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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
Sutimlimab (BLA)
FDA decision on Sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease
11/13/2020
Supernus Pharmaceuticals, Inc.
SPN-812 (NDA)
FDA decision on SPN-812 for the treatment of ADHD
11/08/2020
Kala Pharmaceuticals, Inc.
EYSUVIS 0.25% (Resubmitted NDA)
FDA decision on EYSUVIS 0.25% for Dry Eye Disease
10/30/2020
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma
10/30/2020
Regeneron Pharmaceuticals
REGN-EB3 (BLA)
FDA decision on REGN-EB3 for Ebola virus infection
10/25/2020
Spectrum Pharmaceuticals Inc
ROLONTIS (BLA)
FDA decision on ROLONTIS for the treatment of chemotherapy-induced neutropenia
10/24/2020
Zosano Pharma Corporation
Qtrypta (NDA)
FDA decision on Qtrypta for the acute treatment of Migraine
10/20/2020
Halozyme Therapeutics, Inc.
Perjeta And Herceptin Using Enhanze Technology (BLA)
FDA decision on subcutaneous combination of Perjeta and Herceptin Using Enhanze Technology for breast cancer
10/18/2020
Roche Holding AG
Perjeta and Herceptin.Using Enhanze Technology (BLA)
FDA decision on subcutaneous combination of Perjeta and Herceptin Using Enhanze Technology for breast cancer
10/18/2020
FDA approved Phesgo (Perjeta and Herceptin) on July 29, 2020
Roche Holding AG
Fixed-dose subcutaneous combination of Perjeta and Herceptin (BLA)
FDA decision on combination of Perjeta and Herceptin for HER2-positive breast cancer
10/18/2020
Alexion Pharmaceuticals Inc.
ULTOMIRIS 100mg/mL (NDA)
FDA decision on ULTOMIRIS (ravulizumab) in atypical hemolytic uremic syndrome (aHUS)
10/11/2020
Fortress Biotech Inc.
IV Tramadol (NDA)
FDA decision on IV Tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting
10/10/2020
Avenue Therapeutics, Inc.
IV Tramadol (NDA)
FDA decision on IV Tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting
10/10/2020
Avenue Therapeutics, Inc.
Intravenous tramadol (NDA)
FDA decision on IV tramadol for severe pain in adults following abdominoplasty surgery
10/10/2020
Mesoblast Limited
Ryoncil (BLA)
FDA decision on Ryoncil for the treatment of children with steroid-refractory acute graft versus host disease
09/30/2020

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