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
Fanapt (sNDA)
FDA decision on Fanapt as a maintenance treatment of schizophrenia in adults
ZS Pharma, Inc.
ZS-9 ( NDA)
FDA decision on ZS-9 for the treatment of hyperkalemia
ACADIA Pharmaceuticals Inc
FDA decision on NUPLAZID for for the treatment of psychosis associated with Parkinson’s disease
Gilead Sciences Inc.
FDA decision on F/TAF for use in combination with other HIV antiretroviral agents
Clovis Oncology, Inc.
Rociletinib (NDA)
FDA decision on Rociletinib for mutant EGFR non-small cell lung cancer
Lightlake Therapeutics Inc.
Narcan Nasal Spray (NDA)
FDA decision on Narcan Nasal Spray to treat opioid overdose.
FDA approved Narcan Nasal Spray on Nov.19, 2015
Eagle Pharmaceuticals Inc
Ready-to-use, liquid bivalirudin (NDA)
FDA decision on RTU bivalirudin for PCI and PTCA
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
FDA approved Opdivo for treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy on Nov.23, 2015
Johnson & Johnson
Daratumumab (BLA)
FDA decision on Daratumumab as a treatment for Multiple Myeloma
FDA approved Daratumumab under brand name DARZALEX for for Multiple Myeloma on Nov.16, 2015 - 3.5 months ahead of decision date
Bristol-Myers Squibb Co.
Empliciti (BLA)
FDA decision on Empliciti for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies
FDA approved Empliciti on Nov.30, 2015 - 3 months ahead of decision date
Intercept Pharmaceuticals Inc.
Obeticholic acid (NDA)
FDA decision on Obeticholic acid for treating primary biliary cirrhosis
Titan Pharmaceuticals Inc
Probuphine (Resubmitted NDA)
FDA decision on Probuphine for the maintenance treatment of opioid dependence in adult patients
Telesta Therapeutics Inc.
Mycobacterium phlei Cell wall-Nucleic Acid complex (BLA)
FDA decision on MCNA for treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy
Sarepta Therapeutics
Eteplirsen (NDA)
FDA decision on Eteplirsen for treatment of Duchenne Muscular Dystrophy
Merck & Co Inc.
grazoprevir/elbasvir (NDA)
FDA decision on grazoprevir/elbasvir single tablet combination therapy for the treatment of adult patients with chronic HCV genotypes 1, 4 or 6.
PharmaDaily-112515.jpg Amgen (AMGN) has submitted its Biologics License Application with the FDA for ABP 501, a biosimilar candidate to AbbVie's (ABBV) Humira. The filing represents Amgen's first BLA submission using the 351(k) biosimilar pathway.
Pharma-112415.jpg Shares of Aduro BioTech Inc. (ADRO) were down 16% on Tuesday as investors were worried about a serious adverse event that was reported in the company's phase 2a clinical trial of CRS-207 and GVAX Pancreas in patients with metastatic pancreatic cancer.
Pharma-112315.jpg Shares of XBiotech (XBIT) plunged 32% in extended trading on Monday after the company revealed a mess-up in execution of a phase III study of its lead product candidate Xilonix in colorectal cancer, being conducted under the European Medicines Agency regulatory path.
Weight loss could be one key to preserving knee cartilage, according to a new study from researchers at the University of California, San Francisco. For the study the researchers reviewed health records for over 500 obese Americans. They found that over the course of four years, those that lost at least ten percent of their body weight experienced far less cartilage degeneration.
New data on the loss of brain synapses during Alzheimer's disease could help lead to a cure for the illness, according to researchers at Neuroscience Research Australia and the Dementia Research Unit of the UNSW School of Medical Sciences. "One of the first signs of Alzheimer's disease is the loss of synapses - the structures that connect neurons in the brain," said the study leader.
Children who grow up with dogs in their household are likely to suffer from less anxiety than those who don't, according to a new study from researchers at the Bassett Medical Center in New York. For the study the researchers collected data from 643 children aged 4-10 years. They found that 58 percent of the children surveyed had a pet dog at home.
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