severe burns due 1H 2017
EXEL3.92722.5mPhase 312/31/2017Phase 3 data of cabozantinib (CELESTIAL trial) for patients with advanced hepatocellular cancer (HCC) due 2017
INSM25.081.5bPhase 312/31/2017Phase 3 data from one of two trials of ARIKAYCE for Non-tuberculous Mycobacterial Lung Disease data due mid 2016. Data from second trial due 2017.
RCPT202.526.1bPhase 312/31/2017Expects to complete Phase 3 program of RPC1063 for Relapsing Multiple Sclerosis (RMS) in 2017
DERM20.48460.4mPhase 312/31/2017Phase 3 data of Cimzia for Moderate-to-severe plaque psoriasis due 2017
HSGX6.2583.2mPhase 312/31/2017Phase 3 data of NeoCart for Cartilage defects in the knee due 2H 2017
FGEN23.151.4bPhase 312/31/2017Phase 3 data of Roxadustat FG-4592 for Anemia in chronic kidney disease due 2017
AMRN2.47422.2m12/31/2018REDUCE-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
GALE1.80265.1mPhase 312/31/2018Phase 3 final endpoint of NeuVax (E75) for low-to-intermediate HER2+ breast cancer is expected to be reached in 2018
SGEN48.945.9bPhase 312/31/2018Phase 3 data of ECHELON-1 trial of ADCETRIS in combination with chemotherapy for Frontline Hodgkin lymphoma due 2017 or 2018
SGEN48.945.9bPhase 312/31/2018Phase 3 data of ECHELON-2 trial of ADCETRIS in combination with chemotherapy for frontline CD30-positive mature T-cell lymphomas due 2017 or 2018
GTHP0.1111.6mPMACompany noted April 23 2015 that the PMA is under review but not under guidelines that require the agency to respond within a prescribed time limit. They expect to receive FDA approval a decision in 2015, but cannot be assured of the timing.

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.

175 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:

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