By Chris Wack
Disc Medicine shares were rose after the company said it received positive feedback from its end-of-Phase 2 meeting with the Food and Drug Administration, supporting the regulatory path forward for bitopertin in erythropoietic protoporphyria.
Shares were up 27% to $59.68 in recent trading. The stock has risen about 25% in the last 12 months.
The clinical-stage biopharmaceutical company said the meeting resulted in agreement on all proposed attributes of its Phase 2 study, which the company plans to initiate by mid-2025.
The Watertown, Mass., company said the agreement on attributes on the study includes the sufficiency of a single, randomized, double-blind, placebo-controlled trial, and the primary endpoint of average monthly total time in sunlight without pain during the last month following six months of treatment.
Disc now has the potential to submit a new drug application based on its existing data package, and the Phase 2 trial would serve as a confirmatory trial.
Disc will be meeting with the FDA to finalize the details of the trial, and plans to provide an update in the first quarter of 2025, as well as timing for NDA filing under an accelerated pathway.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 04, 2024 13:32 ET (18:32 GMT)
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