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
Amgen Inc.
Talimogene laherparepvec (NDA)
FDA decision on Talimogene laherparepvec 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
Relypsa Inc
Patiromer for Oral Suspension (NDA)
FDA decision on Patiromer for the treatment of hyperkalemia
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for the treatment of patients with advanced non-small cell lung cancer
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
Oral Rolapitant (NDA)
FDA decision on oral Rolapitant for the prevention of chemotherapy-induced nausea and vomiting
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
Amgen Inc.
Repatha (BLA)
FDA decision on Repatha for the treatment of high cholesterol
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma.
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
Seattle Genetics Inc.
FDA decision on ADCETRIS in AETHERA setting for post-transplant consolidation treatment of Hodgkin lymphoma patients
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
Mid Aug 2015
Novartis AG
LCZ696 (NDA)
FDA decision on LCZ696 for the treatment of heart failure with reduced ejection fraction
Aug 2015
Novartis AG
LCZ696 (NDA)
FDA decision on LCZ696 for the treatment of heart failure with reduced ejection fraction
FDA approved LCZ696 now called Entresto for the treatment of heart failure with reduced ejection fraction on July 7, 2015
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA decision on Talimogene Laherparepvec in combination with Keytruda for advanced melanoma
Pharma01-073015.jpg Shares of Ascendis Pharma A/S (ASND) touched a new high on Thursday, following the company's positive top-line results from a six-month phase II study of once-weekly TransCon Growth Hormone in 53 treatment-naïve, pre-pubertal children with growth hormone deficiency, or GHD.
AscendisPharma-073015.jpg Ascendis Pharma A/S (ASND) is scheduled to report top-line results from a phase II pediatric study of TransCon hGH before the market opens today.
Pharma0-072815.jpg Shares of AtriCure Inc. (ATRC) were up more than 5% in extended trading on Tuesday after the company, which reported solid results for the second quarter, boosted its revenue outlook for 2015.
A panel of medical experts suggest that adults should be screened for depression by their primary care physician. The proposal will be open for public comment until August 24. The U.S. Preventive Services Task Force recommend that adults be screened in doctors' offices if staff-assisted depression care is available.
The use of less-than-perfect vaccines, or "leaky" vaccines, can lead to evolution of more deadly versions of a virus, researchers have confirmed. The findings, which appeared in the journal PLoS Biology, featured scientific experiments with the herpes virus such as the one that causes Marek's disease in poultry, show that some vaccines could allow more-virulent versions of a virus to survive.
Young children who suffer from glue ear, a middle-ear problem that can affect hearing development, can be treated simply by blowing up a balloon through a nostril, a new study shows. Researchers studied 320 children aged four to 11 who had recent histories of otitis media with effusion, and confirmed fluid in one or both ears.
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