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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
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
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
10/19/2016
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
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 as a biosimilar to AbbVie’s immunosuppressant Humira
09/25/2016
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 for the treatment of plaque psoriasis, rheumatoid Arthritis
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
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
09/15/2016
FDA decision postponed to December 15, 2016
Aralez Pharmaceuticals Inc.
YOSPRALA (Resubmitted NDA)
FDA decision on YOSPRALA for secondary prevention of cardiovascular disease
09/14/2016
FDA-thumb-042916.jpg After being voted down by an FDA panel last month, Sarepta Therapeutics Inc.'s (SRPT) Duchenne Muscular Dystrophy drug candidate Eteplirsen awaits the regulatory agency's final decision, which is set for May 26, 2016.
Pharma-052416.jpg Novo Nordisk's IDegLira, which is a combination of an ultralong acting basal insulin analogue Insulin degludec and glucagonlike peptide 1 agonist Liraglutide, for the treatment of type 2 diabetes, is all set to be reviewed by an FDA advisory panel on May 24, 2016.
Pharma-051116.jpg Shares of Repros Therapeutics Inc. (RPRX) were up over 30% in extended trading on Wednesday, following positive results from a phase 2b study of oral Proellex in women with severe menstrual bleeding due to uterine fibroids.
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Prescriptions of opioids have dropped in the U.S. for the first time in twenty years, according to a new study from researchers at research group IMS Health. The firm finds that opioid prescriptions have dipped about 12 percent since 2014 and declines in prescriptions have occurred in 49 states since 2013. "The deaths are still - have still been rising."
Adults who were born as pre-term babies often have lower incomes and fewer sexual encounters, according to a new study from researchers at McMaster University in Ontario. For the study the researchers reviewed data collected on 189 adults born between 1977 and 1982. They found that by their mid-20's those born pre-term were making on-average $20,000 less per year than the term babies.
Those parents who chose to let their children "cry it out" during a meltdown are likely not hurting their kids, according to a new study from researchers at Flinders University in Adelaide, Australia. The method, referred to as "gradual extinction," proved no more harmful than other relatively gentler methods.
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