FDA Calendar

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 ONLY 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 included.

TickerPriceMktCapTypeCatalyst Date (due by)Catalyst Notes - click for details
AMRN1.58272.5mPDUFAOriginal PDUFA Dec 20 2013 of Vascepa in patients with High Triglycerides With Mixed Dyslipidemia. Date has been extended. No exact date given
NWBO5.88329.3mPhase 3Data Monitoring Committee interim EFFICACY analysis of the Phase 3 trial of DCVax for Glioblastoma multiforme (GBM) brain cancer still pending as of March 27 2014.
ADMP5.6258.8mNDA FilingNDA 505(b)(2) submission planned for Epinephrine PFS for Anaphylaxis, likely during 1Q 2014
KMDA14.49515.1mPhase 2/3EU Phase 2/3 data of Inhaled formulation of AAT for AATD - Alpha-1 Antitrypsin deficiency, due early 2014
XLRN38.411.2bPhase 2a04/22/2014Phase 2a interim data of Sotatercept for End stage renal disease (ESRD) who are on hemodialysisdue at the National Kidney Foundation Spring Clinical Meeting in Las Vegas, Nevada in April 22-26 2014
QRXPY3.4111.7mAdvisory Committee04/22/2014Advisory Committee meeting April 22 2014 to review MOXDUO for Moderate to severe acute pain.
POZN8.70267.6mPDUFA04/25/2014PDUFA April 25 2014 of PA32540 and PA8140 for cardiovascular patients at risk for developing aspirin-associated gastric ulcers. Extension given to allow for Phase 1 pharmacokinetic data to be analysed
FLML11.26286.2mPDUFA04/28/2014PDUFA April 28 2014 for undisclosed product
CYTK9.52343.6mPhase 2bPhase 2b data of tirasemtiv (formerly CK-2017357) for Amyotrophic Lateral Sclerosis due at the American Academy of Neurology Annual Meeting in Philadelphia from April 26 to May 3 2014.
SYN2.25146.9mPhase 204/29/2014Phase 2 topline data of Trimesta in Relapsing-remitting MS in women due at the American Academy of Neurology Annual Meeting in Philadelphia from April 29-30 2014.
ENTA33.39613.2mNDA filing04/30/2014NDA filing of ABT450 for HCV due early 2Q 2014
SGYP4.34406.1mPhase 2b04/30/2014Phase 2b data of Plecanatide for Constipation-predominant irritable bowel syndrome (IBS-C) due beginning of 2Q 2014. April 30 is an estimate only based on "early April".
NYMX5.04175.7mPhase 204/30/2014Phase 2 data of NX-1207 for low grade localized prostate cancer due late 1Q or early 2Q 2014 - Date is ESTIMATE by BioPharmCatalyst.
NWBO5.88329.3mPhase 1/204/30/2014Periodic announcements regarding their Phase 1/2 trial of DCVax for inoperable solid tumor cancers due spring, summer and fall of 2014 - source Jan 2014 presentation. April 30 is an estimate only by BioPharmCatalyst. This date might occur anytime during spring.
MDCO24.551.6bPDUFA04/30/2014PDUFA April 30 2014 of cangrelor injection, for the proposed indication of reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).
ATHX2.73209.2mPhase 205/15/2014Phase 2 topline data of Multistem for Ulcerative colitis dueby early May 2014
QRXPY3.40111.7mPDUFA05/25/2014CRL Aug 2013. New PDUFA May 25 2014. Expects Adcom meeting
TRLPF0.58102.0mPDUFA05/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
DRTX12.67337.5mpdUFA06/05/2014PDUFA May 26 2014 under priority review - Dalbavancin for Acute bacterial skin and skin structure infections (ABSSSI)
BDSI7.42355.8mPDUFA06/07/2014Estimated PDUFA June 7 2014 of BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL for Opioid dependence
KERX13.461.2bPDUFA06/07/2014PDUFA Jun 7 2014 of Zerenex for Hyperphosphatemia
OREX5.30591.2mPDUFA06/10/2014PDUFA June 10 2014 for resubmission of Contrave for Obesity
NKTR10.971.4bAdvisory Committee06/11/2014Anesthetic and Analgesic Drug Products Advisory Committee meeting being convened to review the mu opioid antagonists being developed for opioid induced constipation, including naloxegol, is now tentatively scheduled for June 11-12, 2014.
NAVB1.66248.5mPDUFA06/16/2014PDUFA June 16 2014 under priority review of Lymphoseek for Head and Neck Cancer
ETRM1.67111.2mAdvisory Committee06/17/2014Advisory Committee meeting June 17 2014 for Maestro Rechargeable System as a treatment for obesity.
VTUS1.0825.3mPre NDA meeting06/19/2014Type B pre-NDA meeting on Thursday, June 19, 2014 at which the company will seek guidance on its planned new drug application (NDA) for DOLIZEM (diltiazem hydrochloride cream) in anal fissures.
CBST63.954.8bPDUFA06/20/2014PDUFA date June 20 2014 under priority review of Tedizolid phosphate for Acute bacterial skin and skin structure infections (ABSSSI)
NPSP24.552.5bPDUFA06/28/2014sNDA of GATTEX for Short Bowel Syndrome - seeking additions to label
ACST1.0579.0mPhase 206/30/2014Phase 2 trial of CaPre (TRIFECTA trial) for Hypertriglyceridemia to be completed 1H 2014
ACHN2.83273.9m06/30/2014Expects opinion from FDA by end of 1H 2014 regarding the clinical hold of Sovaprevir for Hepatitis C viral infection (HCV)
ALIOF97.2111.7bPhase 306/30/2014Phase 3 final data of Selexipagin patients with Pulmonary arterial hypertension (PAH), due mid 2014
ALKS44.126.4bPhase 306/30/2014Pivotal Aripiprazole lauroxil data in patients with schizophrenia data due 1H 2014
ANTH2.8757.5mPhase 306/30/2014Phase 3 interim data of Blisibimod for Lupus due mid 2014
ARQL1.66103.6mPhase 206/30/2014Phase 2 data of Tivantinib (ARQ 197) in NSCLC patients with a mutated form of the KRAS gene, due 1H 2014
BDSI7.42355.8mPhase 306/30/2014Phase 3 data of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in an opioid experienced patient group, expected mid 2014
BLRX2.0468.9mSafety06/30/2014Data from Phase 1/2 safety trial due mid-2014. Efficacy trial to be initiated 2H 2014
BOTA5.47191.8mPhase 206/30/2014Phase 2 top-line data of Laninamivir Octanoate (IGLOO) in adults with symptomatic influenza A or B infection, due mid 2014
CBST63.954.8bNDA filing06/30/2014NDA filing of Ceftolozane/ tazobactam CXA-201 for Complicated Intraabdominal Infections due 1H 2014
CORT3.83385.6mPhase 206/30/2014Phase 3 Interim analysis of Corlux - Korlym for Psychotic depression due 2Q 2014
ENDP57.268.7bPhase 306/30/2014Phase 3 data of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in an opioid experienced patient group, expected shortly after database lock mid 2014
FOLD1.84114.6mPhase 306/30/201412 and 24 month Phase 3 data (Study 011) of migalastat HCl for Fabry disease due 2Q 2014
FURX75.24813.0mPhase 306/30/2014NDA filing of eluxadoline for Irritable bowel syndrome due 2Q 2014
GTXI1.3299.2mPhase 206/30/2014Phase 2 data of Enobosarm for Metastatic Breast Cancer due 2Q 2014
GWPH46.20683.5mPhase 206/30/2014Phase 2 data of GWP42003 for Ulcerative colitis due mid 2014
HRTX11.68277.1mNDA filing06/30/2014NDA refiling of APF530 (Sustol) for Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) due mid 2014
IDRA2.77228.1mPhase 206/30/2014Phase 2 data of IMO-8400 for Psoriasis due 1H 2014
INCY44.547.4bNDA Filing06/30/2014sNDA filing of INCB18424 ruxolitinib in patients with Polycythemia Vera due 1H 2014
INCY44.547.4bPhase 306/30/2014Phase 3 data of Jakafi (ruxolitinib) (RELIEF trial) for disease-related symptoms in patients with Polycythemia Vera due mid-2014
INO2.52605.2mPhase 206/30/2014Phase 2 data of VGX-3100 for Cervical dysplasia due mid 2014
ISIS34.014.0bPhase 206/30/2014Phase 2 of ISIS-CRPRx for Atrial fibrillation due 1H 2014
KYTH36.01787.3mNDA Filing06/30/2014NDA filing of ATX-101 for Reduction of Localized Subcutaneous Fat in the Submental Area due 2Q 2014
LGND64.131.3bNDA filing06/30/2014NDA filing for Captisol-enabled, propylene glycol-free (PG-free) melphalan for conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma, due mid 2014
MACK4.52466.7mPhase 306/30/2014Phase 3 MM-398 data for second line pancreatic cancer due 2Q 2014
MACK4.52466.7mPhase 206/30/2014Phase 2 data of MM-121 for triple negative breast cancer cohort in the neoadjuvant setting due 2Q 2014
MDCO14.491.6bNDA filing06/30/2014sNDA filing of IONSYS for Acute postoperative pain due 1H 2014
MNTA11.10581.2mPhase 1/206/30/2014Data from Part A of M402 trial for advanced metastatic pancreatic cancer due 1H 2014
NBY1.0547.7mPhase 2b06/30/2014Phase 2b Viral conjunctivitis due to complete mid-2014
NKTR10.971.4bPhase 306/30/2014First of three Phase 3 interim analyses if REGULATE-PCI trial of REG1 for percutaneous coronary intervention (PCI) due 2Q 2014 - partnered with RGDO
NYMX5.04175.7mPhase 306/30/2014Phase 3 data of NX-1207 for BPH due 2Q 2014
OHRP9.32220.0mPhase 206/30/2014Phase 2 interim data of Squalamine Eye Drops for Neovascular (Wet) Age-related Macular Degeneration (AMD) due 2Q 2014
OGXI12.45151.9mPhase 306/30/2014Data from first Phase 3 trial of Custirsen for castrate-resistant prostate cancer due mid 2014
OPK8.143.4bPhase 306/30/2014Phase 3 data of CTAP101 Capsules (Rayaldy) for Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency, due mid-2014
OPK8.143.4bNDA filing06/30/2014NDA filing of Rolapitant (partnered with TSRO) for the prevention of chemotherapy induced nausea and vomiting, or CINV, due mid-2014
PBYI73.372.2bPhase 306/30/2014Phase 3 data of PB272 for Adjuvant treatment for HER2 positive breast cancer due 1H 2014
PBYI73.372.2bPhase 206/30/2014Phase 2 data of PB272 for HER2-positive breast cancer first line due 1H 2014
PCRX34.501.1bNDA filing06/30/2014sNDA filing due 2Q 2014 of EXPAREL as a Single-dose injection femoral nerve block for total knee arthroplasty surgery
PCYC142.686.7bNDA filing06/30/2014NDA filing of Ibrutinib for Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL) due 1H 2014
RCPT35.99797.8mPhase 206/30/2014Phase 2 top-line data expected in mid-2014 for RPC1063 in relapsing multiple sclerosis
RCPT35.99797.8mPhase 206/30/2014Phase 2 top-line data expected in mid-2014 for RPC1063 in patients with Ulcerative Colitis (UC)
RGDO6.30210.0mPhase 306/30/2014First of three Phase 3 interim analyses if REGULATE-PCI trial of REG1 for percutaneous coronary intervention (PCI) due 2Q 2014
RIGL3.20280.1mPhase 206/30/2014Phase 2 data due 2H 2014 of R348 for Chronic dry eye disease
RVX0.0mPhase 206/30/2014Phase 2 data of RVX-208 for Pre-diabetes mellitus due mid 2014
SCMP6.77297.9mPhase 306/30/2014Phase 3 trial of Amitiza/ Lubiprostone (liquid form) for Chronic idiopathic constipation due to be completed 1H 2014
SNTA3.97363.8mPhase 2/306/30/2014Phase 2/3 interim analysis of Ganetespib AML-LI trial is expected to be conducted in mid 2014
SPPI6.74440.0mNDA filing06/30/2014NDA filing for Captisol-enabled, propylene glycol-free (PG-free) melphalan for conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma, due mid 2014
SPPI6.74440.0mPhase 306/30/2014Phase 3 data due 2Q 2014 for Captisol-enabled, propylene glycol-free (PG-free) melphalan for conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.
STEM1.2569.3mPhase 1/206/30/2014Additional Phase 1/2 Interim data due mid 2014 of HuCNS-SC cells for spinal cord injury
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THLD3.83227.3mPhase 306/30/2014Phase 3 TH-302 for soft tissue sarcoma (406 trial) - interim data due mid 2014. Topline data due 1H 2015
THRX26.473.0bPhase 206/30/2014Phase 2 trial of TD-9855 for Fibromyalgia. Data due 1H 2014
THRX26.473.0bPhase 206/30/2014Phase 2 data of Velusetrag for diabetic or idiopathic gastroparesis due 1H 2014
TSRO25.05901.5mNDA filing06/30/2014NDA filing of Rolapitant for the prevention of chemotherapy induced nausea and vomiting, or CINV, due mid-2014
TSRO25.05901.5mPhase 306/30/2014Phase 3 data from third of Rolapitant for the prevention of chemotherapy induced nausea and vomiting, or CINV due 2Q 2014
TRGT3.98134.3mPhase 2b06/30/2014Phase 2b data of AZD3480 Alzheimer’s disease due by mid-2014
TRGT3.98134.3mPhase 2b06/30/2014Phase 2b topline data of TC-5214 for overactive bladder due by mid-2014
TTPH10.20263.1mPhase 306/30/2014Phase 3 Eravacycline (TP-434) for cUTI - complicated urinary tract infections. Data from the lead-in portion due in mid-2014 and top-line data mid 2015
XLRN38.411.2bPhase 206/30/2014Phase 2 dose escalation interim data of Sotatercept for Myelodysplastic syndromes (MDS) due 2Q 2014
XLRN38.411.2bPhase 206/30/2014Phase 2 dose escalation interim data of Sotatercept for b -thalassemia due 2Q 2014
XLRN38.411.2bPhase 206/30/2014Phase 2 dose escalation interim data of ACE-536 for Myelodysplastic syndromes (MDS) due 2Q 2014
XLRN38.411.2bPhase 206/30/2014Phase 2 dose escalation interim data of ACE-536 for b -thalassemia due 2Q 2014
XOMA4.21450.0mPhase 306/30/2014Phase 3 Gevokizumab data from EYEGUARD-B study for Behcet's uveitis due 1H 2014
MNKD6.252.4bPDUFA07/15/2014PDUFA extended to July 15 2014 for AFREZZA
SLXP101.066.4bPDUFA07/16/2014PDUFA date July 16, 2014 of RUCONEST for Hereditary angioedema (HAE)
ACRX10.68459.7mPDUFA07/27/2014PDUFA Jul 27 2014 of Zalviso for Post-operative pain following open abdominal surgery and hip or knee replacement surgery
ANAC15.51648.9mPDUFA07/29/2014PDUFA July 29 2014 of tavaborole for the topical treatment of onychomycosis,
AERI14.94348.4mPhase 2b07/31/2014Phase 2b data of Roclatan for Glaucoma due ear;y 3Q 2014
ICPT240.104.8bPhase 207/31/2014Phase 2 final data of Obeticholic acid (OCA) in adult nonalcoholic steatohepatitis (NASH) patients, dueJuly 2014. FLINT trial stopped early due to strong efficacy Jan 2014
MDCO24.551.6bPDUFA08/06/2014PDUFA August 6 2014 of Oritavancin for ABSSSI under priority review
SPPI6.74440.0mPDUFA08/09/2014PDUFA August 9 2014 of Belinostat for Peripheral T-Cell Lymphoma
BMY49.4682.0bPDUFA08/25/2014PDUFA date August 25 for Supplemental New Drug Application (sNDA) for ELIQUIS (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE
PFE30.25193.4bPDUFA08/25/2014PDUFA date August 25 for Supplemental New Drug Application (sNDA) for ELIQUIS (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE
GILD70.00107.6bPDUFA09/11/2014PDUFA date September 11 2014 for Idelalisib for the treatment of Refractory Indolent Non-Hodgkin’s Lymphoma
SLXP101.066.4bPDUFA09/15/2014PDUFA September 15 2014 for Budesonide foam in patients with active mild to moderate distal ulcerative colitis
NKTR10.971.4bPDUFA09/16/2014PDUFA Sept16 2014 for Naloxegol in patients with Opioid-induced constipation (OIC)
AUXL25.971.3bPDUFA09/20/2014PDUFA 20 Sept 2014 for sNDA to revise the STENDRA (avanafil) prescribing information with efficacy and safety information
VVUS5.36552.9mPDUFA09/20/2014PDUFA 20 Sept 2014 for sNDA to revise the STENDRA (avanafil) prescribing information with efficacy and safety information
ALIM6.31239.2mPDUFA09/26/2014PDUFA Sept 26 2014 of Iluvien for Diabetic macular edema
PSDV3.45100.6mPDUFA09/26/2014PDUFA Sept 26 2014 of Iluvien for Diabetic macular edema
ACST1.0579.0mPharmacokinetic (PK)09/30/2014Data from PK trial of CaPre due 3Q 2014
AMPE5.44282.4mBLA filing09/30/2014BLA of Ampion for Osteoarthritis of the Knee due 3Q 2014, pending positive trial data
CPRX2.06134.9mPhase 309/30/2014Phase 3 data of Firdapse for Lambert-Easton Myasthenic Syndrome (LEMS) due 3Q 2014
DSCO1.90160.9mPhase 2a09/30/2014Phase 2a data of Aerosurf for Respiratory Distress Syndrome due 3Q 2014
GEVA78.902.6bPhase 309/30/2014Phase 3 data of Sebelipase alfa (SBC-102) for Late onset lysosomal acid lipase deficiency (LAL Deficiency) due 3Q 2014
LPTN4.4471.5mPhase 209/30/2014Phase 2 data of iSONEP for Wet-AMD due 3Q 2014
NBIX13.451.0bPhase 309/30/2014Top-line data from Second Phase 3 trial of Elagolix for Endometriosis due 3Q 2014.
NKTR10.971.4bPhase 309/30/2014Phase 3 data of Baxter's BAX 855 for PEGylated Factor VIII therapy due 3Q 2014 - as per JPM presentation slides
NKTR10.971.4bPhase 309/30/2014SECOND of three Phase 3 interim analyses if REGULATE-PCI trial of REG1 for percutaneous coronary intervention (PCI) due end of 3Q 2014 - partnered with RGDO
RGDO6.30210.0mPhase 309/30/2014SECOND of three Phase 3 interim analyses if REGULATE-PCI trial of REG1 for percutaneous coronary intervention (PCI) due end of 3Q 2014
RLYP22.83760.4mNDA filing09/30/2014NDA filing of PATIROMER (RLY5016) for Hyperkalemiato due 3Q 2014
SNSS5.16310.1mPhase 309/30/2014Unblinding of Phase 3 trial of vosaroxin in combination with cytarabine in first relapsed or refractory AML, in 3Q 2014
GILD70.00107.6bPDUFA10/10/2014PDUFA date October 10, 2014 for the Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection
AUXL25.971.3bPDUFA10/20/2014PDUFA date scheduled for October 20, 2014, for XIAFLEX for patients with Dupuytren's Contracture
NPSP24.552.5bPDUFA10/24/2014PDUFA Oct 24 2014 for Natpara for the treatment of Hypoparathyroidism
RPRX15.98368.0m10/31/2014Head-to-head studies comparing Androxal to the leading US testosterone replacement therapy due October 2014
AEZS1.1565.0mPDUFA11/05/2014PDUFA date Nov 5 2014 of AEZS-130 for Adult Growth Deficiency
AVNR3.46526.9mPDUFA11/26/2014PDUFA November 26 2014 for AVP-825 for the treatment of acute migraine.
BCRX8.34500.0mPDUFA12/23/2014PDUFA Dec 23 2014 of Peramivir for INFLUENZA
ACAD19.441.9bNDA filing12/31/2014NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due late 2014
ADHD15.52211.6mPhase 312/31/2014Phase 3 trial of MDX (Metadoxine Extended Release (MG01CI)) for Adult ADHD to be completed end of 2014
ALKS44.126.4bPhase 312/31/2014Phase 3 trial of three-month formulation of INVEGA SUSTENNA for the treatment of Schizophrenia due to be completed 2H 2014
ALNY53.863.4bPhase 212/31/2014Phase 2 open label initial data of ALN-TTR02 (patisiran) for Familial Amyloidotic Polyneuropathy (FAP) in patients with ATTR due 2014
ALNY53.863.4bPhase 212/31/2014Phase 2 data due late 2014 of ALN-TTRsc for TTR-mediated amyloidosis (ATTR)
ARRY3.79475.5mPhase 212/31/2014Phase 2 preliminary results of ARRY 797 for LMNA-Related DCM due by the end of 2014.
ATHX2.73209.2mPhase 212/31/2014Phase 2 initial data of Multistem for Ischemic stroke due late 2014
BDSI7.42355.8mPhase 212/31/2014Phase 3 data of Clonidine gel for Painful diabetic neuropathy (PDN) potentially due by end of 2014
BIND9.58157.5mPhase 212/31/2014Phase 2 trial of BIND-014 for Prostate Cancer due to be completed in 2014
BIND9.58157.5mPhase 212/31/2014Phase 2 trial of BIND-014 for Non-small cell lung cancer (NSCLC) due to be completed in 2014
BLRX2.0468.9mPhase 212/31/2014Phase 2a final data of BL-8040 Acute myeloid leukemia (AML) due end of 2014 or early 2015
BMRN60.898.7bPhase 312/31/2014Phase 3 data of PEG-PAL for Phenylketonuria (PKU) due 4Q 2014
CCXI6.25231.0mPhase 212/31/2014Phase 2 final data of CCX140 for Diabetic nephropathy due 4Q 2014
CERS4.50324.7mPMA12/31/2014PMA decision of INTERCEPT platelets and plasma possible 2014
CLDX14.241.3bPhase 212/31/2014Phase 2 data of CDX-110 (rindopepimut) in combination with Avastin - ReACT for glioblastoma multiforme (GBM) due by end of 2014
CNAT6.0494.4mPhase 2b12/31/2014Phase 2b pharmacokinetic data and the directional movement of biomarkers and functional parameters of Emricasan for Acute-on-Chronic Liver Failure (ACLF) are due 2H 2014
CTIC3.07459.3mPhase 312/31/2014Phase 3 top-line data of Pacritinib (PERSIST-1) for Myelofibrosis due 2H 2014.
CYTR3.23179.5mPhase 212/31/2014Phase 2 prelim data of INNO-206 aldoxorubicin for relapsed glioblastoma due 2H 2014
ESPR13.76211.8mPhase 2b12/31/2014Phase 2b data of ETC-1002-008 for Hypercholesterolemia due 4Q 2014
ESPR13.76211.8mPhase 2b12/31/2014Phase 2b data of ETC-1002-009 for Hypercholesterolemia due 4Q 2014
EXEL3.29640.3mPhase 312/31/2014Phase 3 data of Vemurafenib for melanoma due 2014
EXEL3.29640.3mPhase 312/31/2014Phase 3 data due 2014 of Castration-Resistant Prostate Cancer - COMET-1
FATE7.00143.0mPhase 212/31/2014Phase 2 interim data of ProHema for Adult hematologic malignancies due 2H 2014
FOLD1.84114.6mPhase 312/31/2014Phase 3 topline data (Study 012) of migalastat HCl for Fabry disease due 2H 2014
FPRX14.92318.7mPhase 1b12/31/2014Phase 1b prelim data of FP-1039 for FGFR1 due 2H 2014
GWPH46.20683.5mPhase 312/31/2014Phase 3 top-line results of Sativex for Cancer pain from the first of two Phase 3 trials will be available towards the end of 2014.
ICPT240.14.8bPhase 312/31/2014NDA filing of Obeticholic acid (OCA) for Primary biliary cirrhosis (PBC) to be filed by end of 2014
IDIX5.46823.4mPhase 212/31/2014Phase 2 data from IDX719 and simeprevir (TMC435) - HELIX-2 Trial due 2H 2014
IMGN13.991.2bPhase 312/31/2014Phase 3 data of Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) in patients with 1st-line HER2+ Metastatic Breast Cancer due late 2014
INCY44.547.4bPhase 2b12/31/2014Phase 2b data of LY3009104 Baricitinib in patients with Psoriasis due 2014
INFI10.15490.1mPhase 212/31/2014Phase 2 topline data of IPI-145 for Asthma due 2014
INFI10.15490.1mPhase 212/31/2014Phase 2 topline data of IPI-145 in Rheumatoid Arthritis due 2014
INSV0.1925.1mNDA filing12/31/2014NDA filing of BromSite (ISV-303) for pain after cataract surgery due 2H 2014
KBIO2.3176.2mPhase 212/31/2014Phase 2 data due 4Q 2014 of KB001-A for Cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung colonization
MEIP8.48182.3mPhase 212/31/2014Phase 2 Topline data of Pracinostat in combination with Vidaza for First line intermediate-2 or high-risk Myelodysplastic Syndrome expected by December 2014
MEIP8.48182.3mPhase 212/31/2014Phase 2 Preliminary data of Pracinostat in combination with Vidaza in Elderly patients with newly diagnosed acute myeloid leukemia (AML) anticipated by December 2014.
MEIP8.48182.3mPhase 212/31/2014Phase 2 Preliminary data of Pracinostat and Vidaza or Dacogen for Refractory Myelodysplastic Syndrome anticipated by December 2014.
MGNX20.02550.0mPhase 212/31/2014Phase 2a data of Margetuximab (MGAH22) for metastatic breast cancer due 2014
MNOV1.9346.5mPhase 212/31/2014Phase 2a trial of MN-166 in patients addicted to prescription opioids or heroin, expected to proceed through mid 2014. Estimated completion 2H 2014 (BioPharmCatalyst estimate based on information from their latest annual filing and clinicaltrials.gov
NBS6.46184.6mPhase 212/31/2014Phase 2 initial data of AMR-001 for Cardiovascular disease due 3Q 2014
NKTR10.971.4bNDA filing12/31/2014NDA filing of Baxter's BAX 855 for PEGylated Factor VIII therapy due late 2014
OMER11.27381.6mPhase 212/31/2014Phase 2 interim data of OMER824 for Huntington disease due end of 2014. Final data due 2015
OGXI10.32151.9mPhase 212/31/2014Phase 2 data from Borealis-1 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer due 2H 2014
PCYC89.756.7bPhase 212/31/2014Phase 2 topline data of Ibrutinib RESONATE™-17 for Deletion 17p due 2H 2014
PTLA23.48963.4mPhase 1/212/31/2014Phase 1/2 initial data of PRT2070 for Genetically-defined hematologic cancers due 2014
PTLA23.48963.4mPhase 312/31/2014Phase 3 initial data of Andexanet alfa due 4Q 2014
RPRX15.98368.0mNDA Filing12/31/2014NDA filing of Androxal for the treatment of secondary hypogonadism late 2014
SGEN38.844.8bPhase 312/31/2014Phase 3 ADCETRIS data for post-transplant Hodgkin lymphoma (HL) patients due 2H 2014 (AETHERA)
ZIOP3.37338.9mPhase 212/31/2014Phase 2 data of Ad-RTS IL-12 in patients with melanoma due 2014
ZIOP3.37338.9mPhase 212/31/2014Phase 2 data of IL-12 in patients with breast cancer due late 2014 or 2015
ZIOP3.37338.9mPhase 312/31/2014Phase 3 data of Palifosfamide for small cell lung SCLC due 2H 2014
MDCO24.551.6bPDUFA01/31/2015PDUFA January 31, 2015 of Fibrocaps used to aid in hemostasis during surgery
AUXL25.971.3bPhase 203/31/2015Phase 2a topline data of XIAFLEX for Edematous fibrosclerotic panniculopathy (“cellulite”) due 1Q 2015
CEMP9.67321.0mPhase 3 03/31/2015Data from Phase 3 trial of CEM-101 (solithromycin) for CAPB due 1Q 2015
IMGN13.991.2bNDA filing03/31/2015Phase 3 data of Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) for 2nd-line metastatic HER2+ gastric cancer underway due early 2015. GATSBY trial
IMMU3.96329.9mPhase 303/31/2015Phase 3 data of epratuzumab in the treatment of patients with moderate to severe lupus due 1Q 2015
NKTR10.971.4bPhase 303/31/2015Phase 3 Topline data due early 2015 of Etirinotecan pegol NKTR-102 (BEACON) for Metastatic Breast Cancer
SCMP6.77297.9mPhase 303/31/2015Phase 3 interim data of Rescula (unoprostone isopropyl) for Retinitis pigmentosa due early 2015
TTPH10.20263.1mPhase 303/31/2015Phase 3 data of Eravacycline (TP-434) for cIAI (complicated intra-abdominal infections) due 1Q 2015
ACRX10.68459.7mPhase 306/30/2015Phase 3 data of ARX-04 for Moderate-to-severe acute pain due 2H 2015
AERI14.94348.4mPhase 306/30/2015Phase 3 data of Rhopressa for Glaucoma due mid-2015
ALKS44.126.4bPhase 206/30/2015Phase 2 data of ALKS 3831 for Schizophrenia due 1H 2015
ARRY3.79475.5mPhase 306/30/2015Phase 3 estimated primary completion date of Selumetinib for metastatic uveal melanoma is mid-2015
ASTM3.5221.8mPhase 2b06/30/2015Phase 2b Topline data of ixmyelocel-T in patients with ischemic dilated cardiomyopathy due 2Q 2015
BMRN60.898.7bPhase 1/206/30/2015Phase 2 data on first three cohorts in Phase 1/2 with BMN 111 for the treatment of achondroplasia due 2Q 2015
CMRX20.49548.4mPhase 306/30/2015Phase 3 data of SUPPRESS trial of CMX001 for prevention of Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT), due mid-2015
EVOK7.4145.2mPhase 306/30/2015Phase 3 data of EVK-001 for Recurrent diabetic gastroparesis in women with diabetes mellitus due mid 2015
FATE7.00143.0mPhase 206/30/2015Phase 2 data of ProHema for Adult hematologic malignancies due mid-2015
IRWD10.451.3bPhase 2a06/30/2015Phase 2a data of IW-3718 for Gastroesophageal reflux disease (GERD) due 1H 2015
KBIO2.3176.2mPhase 206/30/2015Phase 2 top-line data of KB004 for MDS and AML due 2Q 2015
NKTR10.971.4bPhase 306/30/2015Phase 3 data of Inhaled Amikacin Solution (BAY41-6551T) for Gram-Negative Pneumonia (INHALE 1) due 2015
NKTR10.971.4bPhase 306/30/2015Bayer Phase 3 program called RESPIRE of Cipro DPI (Cipro Dry Powder Inhaler) for Non-cystic fibrosis bronchiectasis. Data due mid-2015 as per JPM conference slides 2014.
NWBO5.88329.3mPhase 306/30/2015Topline data Phase 3 trial of DCVax for Glioblastoma multiforme (GBM) brain cancer due 1H 2015 according to Jan 2014 presentation
PTCT18.78564.8mPhase 306/30/2015Phase 3 top-line data of Ataluren for Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) due mid 2015
RPTP8.23514.2mPhase 2b06/30/2015Phase 2b data of DR Cysteamine for Non-alcoholic fatty liver disease (NAFLD) in children due 1H 2015
SSH5.6096.2mPivotal 06/30/2015Pivotal data due of C-Pulse Heart Assist System - OPTIONS HF study in Moderate to severe heart failure, 2Q 2015
THLD3.83227.3mPhase 306/30/2015Phase 3 TH-302 for soft tissue sarcoma (406 trial) - interim data due mid 2014. Topline data due 1H 2015
TTPH10.20263.1mPhase 306/30/2015Phase 3 Eravacycline (TP-434) for cUTI - complicated urinary tract infections. Data from the lead-in portion due in mid-2014 and top-line data mid 2015
AMBI6.94124.7mPhase 312/31/2015Phase 3 interim data of Quizartinib for relapsed/refractory acute myeloid leukemia due 2H 2015.
ARRY3.79475.5mNDA filing12/31/2015NDA filing of MEK162 (ARRY-162) for NRAS melanoma expected 2015
BIOD2.3850.2mNDA filing12/31/2015NDA filing of Liquid glucagon for Severe hypoglycemia possible in 2015
BMRN60.898.7bPhase 1/212/31/2015Phase 1/2 data of BMN 190 for Batten Disease due 2H 2015
CYCC3.2874.4mPhase 312/31/2015Phase 3 topline data of Sapacitabine (SEAMLESS trial) for Acute myeloid leukemia, due in 2015
DVAX1.5394.3mPhase 312/31/2015Company expects that all follow-up will be completed by 4Q 2015 of Phase 3 trial of HEPLISAV for Hepatitis B
GWPH46.20683.5mPhase 2b12/31/2015Estimated completion date of GWP42004 for Type 2 diabetes due 2H 2015
GWPH46.20683.5mPhase 212/31/2015Estimated completion date of GWP42003 for Schizophrenia due 2H 2015
IMGN13.991.2bNDA filing12/31/2015NDA filing of Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) for 2nd-line metastatic HER2+ gastric cancer underway due 2015
INCY44.547.4bPhase 212/31/2015Phase 2 data of LY3009104 Baricitinib for Diabetic nephropathy due 2015
NSPR2.4685.9mIDE12/31/2015Data due 4Q 2015 from MGuard Master 2 trial for STEMI - ST segment elevation myocardial infarction to support their Investigational Device Exemption (IDE) support trial
OMER11.27381.6mPhase 212/31/2015Phase 2 final data of OMER824 for Huntington disease due end of 2014. Final data due 2015
OPK8.233.4bPhase 312/31/2015Phase 3 data of hGH-CTP for adults with growth hormone deficiency due 2H 2015
PCYC89.756.7bPhase 312/31/2015Phase 3 Ibrutinib RESONATE -2 data in newly diagnosed elderly CLL/SLL patients, 2H 2015
SGMO13.99933.0mPhase 212/31/2015Phase 2 data of CERE-110 for Alzheimer's Disease due 2015
SNTA3.97363.8mPhase 312/31/2015Phase 3 interim analysis of Ganetespib GALAXY-2 to be conducted in 2H 2015
AMBI10.10180.9mPhase 303/31/2016Phase 3 topline data of Quizartinib for relapsed/refractory acute myeloid leukemia due 1Q 2016
DSCI9.43237.1mPhase 303/31/2016Phase 3 data of DSC127 for Diabetic foot ulcers early 2016
SCMP6.77297.9mPhase 303/31/2016Phase 3 completion of Lubiprostone for Pediatric functional constipation due early 2016
NKTR10.971.4bPhase 306/30/2016Phase 3 initial topline data of Fovista for Wet-AMD due mid 2016
OPHT31.771.1bPhase 306/30/2016Phase 3 initial topline data of Fovista for Wet-AMD due mid2016
OPXA1.4941.0mPhase 2b06/30/2016Phase 2b top-line data of Tovaxin (Tcelna) for Secondary Progressive MS (SPMS) due mid 2016.
SNTA3.97363.8mPhase 306/30/2016Phase 3 final analysis of Ganetespib GALAXY-2 to be conducted in 1H 2016
SSH5.6096.2mPivotal 06/30/2016Pivotal trial data of C-Pulse Heart Assist System (COUNTER HF trial) due to be completed mid-2016
ABBV48.5577.5bNDA filing12/31/2016NDA Filing of Elagolix for endometriosis due 2016
MNOV1.9346.5mPhase 2b12/31/2016Phase 2b data of MN-166 for Progressive multiple sclerosis (progressive MS) due 2016
NBIX13.451.0bNDA filing12/31/2016NDA Filing of Elagolix for endometriosis due 2016
OPK8.143.4bPhase 306/30/2017Phase 3 data of Fermagate Tablets for hyperphosphatemia in CKD patients on chronic hemodialysis due 1H 2017
ONTY2.49176.1mPhase 2Phase 2 NSCLC data of PX-866 in combination with docetaxel (Taxotere) for SCCHN data due late 2013 - NOTE: TIMELINE HAS LAPSED
ONTY2.49176.1mPhase 2Phase 2 data of PX-866 + cetuximab (Erbitux) for SCCHN data due late 2013 - NOTE: TIMELINE HAS LAPSED

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.

97 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?

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