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
FDA approved PyL, under brand name PYLARIFY, on May 27, 2021-
Eton Pharmaceuticals, Inc
Zonisamide oral suspension (NDA)
FDA decision on Zonisamide for the treatment of partial seizures in patients with epilepsy
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-
Bristol-Myers Squibb Co.
Zeposia (sNDA)
FDA decision on Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC)
FDA approved Zeposia for the treatment of adults with moderately to severely active ulcerative colitis on May 27, 2021-
Alkermes plc
ALKS 3831 (Resubmitted NDA)
FDA decision on ALKS 3831 for the treatment of adults with schizophrenia and adults with bipolar I disorder
FDA approved ALKS 3831, under brand name LYBALVI, for the treatment of schizophrenia and bipolar I disorder on Jun.1, 2021-
Myovant Sciences Ltd
Relugolix (NDA)
FDA decision on Relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids
FDA approved Relugolix combination tablet, under brand name MYFEMBREE, for women with heavy menstrual bleeding associated with uterine fibroids on May 26, 2021-
Oral Ibrexafungerp (FDA)
FDA decision on Oral Brexafemme (Ibrexafungerp) for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infections
FDA approved Ibrexafungerp, under brand name BREXAFEMME, on June 2, 2021,for the treatment of vulvovaginal candidiasis -
BridgeBio Pharma, Inc.
Infigratinib (NDA)
FDA decision on Infigratinib to treat patients with cholangiocarcinoma
FDA granted accelerated approval to Infigratinib , under brand name TRUSELTIQ for patients with cholangiocarcinoma on May 28, 2021-
Pfizer Inc.
20-valent pneumococcal conjugate vaccine (BLA)
Jun 2021
FDA decision on 20-valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in aults
FDA approved 20-valent pneumococcal conjugate vaccine, under brand name Prevnar 20, on Jun.8, 2021-
Iterum Therapeutics plc
Oral sulopenem (NDA)
FDA panel to review Oral sulopenem for the treatment of uncomplicated urinary tract infections
On May 27, 2021, the company was notified that the FDA has determined that an Advisory Committee meeting is not currently necessary-

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