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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
10/27/2015
Amgen Inc.
Talimogene laherparepvec (NDA)
FDA decision on Talimogene laherparepvec for advanced melanoma
10/24/2015
MERRIMACK PHARMACEUTICALS, INC.
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
10/21/2015
Relypsa Inc
Patiromer for Oral Suspension (NDA)
FDA decision on Patiromer for the treatment of hyperkalemia
10/02/2015
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for the treatment of patients with advanced non-small cell lung cancer
09/08/2015
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
09/05/2015
TESARO, Inc.
Oral Rolapitant (NDA)
FDA decision on oral Rolapitant for the prevention of chemotherapy-induced nausea and vomiting
08/27/2015
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma.
08/27/2015
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
08/27/2015
Amgen Inc.
Repatha (BLA)
FDA decision on Repatha for the treatment of high cholesterol
08/22/2015
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
08/18/2015
Seattle Genetics Inc.
ADCETRIS (sBLA)
FDA decision on ADCETRIS in AETHERA setting for post-transplant consolidation treatment of Hodgkin lymphoma patients
08/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
07/28/2015
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA decision on Talimogene Laherparepvec in combination with Keytruda for advanced melanoma
07/26/2015
Amgen Inc.
Kyprolis (sNDA)
FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
FDA approved Kyprolis for the treatment of relapsed multiple myeloma on July 24, 2015
07/24/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of patients with hypercholesterolemia
FDA approves Praluent for the treatment of patients with hypercholesterolemia
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.
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