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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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Date
Company Name
Ticker
Drug
Event
Outcome
Details
07/21/2016
Valeant Pharmaceuticals International
VRX, VRX.TO
VESNEO (NDA)
FDA decision on VESNEO for treatment of open angle glaucoma or ocular hypertension
07/10/2016
Amgen Inc.
Repatha
FDA decision for single-dosing option for the monthly administration of Repatha™ Injection
07/10/2016
Medicure Inc
MCUJF.OB
AGGRASTAT (NDA)
FDA decision on AGGRASTAT for the treatment of patients presenting with ST segment elevation myocardial infarction (STEMI) intended for percutaneous coronary intervention (
06/28/2016
Gilead Sciences Inc.
SOF/VEL (NDA)
FDA decision on SOF/VEL as a treatment of all genotypes of chronic Hepatitis C infection
06/28/2016
Clovis Oncology, Inc.
Rociletinib (NDA)
FDA decision on Rociletinib for mutant EGFR non-small cell lung cancer
06/28/2016
Lipocine Inc
LPCN 1021 (NDA)
FDA decision on LPCN 1021 for testosterone replacement therapy in adult males
06/04/2016
Adamis Pharmaceuticals Corp
Epinephrine Pre-filled Syringe (NDA Resubmission)
FDA decision on Epinephrine Pre-filled Syringe for the emergency treatment of anaphylaxis
05/29/2016
Intercept Pharmaceuticals Inc.
Obeticholic acid (NDA)
FDA decision on Obeticholic acid for treating primary biliary cirrhosis
05/27/2016
VANDA PHARMACEUTICALS
Fanapt (sNDA)
FDA decision on Fanapt as a maintenance treatment of schizophrenia in adults
05/26/2016
ZS Pharma, Inc.
ZS-9 ( NDA)
FDA decision on ZS-9 for the treatment of hyperkalemia
05/26/2016
Sarepta Therapeutics
Eteplirsen (NDA)
FDA decision on Eteplirsen for treatment of Duchenne Muscular Dystrophy
05/01/2016
ACADIA Pharmaceuticals Inc
NUPLAZID (NDA)
FDA decision on NUPLAZID for for the treatment of psychosis associated with Parkinson’s disease
04/30/2016
Flamel Technologies SA
Unapproved Marketed Drug (NDA)
FDA decision on Unapproved Marketed Drug
04/16/2016
Celgene Corporation
REVLIMID (sNDA)
FDA decision on REVLIMID for the treatment of non-del 5q lower risk myelodysplastic syndromes
04/16/2016
Valeant Pharmaceuticals International
VRX, VRX.TO
Oral Relistor (NDA)
FDA decision on Oral Relistor for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer painT
Pharma-021016.jpg The FDA has revised the partial hold imposed on CTI BioPharma Corp.'s (CTIC) clinical studies of Pacritinib, its lead drug candidate for primary myelofibrosis, on February 8, 2016, to full clinical hold.
Pharma-Report-020816.jpg Shares of BioCryst Pharmaceuticals Inc. (BCRX) cratered over 71% on Monday, following disappointing results from a 12-week, three-arm, parallel cohort design trial of orally-administered Avoralstat in patients with hereditary angioedema.
Pharma-020816.jpg The FDA has placed a partial hold on clinical studies of CTI BioPharma Corp.'s (CTIC) Pacritinib, its lead drug candidate for primary myelofibrosis, due to excess mortality and other adverse events in a pivotal trial.
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Those who experience routine concussions could be at a higher risk of suicide, according to a new study from researchers at the Institute for Clinical Evaluative Sciences and a physician at Sunnybrook Health Sciences Center in Toronto. For the study the researchers pulled health records for everyone that was diagnosed but didn't need surgery or hospitalization in the province of Ontario.
There may be a new treatment for jet lag on the way, according to a new study from researchers at the Stanford University School of Medicine. For the study the researchers collected data from 39 participants ranging in age from 19 to 36. They had each of the participants get on a sleep cycle in which they went to bed and rose at the same time every night for two weeks.
Conversion therapy, a process attempting to convert homosexuals in heterosexuality, may soon be banned in the state of New York. Thus far the scientifically unproven therapy has only been banned in California, New Jersey, Oregon and Illinois. Earlier this week New York governor Andrew Cuomo announced plans to ban the process within the state.
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