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
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo to treat patients with previously treated non-squamous NSCLC
FDA approved Opdivo to treat patients with previously treated non-squamous NSCLC on Oct.9, 2015, nearly 3 months of the decision date
Biomarin Pharmaceutical Inc.
Drisapersen (NDA)
FDA decision on Drisapersen for the treatment of Duchenne Muscular Dystrophy amenable to Exon 51 skipping
Teva Pharmaceutical Industries Limited
Reslizumab (BLA)
FDA panel to review Reslizumab for the treatment of inadequately controlled asthma in adult and adolescent patient
Alexion Pharmaceuticals Inc.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
Repros Therapeutics Inc.
Enclomiphene (formerly Androxal) (NDA)
FDA decision on Enclomiphene for secondary hypogonadism in overweight men
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
Roche Holding AG
Cobimetinib (NDA)
FDA decision on Cobimetinib for advanced melanoma
Neos Therapeutics, Inc.
Cotempla XR-ODT (NDA)
FDA decision on Cotempla XR-ODT for the treatment of ADHD
Merck & Co Inc.
Sugammadex sodium injection (NDA)
FDA panel to review Sugammadex sodium for reversal of moderate or deep neuromuscular blockade
GlaxoSmithKline PLC
Mepolizumab (BLA)
FDA decision on Mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.
Repros Therapeutics Inc.
Enclomiphene (formerly Androxal) (NDA)
FDA panel to review Enclomiphene for secondary hypogonadism in overweight men
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA decision on Talimogene Laherparepvec in combination with Keytruda for advanced melanoma
MM-398 (NDA)
FDA decision on MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
AstraZeneca PLC
Lesinurad oral tablets (NDA)
FDA panel to review Lesinurad for the treatment of hyperuricemia associated with gout,
Pharma-101215.jpg With the FDA not being able to complete the review of Collegium Pharmaceutical Inc.'s (COLL) New Drug Application for Xtampza ER in time, it's going to be another anxious wait for the investors.
Pharma-101115.jpg Amgen's (AMGN) injectable osteoporosis drug Prolia scored over the most-frequently used intravenous bisphosphonate zoledronic acid in improving bone mineral density in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates in a phase 4 study.
PharmaDaily-100915.jpg Verastem Inc. is reducing its workforce by approximately 50% to 20 full time employees. The company suffered a blow on September 28, 2015, with the stock losing 67% of its value, following an enrollment halt to a phase II study of its lead drug candidate VS-6063 for patients with mesothelioma due to futility.
A new test may be able to help predict if some teens are at an increased risk for cardiovascular ailments, according to a new study from researchers at the University of Virginia School of Pediatrics and the West Virginia University's School of Public Health. The new test makes analyses the risk of metabolic syndrome, which include symptoms like increased blood pressure.
Hospitals in the U.S. are now providing greater support to breastfeeding mothers than ever before, according to a new study from researchers at the Centers for Disease Control and Prevention. For the study the CDC reviewed data on the number of hospitals nationwide using the Ten Steps to Successful Breastfeeding system, which is a global standard for breastfeeding support.
A very sensitive new blood test may help rule out the risk of heart attacks, according to a new study from researchers at University of Edinburgh in Scotland. The test will be aimed at those seeking emergency room care for symptoms resembling heart attacks. The test can detect even slight levels of a protein called troponin.
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