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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
Cingulate Inc.
(CING)
CTx-1301 (NDA)
05/31/2026
FDA decision on CTx-1301 for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adults
FDA issued a Complete Response Letter for CTx-1301 for the
treatment of Attention Deficit/Hyperactivity Disorder (ADHD) on June 2, 2026.
-
Daiichi Sankyo Company Limited
( DSKYF, 4568.T)
DATROWAY (sBLA)
06/02/2026
FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy
FDA approved DATROWAY for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for immunotherapy on May 22, 2026-
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
DATROWAY (sBLA)
06/02/2026
FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy
FDA approved DATROWAY for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for immunotherapy on May 22, 2026-
Arvinas, Inc.
(ARVN)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
FDA approved vepdegestrant, under the brand name VEPPANU, for the treatment of ESR1m, ER+/HER2- advanced breast cancer on May 1, 2026-
Pfizer Inc.
(PFE)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
FDA approved Vepdegestrant, under the brand name VEPPANU, for the treatment of ESR1m, ER+/HER2- advanced breast cancer on May 1, 2026-
Rigel Pharmaceuticals Inc.
(RIGL)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
FDA approved vepdegestrant, under the brand name VEPPANU, for the treatment of ESR1m, ER+/HER2- advanced breast cancer on May 1, 2026-
Camurus AB
(CAMX.ST)
Oclaiz (resubmitted NDA)
06/10/2026
FDA decision on Oclaiz for the treatment of patients with acromegaly
Pending-
GSK plc
( GSK, GSK.L, GS71.DE)
Tebipenem HBr (NDA)
06/18/2026
FDA decision on tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis
pending-
Spero Therapeutics, Inc.
(SPRO)
Tebipenem HBr (NDA)
06/18/2026
FDA decision on tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis
pending-
Regeneron Pharmaceuticals Inc
(REGN)
ARCALYST (sBLA)
06/19/2026
FDA decision regarding the technology transfer to Samsung Biologics Co., Ltd. as replacement CDMO for ARCALYST
Pending-

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