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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
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
10/30/2017
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/24/2017
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
10/20/2017
AcelRx Pharmaceuticals Inc.
DSUVIA (NDA)
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
10/12/2017
Mylan N.V.
Pegfilgrastim (BLA)
FDA decision on Pegfilgrastim as a proposed biosimilar to Amgen's Neulasta
10/09/2017
Flexion Therapeutics, Inc.
Zilretta (NDA)
FDA decision on Zilretta for treatment of patients with osteoarthritis of the knee
10/06/2017
Intellipharmaceutics International
Rexista (NDA under 505(b)(2))
FDA decision on Rexista Rexista™, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation
09/25/2017
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
09/03/2017
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
Teva Pharmaceutical Industries Limited
SD-809 (NDA)
FDA decision on SD-809 for the treatment of tardive dyskinesia
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
Amgen Inc.
BLINCYTO (sBLA)
FDA decision on expanded indication of BLINCYTO to treat Ph+ relapsed or refractory B-cell precursor ALL
08/14/2017
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
08/10/2017
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
08/02/2017
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