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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
argenx SE
( ARGX, ARGX.BR)
VYVGART (sBLA)
05/10/2026
FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative).
FDA approved label expansion for VYVGART and VYVGART Hytrulo to include all serotypes of adult patients living with generalized myasthenia gravis on May 8, 2026-
Daiichi Sankyo Company Limited
( DSKYF, 4568.T)
ENHERTU (sBLA)
05/18/2026
FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer
FDA approved ENHERTU in the neoadjuvant and adjuvant settings of patients with HER2-positive early breast cancer on May 16, 2026-
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
ENHERTU (sBLA)
05/18/2026
FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer
FDA approved ENHERTU in the neoadjuvant and adjuvant settings of patients with HER2 positive early breast cancer on May 16, 2026-
Eisai Co Ltd
(ESALY.PK, ESALF.PK, 4523.T, EII.SG)
LEQEMBI IQLIK (sBLA)
05/24/2026
FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
FDA requests additional information during the review process of LEQEMBI IQLIK and extends the decision by three months to Aug 24, 2026-
Biogen Inc.
(BIIB)
LEQEMBI IQLIK (sBLA)
05/24/2026
FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
FDA requests additional information during the review process of LEQEMBI IQLIK and extends decision by three months to Aug 24-
BioArctic AB
( BRCTF, BIOA-B.ST, BIOA_B.ST)
Leqembi Iqlik subcutaneous autoinjector (sBLA)
05/24/2026
FDA decision on Leqembi Iqlik Subcutaneous Autoinjector for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease
FDA requests additional information during the review process of LEQEMBI IQLIK and extends the decision by three months to Aug 24, 2026-
MannKind Corp.
(MNKD)
Afrezza (sBLA)
05/29/2026
FDA decision on Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes
FDA approved Afrezza Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes on May 29, 2026-
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-

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