Disc Medicine Jumps 35% as Phase 3 Win Revives Bitopertin FDA Path
IRON sits 98% above its 52-week low of $40 on elevated volume (9.1× avg).
Summary
Disc Medicine's pivotal Phase 3 APOLLO trial of bitopertin hit its primary and secondary endpoints, and the company now plans to resubmit its NDA by year-end with an FDA decision expected mid-2027. The drug cut PPIX levels by nearly 46% versus 4.4% for placebo, and patients on bitopertin logged 41.4 pain-free sunlight hours at six months versus 28.9 on placebo — the clinical-benefit link the FDA said was missing when it rejected the earlier accelerated-approval application in February. Shares jumped 35% to $76.96, the biggest single-day gain since December 2022. Cantor Fitzgerald's Kristen Kluska raised her probability-of-success model to 95% from 75% and expects the data to support a traditional approval. This is the company's lead asset, licensed from Roche in 2021, and approval would give Disc its first commercial product; the $718M cash pile from the Q2 report funds the company into 2029, so there is no near-term financing overhang. Watch the NDA resubmission by year-end and the mid-2027 FDA decision date.
At the time of this announcement, IRON was trading at $79.26 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3B. The 52-week trading range was $40.00 to $99.50. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.