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
Bristol-Myers Squibb Co.
Lisocabtagene maraleucel (BLA)
FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
11/16/2020
Alkermes plc
ALKS 3831 (NDA)
FDA decision on ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder
11/15/2020
Amgen Inc.
KYPROLIS (sNDA)
FDA decision on KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma
11/15/2020
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
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
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
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
Mesoblast Limited
Ryoncil (BLA)
FDA decision on Ryoncil for the treatment of children with steroid-refractory acute graft versus host disease
09/30/2020
Aquestive Therapeutics Inc.
Libervant Buccal Film (NDA)
FDA decision on Libervant Buccal Film for management of seizure clusters
09/27/2020
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