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
Eagle Pharmaceuticals Inc
Pemetrexed Injection (NDA)
FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
AcelRx Pharmaceuticals Inc.
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
Mylan N.V.
Pegfilgrastim (BLA)
FDA decision on Pegfilgrastim as a proposed biosimilar to Amgen's Neulasta
Flexion Therapeutics, Inc.
Zilretta (NDA)
FDA decision on Zilretta for treatment of patients with osteoarthritis of the knee
Intellipharmaceutics International
Rexista (NDA under 505(b)(2))
FDA decision on Rexista Rexista™, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
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
Teva Pharmaceutical Industries Limited
SD-809 (NDA)
FDA decision on SD-809 for the treatment of tardive dyskinesia
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
Amgen Inc.
FDA decision on expanded indication of BLINCYTO to treat Ph+ relapsed or refractory B-cell precursor ALL
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo to treat previously treated mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer patients
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