Common Stock, par value $0.0001 per share
- Symbol
- IRON
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
IRONNASDAQEQUITYCurrent
Item 7.01 Regulation FD Disclosure. On October 19, 2026, Disc Medicine, Inc. (the “Company”) issued a press release titled “Disc Medicine Announces Success on All Primary and Secondary Endpoints in the Pivotal Phase 3 APOLLO Trial of Bitopertin in Adults and Adolescents with Erythropoietic Protoporphyria (EPP).” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.…
Disc Medicine (NASDAQ: IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.
Disc Medicine, Inc. · 8-K · Filed 2026-10-19
Exhibit 99.1 Disc Medicine Announces Success on All Primary and Secondary Endpoints in the Pivotal Phase 3 APOLLO Trial of Bitopertin in Adults and Adolescents with Erythropoietic Protoporphyria (EPP) Positive APOLLO trial topline results demonstrated statistically significant and clinically meaningful benefit across all study endpoints Successfully met co-primary endpoints of reduction in protoporphyrin IX (PPIX) and increased total time in light ─────────────────────────────────────────────────────────────────────────── All secondary endpoint results were also positive and statistically significant, including reductions in phototoxic reactions and improvements on multiple measures of light tolerance Exploratory endpoints of quality-of-life improvement were also statistically significant Bitopertin was generally well-tolerated with no new safety signals observed in APOLLO Disc plans to resubmit an NDA to FDA by end of 2026, with an FDA decision anticipated by mid-2027 ───────────────────────────────────────────────────────────────────────────────────────────────────── Disc to discuss topline results in a corporate webcast on October 19, 2026 at 8:00am…
Open exhibit ↗APOLLO Topline Results October 19, 2026 Exhibit 99.2 Disclaimer and FLS This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to its preclinical studies, clinical trials and research and development programs, in particular with respect to bitopertin, selcodebart (DISC-0974) and DISC-3405, and any developments or results in connection therewith; projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical and commercial readiness activities; the registrational pathway for bitopertin, including the projected timeline for an NDA resubmission and the timing of an FDA decision; anticipated discussions with regulatory agencies; Disc’s expectations with respect to the potential launch and commercialization of bitopertin, if approved; the potential therapeutic benefits of bitopertin as a treatment for EPP, if approved; the market and potential opportunities for bitopertin, selcodebart and DISC-3405; the potential of Disc’s development p…
Open exhibit ↗