By Elias Schisgall

Beam Therapeutics shares climbed after the company said it plans to file an application for its risto-cel treatment and had reached alignment with the Food and Drug Administration on potential accelerated approval for another treatment.

Shares rose 28% to $35.37 midday Monday. The stock has gained 34% in the past year.

The genetic-disease medicine company said late Sunday that it expects to file a biologics licensing application for risto-cel, a treatment for glycogen storage disease type Ia previously known as BEAM-301, as early as the end of 2026.

The company also said it had reached alignment with the FDA on an accelerated approval pathway for BEAM-302, a therapy for alpha-1 antitrypsin deficiency. It said approval depended on alpha-1 antitrypsin biomarkers over the next 12 months, adding that it was expanding its ongoing Phase 1/2 study of the drug.

Beam said it expects to report updated data from that trial by the end of the first quarter, adding that both drug candidates have been accepted into the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

January 12, 2026 12:05 ET (17:05 GMT)

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