UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to___________ Commission file number: 001-39438 Disc Medicine, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1612845 (State or ...

Core Insights - Disc Medicine, Inc. reported financial results for Q4 and full year 2025, highlighting progress in its clinical programs and a strong cash position [1][5][6] Financial Performance - Cash, cash equivalents, and marketable securities totaled approximately $791 million as of December 31, 2025, up from $490 million in 2024, providing a runway into 2029 [6][11] - Research and Development (R&D) expenses increased to $170.6 million in 2025 from $96.7 million in 2024, driven by advancements in clinical studies and increased headcount [11][13] - Selling, General and Administrative (SG&A) expenses rose to $65.4 million in 2025 from $33.0 million in 2024, primarily due to increased headcount and infrastructure development [11][13] - The net loss for 2025 was $212.2 million, compared to a net loss of $109.4 million in 2024, attributed to higher operating costs [11][13] Clinical Developments - The Phase 3 APOLLO study for bitopertin is expected to complete enrollment in March 2026, with topline data anticipated in Q4 2026 [6][7] - Initial data from the Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) showed meaningful overall anemia responses across all patient subgroups [6][7] - The company is progressing with the Phase 2 study of DISC-3405 in polycythemia vera and has initiated a Phase 1b study in sickle cell disease, with data expected in the second half of 2026 [6][7] Pipeline Overview - Bitopertin is a GlyT1 inhibitor aimed at treating erythropoietic protoporphyria (EPP) [3] - DISC-0974 is an anti-hemojuvelin antibody focused on hepcidin suppression [4] - DISC-3405 is an anti-TMPRSS6 antibody targeting hepcidin induction [4]

On February 17, 2026, Hedge fund BVF disclosed a new position in Disc Medicine (NASDAQ:IRON), acquiring 650,000 shares. What happened According to a recent SEC filing dated February 17, 2026, BVF reported a new position in Disc Medicine, Inc. during the fourth quarter, acquiring 650,000 shares. The quarter-end value of the position stood at $51.62 million, reflecting both the purchase and share price movement over the period. What else to know This was a new position for BVF, with Disc Medicine repres ...

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Disc Medicine, Inc. (“Disc” or the “Company”) (NASDAQ: IRON). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Disc and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On January 15, 2026 ...

Core Viewpoint - The company received a complete response letter from the FDA regarding bitopertin, indicating that while there is evidence of its effectiveness in lowering protoporphyrin IX (PPIX), there is uncertainty about whether this reduction can predict clinical benefits [3]. Group 1: Regulatory Update - The FDA's complete response letter highlights sufficient evidence that bitopertin significantly lowers PPIX levels [3]. - However, the FDA expressed uncertainty regarding the correlation between PPIX reduction and actual clinical benefits [3].

Disc Medicine (NasdaqGM:IRON) Update / briefing February 17, 2026 08:00 AM ET Company ParticipantsDerek Archila - Managing DirectorDouglas Tsao - Managing DirectorJohn Quisel - CEORami Katkhuda - Managing DirectorSean Laaman - Executive DirectorStephen Willey - Managing DirectorWill Savage - Chief Medical OfficerConference Call ParticipantsBulchum Patel - AnalystEvan Seigerman - AnalystKristen Kluska - Equity Research AnalystRoger Song - Senior Equity Research AnalystNone - AnalystNone - AnalystOperatorGood ...

Disc to pursue traditional U.S. approval for bitopertin after FDA rejects new fast-track route | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo [Purchase Licensing Rights, opens new tab]- Companies[Disc Medicine Inc]FollowFeb 17 (Reuters) - Disc Medicine [(IRON.O), opens new t ...

February 2026 Bitopertin Regulatory Update 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, DISC-0974 and DISC-3405, and any developments or results in connection therewith; project ...

Core Viewpoint - The U.S. Food and Drug Administration (FDA) has declined to approve Disc Medicine's experimental drug bitopertin for treating erythropoietic protoporphyria, leading to a significant drop in the company's stock price by 31.6% to $48.90 [1]. Company Summary - Disc Medicine was seeking FDA approval for bitopertin, aimed at treating a rare genetic metabolic disorder caused by a deficiency of the ferrochelatase enzyme [1]. - The primary symptom of erythropoietic protoporphyria is hypersensitivity of the skin to sunlight [1].