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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
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
11/16/2017
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
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for use in patients with hepatocellular carcinoma after prior sorafenib therapy
09/24/2017
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for treatment of advanced gastric or gastroesophageal junction adenocarcinoma
09/22/2017
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
BioCryst-052617.jpg Shares of BioCryst Pharmaceuticals Inc. (BCRX) are up nearly 15% over the last 5 trading days.
Slide-June2017-052317.jpg June is certainly going to be busy month for the FDA, with over 10 drug candidates looking forward to knowing their fate. Let's take a look at some of the biotech stocks awaiting FDA decision in June.
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