FDA Calendar

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
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
Teva Pharmaceutical Industries Limited
SD-809 (NDA)
FDA decision on SD-809 for the treatment of tardive dyskinesia
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
Pfizer Inc.
Avelumab (BLA)
FDA decision on Avelumab for treatment of metastatic urothelial carcinoma
Adamas Pharmaceuticals Inc
ADS-5102 (NDA)
FDA decision on ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
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
Amgen Inc.
Romosozumab (BLA)
FDA decision on Romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
Ocular Therapeutix Inc.
DEXTENZA (NDA resubmission)
FDA decision on DEXTENZA for treatment of ocular pain occurring after ophthalmic surgery
Radius Health, Inc.
Abaloparatide-SC (NDA)
FDA decision on Abaloparatide–SC for postmenopausal women with osteoporosis
Array BioPharma Inc.
Binimetinib (NDA)
FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
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
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.
Neos Therapeutics, Inc.
Cotempla XR-ODT (NDA resubmission)
FDA decision on Cotempla XR-ODT for the treatment of ADHD
Supernus Pharmaceuticals, Inc.
SHP465 (NDA resubmission)
FDA decision on SHP465 for treatment of ADHD
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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