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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
Nabriva Therapeutics
CONTEPO (NDA)
FDA decision on CONTEPO IV for the treatment of complicated urinary tract infections
06/30/2019
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
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
Recro Pharma Inc.
Resubmitted IV Meloxicam (NDA)
FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
03/24/2019
Lexicon Pharmaceuticals Inc.
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
Sanofi
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
03/20/2019
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
03/19/2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in combination with Chemotherapy for the initial treatment of extensive-stage small cell lung cancer
03/18/2019


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