Welcome to our dedicated page for Disc Medicine SEC filings (Ticker: IRON), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Disc Medicine filings document the regulatory and financial record of a clinical-stage biopharmaceutical company developing hematologic disease therapies. Its Form 8-K disclosures cover quarterly and annual financial results, corporate updates, clinical-program materials for bitopertin, DISC-0974 and DISC-3405, and FDA communications related to the bitopertin New Drug Application for erythropoietic protoporphyria.
The filing record also includes proxy materials covering board matters, executive compensation and shareholder voting items. Material-event reports describe Regulation FD presentations, operating runway disclosures, restructuring actions following regulatory developments, and risk-related statements around clinical trials, regulatory pathways, research spending and capital resources.
IRON reporting a Form 144 notice for proposed sale of 2,853 common shares tied to RSU vesting on 02/15/2026. The filing also records prior brokered 10b5-1 sales by Rahul Khara of 6,500 shares on 01/02/2026 for $511,471.98 and 1,000 shares on 01/20/2026 for $69,740.
SAVAGE submitted a Form 144 reporting a proposed sale of 3,256 shares of common stock of the company trading on NASDAQ, tied to an RSU vesting event dated 02/15/2026. The filing also records 13,093 shares sold on 12/15/2025 for $1,194,372.44.
IRON Form 144 filing reports proposed sales of Common shares tied to an RSU vesting and prior 10b5-1 activity. The filing shows 13,264 Common shares associated with RSU Vesting dated 02/15/2026 and a prior 10b5-1 sale by John Quisel of 40,000 Common shares on 12/11/2025, with a listed value of $742,120.80.
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's Chief Legal Officer, Rahul Khara, reported new equity awards in the company’s stock. On February 10, 2026, he acquired 17,000 shares of Common Stock as restricted stock units granted at $0 cost. These RSUs vest in four annual 25% installments starting February 15, 2027, contingent on continued service.
He was also granted a stock option for 25,500 shares of Common Stock at an exercise price of $74.75 per share, vesting in 48 equal monthly installments beginning March 10, 2026. Following these awards, he directly owned 55,026 Common shares and 25,500 option shares.
Disc Medicine’s Chief Commercial Officer Pamela Stephenson reported equity awards that increase her direct ownership stake. On February 10, 2026, she acquired 17,000 shares of common stock as restricted stock units at a grant price of $0, bringing her directly held common shares to 86,529.
She also received a stock option for 25,500 shares with an exercise price of $74.75 per share. The RSUs vest in four annual 25% installments starting February 15, 2027, and the option vests in 48 equal monthly installments starting March 10, 2026, in each case subject to continued service.