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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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Date
Company Name
Ticker
Drug
Event
Outcome
Details
10/22/2016
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.
10/19/2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
10/14/2016
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
09/25/2016
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 as a biosimilar to AbbVie’s immunosuppressant Humira
09/25/2016
Pain Therapeutics Inc
REMOXY (Resubmitted NDA)
FDA decision on REMOXY for patients with moderate-to-severe chronic pain
09/25/2016
DURECT Corp.
REMOXY (Resubmitted NDA)
FDA decision on REMOXY for patients with moderate-to-severe chronic pain
09/25/2016
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 for the treatment of plaque psoriasis, rheumatoid Arthritis
09/15/2016
Dynavax Technologies Corp
HEPLISAV-B (BLA)
FDA decision on HEPLISAV-B for immunization against hepatitis B infection in adults 18 years of age and older
FDA decision postponed to December 15, 2016
09/14/2016
Aralez Pharmaceuticals Inc.
YOSPRALA (Resubmitted NDA)
FDA decision on YOSPRALA for secondary prevention of cardiovascular disease
09/12/2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of advanced bladder cancer
08/24/2016
Amgen Inc.
Etelcalcetide (NDA)
FDA decision on Etelcalcetide for the treatment of secondary hyperparathyroidism in patients with CKD on hemodialysis
08/17/2016
Portola Pharmaceuticals Inc.
Andexanet alfa (BLA)
FDA decision on Andexanet alfa as Factor Xa inhibitor antidote
07/24/2016
Ocular Therapeutix Inc.
DEXTENZA (NDA)
FDA decision on DEXTENZA for the treatment of ocular pain following ophthalmic surgery
07/23/2016
Merck & Co Inc.
Bezlotoxumab (BLA)
FDA decision on Bezlotoxumab for prevention of C. difficile infection recurrence
pharma-042816.jpg The New Drug Application for RAYALDEE, resubmitted by OPKO Health Inc. (OPK), has been accepted for review by the FDA, and a decision is scheduled for October 22, 2016.
pharma-040716.jpg BioTelemetry Inc. (BEAT) has reported revenue of $48.6 million for the first quarter ended March 31, 2016, which is the highest quarterly revenue in the company's history, and a 12% increase over prior year.
PharmaDaily-042616.jpg The FDA panel has voted down Sarepta Therapeutics Inc.'s (SRPT) Eteplirsen, proposed for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.
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Children from lower income families suffering from allergies may suffer worse from their symptoms than those from higher income families, according to a new study from researchers at the Program for Maternal and Child Health at Northwestern Feinberg School of Medicine in Chicago. For the study the researchers reviewed data collected from 1,200 parents of food allergies.
The FDA has issued a warning that a common yeast infection drug may lead to miscarriages for some women. The FDA's warning follows a recent study from Danish researchers claiming that the drug oral fluconazole could pose some birth risks. The drug, which is marketed in the U.S. under the brand name Diflucan, currently has no warning on its label about possible birth defects.
Obesity amongst children in the U.S. has continued to rise in recent years despite various efforts to curb the trend, according to researchers from the Duke Clinical Research Institute in Durham, North Carolina. For the study the researchers reviewed data collected from kids between 1999 and 2014 and found that one-third are overweight while one quarter are obese.
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