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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
Clearside Biomedical, Inc.
XIPERE (NDA)
FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
10/19/2019
Flexion Therapeutics, Inc.
ZILRETTA (sNDA)
FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
10/14/2019
Amarin Corp Plc
Vascepa (sNDA)
FDA decision on Vascepa to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol
09/28/2019
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
09/27/2019
AVADEL PHARMACEUTICALS PLC
AV001 (NDA)
FDA decision on AV001 for Hospital product
09/15/2019
Aimmune Therapeutics Inc.
AR101 (BLA)
FDA panel to review AR101 for Peanut Allergy
09/13/2019
Celgene Corporation
Fedratinib (NDA)
FDA decision on Fedratinib for myelofibrosis
09/03/2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
09/02/2019
Daiichi Sankyo Company Limited
DSKYF.PK
Quizartinib (NDA)
FDA decision on Quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia
08/25/2019
Nabriva Therapeutics
Lefamulin (NDA)
FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
08/19/2019
VANDA PHARMACEUTICALS
HETLIOZ (sNDA)
FDA decision on HETLIOZ for the expanded indication of jet lag disorder
08/16/2019
Daiichi Sankyo Company Limited
DSKYF.PK
Pexidartinib (NDA)
FDA decision on Pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor
08/03/2019
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA panel to review Lumateperone for the treatment of schizophrenia in adults
07/31/2019
Celgene Corporation
OTEZLA (sNDA)
FDA decision on OTEZLA to treat Beh?et’s disease
07/21/2019
Merck & Co Inc.
Combination of Imipenem/Cilastatin and Relebactam(NDA)
FDA decision on the Imipenem/Cilastatin and Relebactam combo for the treatment of cUTI and cIAI
07/16/2019


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