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FDA Calendar

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PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Ticker
Drug
Event
Date
Outcome
Details
Array BioPharma Inc.
Binimetinib (NDA)
FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
06/30/2017
Tesaro Inc.
Niraparib (NDA)
FDA decision on Niraparib a treatment for patients with recurrent epithelial ovarian for treatment of fallopian tube, or primary peritoneal cancer
06/30/2017
Portola Pharmaceuticals Inc.
Betrixaban (NDA)
FDA decision on Betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
06/24/2017
Neos Therapeutics, Inc.
Cotempla XR-ODT (NDA resubmission)
FDA decision on Cotempla XR-ODT for the treatment of ADHD
06/20/2017
Genmab A/S
GMXAY.PK, GNMSF.OB
DARZALEX in combination with pomalidomide and dexamethasone (sBLA)
FDA decision on DARZALEX combination for relapsed or refractory multiple myeloma
06/17/2017
Coherus Biosciences, Inc.
CHS-1701 (351(k) BLA)
FDA decision on CHS-1701, a biosimilar to Neulasta
06/09/2017
TherapeuticsMD
Yuvvexy (NDA)
FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
05/07/2017
Novartis AG
LEE011 (NDA)
FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
05/01/2017
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ for locally advanced or metastatic urothelial carcinoma patients who are ineligible for cisplatin chemotherapy
04/30/2017
Ariad Pharmaceuticals Inc
Brigatinib (NDA)
FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
04/29/2017
Biomarin Pharmaceutical Inc.
Brineura (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
04/27/2017
AstraZeneca PLC
AZN.L, AZN
ZS-9 (NDA resubmission)
FDA decision on ZS-9 for the treatment of hyperkalaemia
04/18/2017
Neurocrine Biosciences Inc
INGREZZA (NDA)
FDA decision on INGREZZA for the treatment of tardive dyskinesia
04/11/2017
Roche Holding AG
Lucentis (sBLA)
FDA decision on Lucentis for the treatment of myopic choroidal neovascularization
04/11/2017
Regeneron Pharmaceuticals
Dupilumab (BLA)
FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
03/29/2017
Pharma-011217.jpg The FDA has refused to approve TESARO Inc.'s (TSRO) intravenous formulation of Rolapitant, developed for the prevention of chemotherapy-induced nausea and vomiting.
Pharma-011117.jpg Derma Sciences Inc. (DSCI) is all set to be acquired by Integra LifeSciences Holdings Corp. (IART) for $7.00 per share of common stock in cash or a total value of approximately $204 million.
Pharma-011017.jpg Shares of PTC Therapeutics Inc. (PTCT) rose over 10% on Monday, following the European Commission's positive decision granting annual renewal of the conditional marketing authorization for its treatment of nonsense mutation Duchenne muscular dystrophy, Translarna.
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