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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
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
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
Aerie Pharmaceuticals, Inc.
Roclatan (NDA)
FDA decision on Roclatan for patients with open-angle glaucoma, retina diseases
03/14/2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in Combination with Abraxane for Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
03/12/2019
Novo Nordisk A/S
N8-GP (BLA)
FDA decision on N8-GP for treatment of people with haemophilia A
02/27/2019
Bausch Health Companies Inc.
BHC, BHC.TO
Loteprednol etabonate ophthalmic gel (NDA)
FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
02/25/2019
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD
02/24/2019


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