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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
Drug
Event
Outcome
Details
Alkermes plc
(ALKS)
ALKS 3831 (Resubmitted NDA)
06/01/2021
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
(MYOV)
Relugolix (NDA)
06/01/2021
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-
SCYNEXIS, Inc.
(SCYX)
Oral Ibrexafungerp (FDA)
06/01/2021
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 -
Pfizer Inc.
(PFE)
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
(ITRM)
Oral sulopenem (NDA)
06/02/2021
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-
Liminal BioSciences Inc.
(LMNL)
Ryplazim (Resubmitted BLA)
06/05/2021
FDA decision on Ryplazim for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency
FDA approved Ryplazim for the treatment of patients with plasminogen deficiency type 1 on Jun.4, 2021-
Biogen Inc.
(BIIB)
Aducanumab (BLA)
06/07/2021
FDA decision on Aducanumab for the treatment of Alzheimer’s disease
FDA approved Aducanumab, under the brand name Aduhelm for the treatment of Alzheimer’s disease on Jun.7, 2021-
Vertex Pharmaceuticals Inc.
(VRTX)
TRIKAFTA(sNDA)
06/08/2021
FDA decision on TRIKAFTA in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
FDA Approves TRIKAFTA In Children With Cystic Fibrosis Ages 6 Thro 11 With Certain Mutations on June 9, 2021-
Royalty Pharma plc
(RPRX)
TRIKAFTA(sNDA)
06/08/2021
FDA decision on TRIKAFTA in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
FDA approved TRIKAFTA in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations on Jun.9, 2021-
Takeda Pharmaceutical Company Limited
(TKPHF.PK, TAK)
TAK-721 (NDA)
06/15/2021
FDA decision on TAK-721 for the treatment of eosinophilic esophagitis
-

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