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
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
Clovis Oncology, Inc.
Rucaparib (NDA)
FDA decision on Rucaparib for the treatment of advanced mutant BRCA ovarian cancer.
Synergy Pharmaceuticals, Inc.
Plecanatide (NDA)
FDA decision on Plecanatide for the treatment of chronic idiopathic constipation
Biomarin Pharmaceutical Inc.
Brineura (Cerliponase Alfa) (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
FDA decision postponed to Apr.27, 2017
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
Merck & Co Inc.
FDA decision on KEYTRUDA for 1st line treatment treatment of patients with advanced NSCLC
Dynavax Technologies Corp
FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
Spectrum Pharmaceuticals Inc
EOquin, now Qapzola (NDA)
FDA decision on Qapzola 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
FDA decision postponed to Feb.28, 2017
Valeant Pharmaceuticals International
Brodalumab (BLA)
FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
Pharma-092716.jpg Shares of Array BioPharma Inc. (ARRY) jumped more than 81% on Monday, following positive top-line results from Part 1 of the phase III study evaluating the combination of LGX818 and MEK162 compared to Vemurafenib alone in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
pharma-092616.jpg Shares of Marinus Pharmaceuticals Inc. (MRNS) have gained over 35% in the last seven trading days in the run-up to the exploratory phase II study results of Ganaxolone, scheduled for this month.
Pharma-092316.jpg Aradigm Corp.'s (ARDM) two phase III studies of its investigational drug Pulmaquin in patients with non-cystic fibrosis bronchiectasis are proceeding as planned. The top-line data from the two trials are expected to be available in the fourth quarter of this year.
The FDA has issued up a warning that some forms of ovarian cancer tests may not be reliable. In a statement the agency has explained that several of the most reliable forms of screening are blood tests, but they may actually create spikes in the very biomarkers they are seeking. "Despite extensive research and published studies, there are currently no screening tests for ovarian cancer . . ."
The rise of e-cigarettes may be increasing the rates at which people are quitting smoking, according to a new study from researchers at the U.K. Center for Tobacco and Alcohol Studies at the University of Nottingham. For the study, the researchers examined the prevalence of smoking in the U.K. between 2014 and 2015 and found as e-cigarettes increased in popularity, more people reported quitting.
As much as 45 toxic chemicals can be found in everyday common house dust, according to a new study. The new study, which saw researchers analyze all studies that have sampled indoor environments in the United States since 2000, found that the chemicals found in dust samples came from a range of things typically found inside your home, including vinyl products, such as flooring and cosmetics.
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