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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
Takeda Pharmaceutical Company Limited
( TAK, TKPHF, 4502.T)
Oveporexton (TAK-861) (NDA)
Q3 2026
FDA decision on Oveporexton for the treatment of Narcolepsy Type 1
pending-
Takeda Pharmaceutical Company Limited
( TAK, TKPHF, 4502.T)
Rusfertide (NDA)
Q3 2026
FDA decision on Rusfertide To Treat Polycythemia Vera in adults
pending-
Roivant Sciences Ltd.
(ROIV)
Brepocitinib (NDA)
Q3 2026
FDA decision on brepocitinib for the treatment of dermatomyositis
pending-
Merck & Co Inc.
(MRK)
KEYTRUDA plus Trodelvy (sBLA)
2H 2026
FDA decision on KEYTRUDA plus Trodelvy for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC
Pending-
Merck & Co Inc.
(MRK)
KEYTRUDA QLEX plus Trodelvy (sBLA)
2H 2026
FDA decision on KEYTRUDA QLEX plus Trodelvy for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC
Pending-
Vera Therapeutics, Inc.
(VERA)
Atacicept (BLA)
07/07/2026
FDA decision on atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN)
pending-
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
ENHERTU(sBLA)
07/07/2026
FDA decision on ENHERTU as post-neoadjuvant treatment for patients with HER2-positive early breast cancer
pending-
Daiichi Sankyo Company Limited
( DSKYF, 4568.T)
ENHERTU(sBLA)
07/07/2026
FDA decision on ENHERTU as post-neoadjuvant treatment for patients with HER2-positive early breast cancer
pending-
Corcept Therapeutics Inc
(CORT)
Relacorilant (NDA)
07/11/2026
FDA decision on Relacorilant as a treatment for patients with platinum-resistant ovarian cancer
FDA approved Relacorilant, under the brand name Lifyorli, as a treatment for patients with platinum-resistant ovarian cancer on Mar.25, 2026-
Celcuity Inc.
(CELC)
Gedatolisib (NDA)
07/17/2026
FDA decision on gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer
Pending-

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