Phase 3 Win on All Endpoints Puts EPP Drug on Track for FDA Filing
IRON sits 79% above its 52-week low of $40.
Summary
Disc Medicine's pivotal Phase 3 APOLLO trial of bitopertin, its lead asset developed with Roche, hit every primary and secondary endpoint in EPP, including a 41.4% reduction in whole-blood metal-free PPIX versus placebo (p<0.0001) and a 12.2-hour monthly gain in pain-free light exposure (p=0.0010). All secondary measures, including phototoxic reaction rates and patient-reported outcomes, were also statistically significant, and the drug was generally well tolerated with no adverse events above Grade 3. This is the first EPP candidate to show both a mechanistic PPIX reduction and clear clinical benefit, and it comes after the company already flagged a prior NDA setback that now looks addressable. Disc plans to resubmit its NDA by the end of 2026, with an FDA decision expected by mid-2027. The company ended Q2 with $717.7M in cash, runway into 2029, so funding the resubmission is not a concern. Management hosts a webcast at 8:00am ET today to walk through the data and next steps.
At the time of this announcement, IRON was trading at $71.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.2B. 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 9 out of 10. Source: GlobeNewswire.