TLDR
- FDA CRL derails bitopertin fast-track; Disc pivots to APOLLO readout.
- Disc Medicine dives 22% as FDA rejects accelerated EPP approval for bitopertin.
- FDA accepts PPIX drop, but denies link to sunlight endpoints; APOLLO is next.
- APOLLO enrollment targets March 2026; resubmission could push decision to 2027.
- Disc cites $791M cash runway to 2029, but timeline extends after CRL shock.
Disc Medicine, Inc. (IRON) stock plunges 22% after the FDA issued a Complete Response Letter for bitopertin. The decision delayed accelerated approval for erythropoietic protoporphyria, and it extended the program timeline into 2027. Meanwhile, the shares closed at $55.95, down 21.91%, and after-hours stayed volatile near $55.53.
FDA CRL disrupts accelerated approval path for bitopertin in EPP
Disc Medicine, Inc. stock plunges 22% after the agency rejected accelerated approval for bitopertin in EPP. The FDA accepted evidence that AURORA and BEACON lowered metal-free protoporphyrin IX in whole blood. The FDA did not accept the biomarker as predictive for sunlight exposure outcomes measured in those trials.
The FDA based its decision on the missing association between PPIX reduction and sunlight exposure-based endpoints. Therefore, the CRL focused on the surrogate endpoint standard required for accelerated approval. The FDA indicated APOLLO results could support traditional approval for bitopertin.
Disc Medicine, Inc. stock plunges 22% after the market repriced the timeline and probability of near-term approval. The stock saw a sharp mid-day breakdown, and then it bounced after touching a low near $45. Still, the session ended with heavy losses, and after-hours trading showed continued weakness.
Company plans Type A FDA meeting and targets APOLLO enrollment by March 2026
Disc Medicine, Inc. stock plunges 22% after the company confirmed it will request a Type A FDA meeting. The company plans to align on a response strategy, and it aims to resolve the CRL requirements. As a result, Disc expects APOLLO to carry the evidence package for a resubmission.
The company reported that APOLLO remains well underway, with topline data expected in Q4. Disc completed a blinded sample size re-estimation in January and kept enrollment targets unchanged. The company also expects to finish APOLLO enrollment in March 2026, earlier than prior planning.
Disc Medicine, Inc. stock plunges 22% after management reaffirmed its approval pathway now depends on APOLLO. After APOLLO ends, Disc plans to file a CRL response and then seek a new FDA decision by mid-2027. The program shifts from an expedited route to a traditional approval framework.
Cash position supports extended timeline as Disc schedules February 17 investor call
Disc Medicine, Inc. stock plunges 22% after the delay reset near-term expectations for commercialization timing. Even so, the company reported about $791 million in unaudited cash and marketable securities as of December 31, 2025. Disc kept guidance that its capital runway extends into 2029.
Disc Medicine, Inc. stock plunges 22% after the CRL added more development and regulatory work. Yet the company positioned the issue as addressable, because APOLLO already operates and enrollment progresses. Also, Disc pointed to strong site engagement and patient participation as operational support for the trial timeline.
Disc Medicine, Inc. stock plunges 22% as the company prepares an investor call at 8 a.m. ET on February 17. Disc will discuss the FDA outcome, and it will outline next steps tied to APOLLO and resubmission timing. The company plans to file a Form 8-K that includes the CRL for public access.
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