Disc Medicine Surges 60% After Bitopertin Hits All Phase 3 APOLLO Endpoints in Rare Sun-Sensitivity Disease

Disc Medicine shares surged as much as 63% on October 19 after the company announced that its investigational drug bitopertin met all primary and secondary endpoints in the pivotal Phase 3 APOLLO trial for erythropoietic protoporphyria, a rare disorder in which sunlight exposure triggers severe pain. The stock had already climbed roughly 32% earlier in the session as investors anticipated the data readout, with the confirmed trial win driving a second leg higher. BMO also raised its price target on the stock following the announcement.

The APOLLO trial enrolled 183 adults and adolescents aged 12 and older with EPP or the related condition X-linked protoporphyria across sites in the United States, Canada, Europe, and Australia. Participants were randomized 1:1 to receive 60 mg of oral bitopertin once daily or placebo for six months. The trial met two co-primary endpoints: a 41.4% reduction in whole-blood metal-free protoporphyrin IX from baseline versus placebo (p less than 0.0001), and an increase of 12.2 hours in average monthly total time in light without pain during month 6 versus placebo (p equals 0.0010).

Bitopertin was developed in collaboration with Roche. Disc Medicine said it plans to resubmit its New Drug Application to the FDA by the end of 2026, with an agency decision anticipated by mid-2027.