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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
Synergy Pharmaceuticals, Inc.
Plecanatide (NDA)
FDA decision on Plecanatide for the treatment of chronic idiopathic constipation
01/29/2017
Biomarin Pharmaceutical Inc.
Cerliponase Alfa (BLA)
FDA decision on Cerliponase Alfa to treat children with CLN2 disease, a form of Batten disease
01/27/2017
Anacor Pharmaceuticals, Inc.
Crisaborole topical ointment, 2% (NDA)
FDA decision on Crisaborole for treatment of mild-to-moderate atopic dermatitis in children and adults.
01/07/2017
Vericel Corporation
MACI (BLA)
FDA decision on MACI for the treatment of symptomatic cartilage defects of the knee in adult patients
01/03/2017
Roche Holding AG
OCREVUS (BLA)
FDA decision on OCREVUS for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis
12/28/2016
Advanced Accelerator Applications S.A.
Lutathera (NDA)
FDA decision on Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors
12/28/2016
Cempra, Inc.
Solithera IV (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
12/28/2016
Cempra, Inc.
Solithera oral (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
12/27/2016
Dynavax Technologies Corp
HEPLISAV-B (BLA)
FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
12/15/2016
Spectrum Pharmaceuticals Inc
EOquin (NDA)
FDA decision on EOquin for the treatment of non-invasive bladder cancer
12/11/2016
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
11/30/2016
Valeant Pharmaceuticals International
VRX, VRX.TO
Brodalumab (BLA)
FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
11/16/2016
Dynavax Technologies Corp
HEPLISAV-B (BLA)
FDA panel review of HEPLISAV-B for immunization of adults against hepatitis B infection
11/16/2016
Gilead Sciences Inc.
Tenofovir Alafenamide (TAF) (NDA)
FDA decision on TAF for treatment of chronic hepatitis B
11/12/2016
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
11/11/2016
Pharma-082616.jpg Shares of Vanda Pharmaceuticals Inc. (VNDA) soared more than 20% on Thursday, following a favorable verdict in the patent litigation against Roxane Laboratories Inc. related to schizophrenia drug Fanapt.
Pharma-082516.jpg The FDA has turned down Amgen Inc.'s (AMGN) Parsabiv, proposed for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.
Pharma-081016.jpg Shares of Lannett Co. Inc. (LCI) were up more than 14% in extended trading on Tuesday, following better-than expected Q4 results and bright outlook for fiscal 2017.
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