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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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Company Name
Ticker
Drug
Event
Date
Outcome
Details
Sanofi
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
Akcea Therapeutics Inc.
Inotersen (NDA)
FDA decision on Tegsedi (Inotersen) for hereditary TTR amyloidosis (hATTR)
10/06/2018
IONIS PHARMACEUTICALS INC
Inotersen (NDA)
FDA decision on Tegsedi (Inotersen) for hereditary TTR amyloidosis (hATTR)
10/06/2018
Verastem, Inc.
Duvelisib (NDA)
FDA decision on Duvelisib for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
10/05/2018
Acorda Therapeutics Inc.
INBRIJA (NDA)
FDA decision on INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
10/05/2018
Roche Holding AG
HEMLIBRA (sBLA)
FDA decision on HEMLIBRA (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors
10/04/2018
Antares Pharma Inc.
XYOSTED injection(Resubmitted NDA)
FDA decision on XYOSTED injection for adult men with testosterone deficiency
09/29/2018
Insmed Inc
ALIS (Amikacin Liposome Inhalation Suspension) (NDA)
FDA decision on ALIS for adult patients with nontuberculous mycobacterial lung disease
09/28/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda in combination with ALIMTA and platinum chemotherapy (carboplatin or cisplatin) for metastatic nonsquamous non-small cell lung cancer
09/23/2018
Teva Pharmaceutical Industries Limited
Fremanezumab (BLA)
FDA decision on Fremanezumab for the treatment of migraine
09/16/2018
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ in combination with Avastin or bevacizumab, paclitaxel and carboplatin or chemotherapy for initial treatment of people with metastatic NSCLC
09/05/2018
Adamis Pharmaceuticals Corp
Symjepi (sNDA)
FDA decision on low dose Symjepi (0.15mg) for the emergency treatment of anaphylaxis
09/03/2018
Akcea Therapeutics Inc.
Volanesorsen (NDA)
FDA decision on Volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
08/30/2018
Tetraphase Pharmaceuticals
Eravacycline (NDA)
FDA decision on Eravacycline for the treatment of complicated intra-abdominal infections
08/28/2018
Merck & Co Inc.
Lenvatinib (sNDA)
FDA decision on Lenvima for the potential first-line treatment of patients with unresectable hepatocellular carcinoma
08/24/2018
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