FDA Calendar

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
Synergy Pharmaceuticals, Inc.
Plecanatide (NDA)
FDA decision on Plecanatide for the treatment of chronic idiopathic constipation
Biomarin Pharmaceutical Inc.
Cerliponase Alfa (BLA)
FDA decision on Cerliponase Alfa to treat children with CLN2 disease, a form of Batten disease
Anacor Pharmaceuticals, Inc.
Crisaborole topical ointment, 2% (NDA)
FDA decision on Crisaborole for treatment of mild-to-moderate atopic dermatitis in children and adults.
Vericel Corporation
FDA decision on MACI for the treatment of symptomatic cartilage defects of the knee in adult patients
Roche Holding AG
FDA decision on OCREVUS for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis
Advanced Accelerator Applications S.A.
Lutathera (NDA)
FDA decision on Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors
Cempra, Inc.
Solithera IV (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
Cempra, Inc.
Solithera oral (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
Dynavax Technologies Corp
FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
Spectrum Pharmaceuticals Inc
EOquin (NDA)
FDA decision on EOquin for the treatment of non-invasive bladder cancer
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
Valeant Pharmaceuticals International
Brodalumab (BLA)
FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
Dynavax Technologies Corp
FDA panel review of HEPLISAV-B for immunization of adults against hepatitis B infection
Gilead Sciences Inc.
Tenofovir Alafenamide (TAF) (NDA)
FDA decision on TAF for treatment of chronic hepatitis B
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
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.
Too many hours of sitting may be dangerous even for those with active lifestyles, according to a new study from researcher at the Center for Cardiovascular Lifestyle Medicine at Winthrop-University Hospital in Mineola, N.Y. "All studies are indicating that moving more throughout the day -- in addition to getting the recommended 30 minutes of moderate activity on a daily basis . . ."
Replacing even just one sugary beverage a day with water could significantly improve health, according to a new study from researchers at Virginia Tech. For the study the researches pulled data from the 2007-2012 National Health and Nutrition Examination Surveys. "We found that among US adults who consume one serving of sugar-sweetened beverages per day . . ."
Viral infections are potentially more dangerous when contracted in the morning hours, according to a new study from researchers in the U.K. And while the timing of catching a virus may not seem like a significant factor, it could make a serious difference, researchers say. "It's a big difference. The virus needs all the apparatus available at the right time . . ."
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