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
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 oral (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
Cempra, Inc.
Solithera IV (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.
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
Amgen Inc.
Enbrel (sBLA)
FDA decision on Enbrel for the expanded use to treat pediatric patients with chronic severe plaque psoriasis.
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis.
Pharma-072616.jpg Shares of GenVec Inc. (GNVC) rose over 50% in extended trading on Monday after being notified that the FDA has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
Pharma-072516.jpg Tobira Therapeutics Inc. (TBRA) is all set to hold a teleconference and webcast at 8:30 a.m. Eastern Time today (July 25) to discuss phase IIb results for Cenicriviroc in patients with non-alcoholic steatohepatitis and liver fibrosis. Will Cenicriviroc make a mark? We will have to wait for the results.
Pharma-072016.jpg Shares of Puma Biotechnology Inc. (PBYI) were up over 20% in extended trading on Thursday, following encouraging interim 5-year invasive disease free survival results from the company's phase III trial of PB272 (Neratinib) in extended adjuvant HER2-positive early stage breast cancer.
The number of drug resistant cases of gonorrhea have increased in the U.S. in recent years, according to a new study from researchers at the Centers for Disease Control and Prevention. The agency released an official statement earlier this week noting that "the future of current treatment options may be in jeopardy."
Use of the wildly popular new gaming app Pokemon Go may help people with mental illness feel better, according to a new study from researchers at Media Psychology Research Center in Newport Beach, California. According to the Center's report, users that are otherwise largely sedentary and bound to the indoors may be getting more exercise and social interaction than normal because of the game.
Parents should be wary of their children's exposure to violence in the media, according to a new study from researchers at the American Academy of Pediatrics (AAP). According to the new statement, there is a clear and traceable connection between the amount of violence kids take in from the media and increased aggressive behavior. "With children, actual physical violence is, thankfully, rare."
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