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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
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
Gilead Sciences Inc.
Tenofovir Alafenamide (TAF) (NDA)
FDA decision on TAF for treatment of chronic hepatitis B
11/12/2016
Amgen Inc.
Enbrel (sBLA)
FDA decision on Enbrel for the expanded use to treat pediatric patients with chronic severe plaque psoriasis.
11/05/2016
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis
10/30/2016
Sanofi
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis.
10/30/2016
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis
10/30/2016
Medivation Inc.
XTANDI (sNDA)
FDA decision on XTANDI in metastatic castration-resistant prostate cancer with data from head-to-head studies of Enzalutamide Vs Bicalutamide
10/22/2016
OPKO Health Inc.
RAYALDEE (NDA Resubmission)
FDA decision on RAYALDEE for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 CKD and vitamin D insufficiency.
10/22/2016
FDA approved RAYALDEE to treat secondary hyperparathyroidism with Vitamin D Insufficiency in Stage 3-4 CKD on Jun.21, 2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
10/19/2016
Allergan Inc.
SER120 (low-dose desmopressin nasal spray) NDA
FDA panel to review SER120 for the treatment of adult onset nocturia
10/19/2016
Nicox S.A.
NICXF.PK
AC-170 (NDA)
FDA decision on AC-170 for the treatment of ocular itching associated with allergic conjunctivitis
10/18/2016
Egalet Corp.
ARYMO ER (NDA)
FDA decision on ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
10/14/2016
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