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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
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
Nabriva Therapeutics
Lefamulin (NDA)
FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
08/19/2019
Karyopharm Therapeutics Inc.
Selinexor (NDA)
FDA decision on Selinexor for patients with refractory multiple myeloma
07/06/2019
Dova Pharmaceuticals, Inc.
DOPTELET (sNDA)
FDA decision on DOPTELET for chronic immune thrombocytopenia
06/30/2019
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent for severe chronic rhinosinusitis with nasal polyps
06/26/2019
Agios Pharmaceuticals, Inc.
TIBSOVO (sNDA)
FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
06/21/2019
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
06/10/2019
Nektar Therapeutics
NKTR-181 (NDA)
FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
05/28/2019
Heron Therapeutics Inc.
HTX-011 (NDA)
FDA decision on HTX-011 for the management of postoperative pain
04/30/2019
Nabriva Therapeutics
CONTEPO (NDA)
FDA decision on CONTEPO IV for the treatment of complicated urinary tract infections
04/30/2019
Sanofi
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019
Regeneron Pharmaceuticals
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019
ADMA BIOLOGICS, INC.
RI-002 (BLA resubmission)
FDA decision on RI-002 to treat primary immune deficiency disease
04/02/2019
Evoke Pharma, Inc.
Gimoti (NDA)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
04/01/2019


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