Every 8-K that Disc Medicine, Inc. (IRON) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow IRON and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full IRON filings page.
Disc Medicine, Inc. (IRON) reported initial Phase 2 RESTORE-PV trial results for its investigational anti-TMPRSS6 antibody DISC-3405 in adults with polycythemia vera. The 40‑patient, multi-center, open-label study includes two cohorts receiving 300 mg subcutaneous dosing every 2 weeks (Cohort A) or every 4 weeks (Cohort B) after dose escalation.
In Cohort A, pharmacodynamic data showed dose-proportional exposure, increased hepcidin, reduced serum iron, and increased ferritin, with mean hematocrit maintained below 45% through week 26 and initial improvement in symptom burden. Among 13 Cohort A patients completing 26 weeks, mean total phlebotomy events fell from 4.0 to 0.6 over 26 weeks (p<0.0001), with 61.5% remaining phlebotomy-free; 77.8% of those completing weeks 12–32 were phlebotomy-free in that period.
Across Cohorts A and B, DISC-3405 was generally described as well-tolerated, with adverse events consistent with underlying disease and mild, self-limited injection site reactions. Disc plans to provide a further RESTORE-PV update and initial Phase 1b DISC-3405 sickle cell disease data, and to share FDA feedback and pivotal plans for selcodebart in anemia of myelofibrosis, by the end of 2026.
Disc Medicine reported second-quarter 2026 results and highlighted progress across its hematology pipeline. A Type A meeting with the FDA confirmed that the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria can, if successful, serve as the basis for a CRL response and could potentially support traditional approval, with topline APOLLO data expected in Q4 2026. The company also launched an Expanded Access Program for bitopertin and reported sustained efficacy and safety from the HELIOS extension trial.
For selcodebart (DISC-0974), updated Phase 2 RALLY-MF data in myelofibrosis showed a 56% Major anemia response rate and 72% overall anemia response rate, and the program received EU Orphan Drug Designation. Disc completed enrollment in the Phase 2 RESTORE-PV study of DISC-3405 in polycythemia vera, with initial data expected in Q3 2026, and is progressing a Phase 1b sickle cell disease study with data expected in Q4 2026.
Disc ended Q2 2026 with approximately $718 million in cash, cash equivalents, and marketable securities, which it expects to fund operations into 2029. Second-quarter research and development expenses were $46.9 million, selling, general and administrative expenses were $18.1 million, and net loss was $59.5 million, or $(1.54) per share.
Disc Medicine amended its existing Loan and Security Agreement with Hercules Capital to extend access to debt financing and adjust covenant timing. On June 25, 2026, the company agreed to immediately draw $30,000,000 from the Tranche 1-B Advance.
The prior $50,000,000 Tranche 1-C was restructured into a $25,000,000 loan available at the company’s option through March 31, 2027 and a separate $25,000,000 Tranche 1-D available through April 30, 2027. Draw periods for Tranche 2 and Tranche 3 were also extended to December 15, 2027 and June 30, 2028, respectively, and the parties set an initial testing date of July 1, 2028 for the amended minimum cash covenant.
Disc Medicine, Inc. held its 2026 annual meeting of stockholders on June 18, 2026. Stockholders elected three Class III directors — Donald Nicholson, Ph.D., John Quisel, J.D., Ph.D., and William White, M.P.P., J.D. — each for a three-year term ending at the 2029 annual meeting.
Stockholders also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers, indicating overall support for current pay practices. In addition, they ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026.
Disc Medicine, Inc. reported first quarter 2026 results showing increased investment in its hematology pipeline and a larger net loss, supported by a strong cash position. Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, expected to fund operations into 2029.
Research and development expenses rose to $45.9 million and selling, general and administrative expenses to $23.6 million, reflecting expanded clinical activity and commercialization preparation. Net loss widened to $63.5 million or $1.65 per share. Operationally, the company completed enrollment in its Phase 3 APOLLO bitopertin trial in EPP and advanced multiple Phase 1/2 studies, with several data readouts anticipated in late 2026.
Disc Medicine, Inc. is implementing a restructuring plan after receiving a complete response letter from the FDA on February 13, 2026 regarding its New Drug Application for bitopertin for erythropoietic protoporphyria and X-linked protoporphyria. The board approved the plan on February 26, 2026.
The company is reducing its workforce by approximately 20%, mainly in commercial and certain supporting functions, and expects to complete the restructuring in the second quarter of 2026. Disc Medicine expects to incur about $2.0 million of charges, primarily severance costs, recorded mainly in the first quarter of 2026, though actual costs may differ and additional expenses are possible.
Disc Medicine reported a larger full-year 2025 net loss of $212.2 million, or $6.01 per share, as it increased investment in its hematology pipeline. Research and development expenses rose to $170.6 million and selling, general and administrative costs to $65.4 million, reflecting advancing trials and commercialization preparations.
Cash, cash equivalents, and marketable securities reached $791.2 million as of December 31, 2025, boosted by $454.4 million of net proceeds from 2025 equity offerings, supporting a cash runway into 2029. The company received an FDA Complete Response Letter for bitopertin in EPP but is pursuing a traditional approval path, with Phase 3 APOLLO topline data expected in Q4 2026.
Disc Medicine received a Complete Response Letter from the FDA on February 13, 2026 for its bitopertin new drug application in erythropoietic protoporphyria. The FDA’s main objection is that changes in protoporphyrin IX have not yet shown a clear link to sunlight-exposure benefits in prior trials.
The agency wants additional clinical endpoint evidence and indicated it needs results from the ongoing Phase 3 APOLLO study before making an approval decision. APOLLO is a ~150-patient, 6‑month, randomized, placebo‑controlled trial with co‑primary endpoints of pain‑free sunlight time and PPIX change, with topline data expected in Q4 2026.
Disc plans a Type A FDA meeting, aims to submit a CRL response using APOLLO data in late 2026, and notes a typical FDA review goal of about six months, implying a potential updated decision by mid‑2027. Management states the company is well‑capitalized through the APOLLO readout and into additional pipeline milestones, maintaining cash runway guidance into 2029.
Disc Medicine reported that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for bitopertin to treat erythropoietic protoporphyria. The FDA agreed bitopertin significantly lowered the PPIX biomarker in Phase 2 trials but found no clear link between PPIX reductions and sunlight‑exposure clinical endpoints.
The agency said it needs results from Disc’s ongoing Phase 3 APOLLO trial, which could support traditional approval, and indicated the Complete Response Letter will delay any potential approval. APOLLO enrollment was completed in March 2026, topline data are anticipated in Q4 2026, and Disc expects an updated FDA decision by mid‑2027 after responding. Disc reported approximately $791 million in unaudited cash, cash equivalents, and marketable securities as of December 31, 2025 and continues to guide that this provides runway into 2029.
Disc Medicine, Inc. furnished an update on its liquidity, stating that preliminary unaudited cash, cash equivalents and marketable securities totaled approximately $791 million as of December 31, 2025. This figure is an estimate and may change once the year-end financial close and audit procedures are completed, so it is not a substitute for the company’s upcoming Form 10-K.
The company also highlighted recent achievements and key business objectives and milestones for 2026 and is sharing further details through a press release and an investor presentation. Disc Medicine plans to use these materials during its participation in the 44th Annual J.P. Morgan Healthcare Conference, including a scheduled investor presentation on January 14, 2026.
Disc Medicine, Inc. (IRON) furnished an update on its business by announcing financial results for the third quarter ended September 30, 2025, and providing a corporate update. The details are contained in a press release furnished as Exhibit 99.1.
The information under Item 2.02 is being furnished and is not deemed “filed” for purposes of Section 18 of the Exchange Act, and it is not incorporated by reference into other filings unless expressly stated. The company’s common stock trades on the Nasdaq Global Market under the symbol IRON.
Disc Medicine (IRON) entered an Underwriting Agreement for an underwritten offering. The Company sold 2,619,049 shares of common stock at $84.00 and, in lieu of common to certain investors, pre-funded warrants for 59,523 shares at $83.9999. A selling stockholder sold 297,619 shares at $84.00, and the underwriters exercised in full a 30‑day option to buy an additional 446,428 shares from the selling stockholder.
Net proceeds to the Company are expected to be approximately $210.9 million after underwriting discounts and estimated expenses. The Company will receive nominal proceeds, if any, from pre-funded warrant exercises and no proceeds from the selling stockholder’s sales. Management stated that existing cash, cash equivalents and marketable securities plus these proceeds are expected to fund operations into 2029. Closing is expected on October 22, 2025.
Each pre-funded warrant is immediately exercisable at $0.0001 per share (cash or cashless), subject to an ownership cap up to 24.99%, adjustable with notice and HSR Act thresholds where applicable. The pre-funded warrants will not be listed on Nasdaq.
Disc Medicine (IRON) furnished an update stating preliminary, unaudited cash, cash equivalents and marketable securities of approximately $615.9 million as of September 30, 2025. The company noted this figure is subject to change upon completion of quarter-end closing procedures and has not been audited or reviewed.
Disc also furnished a press release and filed an updated investor presentation highlighting its hematology portfolio and near‑term objectives, including programs bitopertin (GlyT1 inhibitor), DISC‑0974 (anti‑HJV; hepcidin suppression) and DISC‑3405 (anti‑TMPRSS6; hepcidin induction). The 8‑K materials under Items 2.02 and 7.01 were furnished, not filed.
Disc Medicine (IRON) reported receiving a Commissioner’s National Priority Voucher (CNPV) from the U.S. FDA for bitopertin in erythropoietic protoporphyria (EPP), including X‑linked protoporphyria. The company previously submitted a New Drug Application in September 2025 for patients aged 12 and older under the FDA’s accelerated approval pathway.
The CNPV program, announced in June 2025, is intended to speed development and review of drugs tied to U.S. national health priorities. A CNPV provides benefits such as enhanced communications and rolling review, with the opportunity to reduce application review times to one to two months. This update highlights a potential pathway for a shortened FDA review of bitopertin after the NDA submission.
Disc Medicine, Inc. reported that board member Mona Ashiya, Ph.D., a Class I director, resigned from its Board of Directors effective October 3, 2025. She also stepped down from the Board’s Compensation Committee and Nominating and Corporate Governance Committee. The company stated that her resignation was not due to any disagreement with Disc Medicine regarding its operations, policies, or practices. Following her departure, the size of the Board was reduced from nine members to eight.
Disc Medicine, Inc. (Nasdaq: IRON) has filed a Form 8-K announcing the election of Nadim Ahmed to its Board of Directors, effective 14 July 2025. Ahmed will serve as a Class I director until the company’s 2027 annual meeting and thereafter until a successor is elected or he resigns. Under the company’s non-employee director compensation policy, he will receive $40,000 in annual cash fees (paid $10,000 quarterly) and a non-statutory option for 20,000 shares of common stock priced at the market close on the effective date. The option vests one-third on the first anniversary and the balance in equal monthly installments over the next two years, contingent on continued service. The filing notes no related-party transactions involving Ahmed and states he will enter into the standard director indemnification agreement. No other material financial or operational disclosures were provided.