FDA Action Alert: Upcoming Decisions on Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai, and Cingulate

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The FDA is reviewing label expansions for several biopharma companies in May 2026, with target action dates including May 10 for Argenx's Vyvgart14.

Argenx seeks to expand Vyvgart label to acetylcholine receptor antibody-negative generalized myasthenia gravis patients, supported by Phase 3 ADAPT SERON study data; decision by May 101.

AstraZeneca/Daiichi Sankyo's Enhertu sBLA for neoadjuvant/adjuvant treatment in high-risk HER2-positive early breast cancer has a target action date of May 18, backed by Phase 3 DESTINY-Breast11 study showing 67.3% pathologic complete response1.

Biogen/Eisai propose subcutaneous Leqembi for treatment initiation in Alzheimer's, following prior maintenance approval; FDA decision expected by May 24, supported by Phase 3 Clarity AD sub-studies1.

Cingulate's CTx-1301, a novel ADHD formulation, is under 505(b)(2) review with Phase 3 data showing symptom relief and safety in pediatric/adult patients1.

Sources:

1. https://www.biospace.com/fda/fda-action-alert-argenx-astrazeneca-daiichi-sankyo-biogen-eisai-and-cingulate

4. https://conexiant.com/neurology/articles/fda-monthly-preview-key-may-decisions-to-watch/