FDA Calendar

PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks.

The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date.

Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. So, having prior knowledge of the key dates goes a long way toward maximizing profit or minimizing loss while investing in the 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 RTT Biotech Investor and our Biotech Home Page.
Company Name
Lantheus Holdings Inc.
FDA decision on PyL , an imaging agent for prostate cancer
Eton Pharmaceuticals, Inc
Zonisamide oral suspension (NDA)
FDA decision on Zonisamide for the treatment of partial seizures in patients with epilepsy
Bristol-Myers Squibb Co.
Zeposia (sNDA)
FDA decision on Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC)
Kadmon Holdings LLC
Belumosudil (NDA)
FDA decision on Belumosudil for the treatment of patients with chronic graft-versus-host disease
On Mar.9, 2021, the company announced that the FDA decision date has been extended to August 30, 2021-
Myovant Sciences Ltd
Relugolix (NDA)
FDA decision on Relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids
Oral Ibrexafungerp (FDA)
FDA decision on Oral Ibrexafungerp for for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infections
Alkermes plc
ALKS 3831 (Resubmission NDA)
FDA decision on ALKS 3831 for the treatment of adults with schizophrenia and adults with bipolar I disorder
Iterum Therapeutics plc
Oral sulopenem (NDA)
FDA panel to review Oral sulopenem for the treatment of uncomplicated urinary tract infections
On Apr.8, 2021, the company was notified by the FDA that it needs more time to review the NDA as a result of which it is postponing the Panel review-
Liminal BioSciences Inc.
Ryplazim (Resubmitted BLA)
FDA decision on Ryplazim for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency
Biogen Inc.
Aducanumab (BLA)
FDA decision on Aducanumab for the treatment of Alzheimer’s disease

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