logo

FDA Calendar

Share
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.

Get in-depth analysis and insight on investing in the high-stakes biotech and pharma sectors. Check out our premium biotech research product and our biotech home page.
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

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

Buy this Content


uscoronavirus april20 24may20 As the companies race against time to develop antibiotics or vaccines against the novel coronavirus, here's what happened in the COVID-19 drug/vaccine development space in the week that went by.
pharma 032717 21may20 Today's Daily Dose brings you news about the near-term catalyst of Atara; promising lab study results of Atossa's COVID-19 med; the progress in Gilead/Galapagos' ulcerative colitis trial; the timeline of Inovio's COVID-19 vaccine and the progress in Vaxart's COVID-19 vaccine program.
europeanstock1 dec16 20may20 Inovio Pharmaceuticals Inc. (INO), one of the key players in the race to develop a COVID-19 vaccine, has revealed promising data from a preclinical study of INO-4800, its DNA vaccine candidate against the novel coronavirus SARS-CoV-2, which causes COVID-19.
Read More
Coronavirus infection rate rose for the third consecutive day in the United States. With more than 25000 new cases reporting in the last 24 hours, the total number of infections in the country rose to 1,577,758 as of John Hopkins University' 6:00 a.m. ET update Friday. With an additional 1286 deaths, the total death toll in the U.S. reached 94729. In New York, more than 356,000 cases have been
Canadian cannabis company Aurora Cannabis Inc. has announced its entry into the lucrative U.S. market with its acquisition of Massachusetts-based Reliva LLC, a seller of hemp-derived cannabidiol or CBD products. Under the terms of the deal, Aurora will pay about $40 million of its common shares to...
After the World Health Organization reported the most number of new coronavirus cases recorded in a 24-hour period during the pandemic, global cases crossed the 5 million mark on Thursday. As more European countries and the United States started easing lockdowns, a total of 5,011,467 million cases of Covid-19 have been reported worldwide.
Read More