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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
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
09/03/2017
Teva Pharmaceutical Industries Limited
SD-809 (NDA)
FDA decision on SD-809 for the treatment of tardive dyskinesia
08/30/2017
Celgene Corporation
Enasidenib (NDA)
FDA decision on Enasidenib for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation
08/30/2017
Pfizer Inc.
Avelumab (BLA)
FDA decision on Avelumab for treatment of metastatic urothelial carcinoma
08/27/2017
Adamas Pharmaceuticals Inc
ADS-5102 (NDA)
FDA decision on ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease
08/24/2017
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
08/10/2017
Puma Biotechnology Inc.
PB272 (Neratinib) (NDA)
FDA decision on PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer
07/21/2017
Amgen Inc.
Romosozumab (BLA)
FDA decision on Romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
07/19/2017
Ocular Therapeutix Inc.
DEXTENZA (NDA resubmission)
FDA decision on DEXTENZA for treatment of ocular pain occurring after ophthalmic surgery
07/19/2017
Radius Health, Inc.
Abaloparatide-SC (NDA)
FDA decision on Abaloparatide–SC for postmenopausal women with osteoporosis
06/30/2017
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
Supernus Pharmaceuticals, Inc.
SHP465 (NDA resubmission)
FDA decision on SHP465 for treatment of ADHD
06/20/2017
Pharma-031717.jpg Shares of Xenon Pharmaceuticals Inc. (XENE) plunged more than 50% on Friday as its investigational drug XEN801 failed to meet efficacy endpoints in a phase II trial in patients with moderate to severe acne.
April2017-032417.jpg The month of March saw many firsts in terms of new drug approvals. Now, let's take a look at the biotech stocks awaiting FDA decision in April.
Pharma-032417.jpg The FDA has approved Merck KGaA and Pfizer Inc.'s (PFE) BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, a rare and aggressive skin cancer.
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