Disc Medicine Presents Positive Clinical Updates at the 2026 European Hematology Association (EHA) Annual Meeting
Rhea-AI Summary
Disc Medicine (NASDAQ: IRON) reported updated clinical data at the 2026 EHA meeting. Phase 2 RALLY-MF results for DISC-0974 in myelofibrosis anemia showed meaningful, durable anemia responses across transfusion subgroups and with/without JAK inhibitors, with generally favorable tolerability. Phase 2 HELIOS extension data for bitopertin in EPP showed sustained PPIX reductions, improved light tolerance, and longer-term safety. The company plans End-of-Phase 2 FDA discussions for DISC-0974 in 2026, a Phase 3 APOLLO readout for bitopertin in Q4 2026, and initial Phase 2 RESTORE-PV data for DISC-3405 in Q4 2026, and will host a corporate update call on June 15.
Positive
- RALLY-MF: ≥75% hepcidin reduction with corresponding increases in serum iron
- RALLY-MF: 55% of nTD patients had ≥1.5 g/dL hemoglobin rise for ≥12 weeks
- RALLY-MF: 64% TD Low and 50% TD High achieved transfusion independence
- RALLY-MF: DISC-0974 generally well-tolerated; diarrhea the only related AE seen in ≥2 patients
- HELIOS: sustained PPIX reductions and improved light tolerance with up to 2.5+ years exposure
- Bitopertin showed similar longer-term safety in adults and adolescents with EPP and XLP
Negative
- Bitopertin, DISC-0974, and DISC-3405 remain investigational and are not approved as therapies worldwide
News Market Reaction – IRON
In the Jun 12 session, IRON declined 0.13%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 09 | Regulatory meeting update | Positive | +2.1% | FDA Type A meeting clarified bitopertin path using APOLLO Phase 3 data. |
| Jun 02 | Clinical data update | Positive | -5.5% | ASCO RALLY-MF Phase 2 data showed robust anemia responses and tolerability. |
| Jun 01 | Access program launch | Positive | +3.5% | Expanded access program opened bitopertin to eligible EPP and XLP patients. |
| May 12 | Conference preview | Positive | -1.0% | Announced multiple EHA 2026 presentations across DISC-0974, bitopertin, DISC-3405. |
| May 11 | Investor conferences | Neutral | +1.4% | Management scheduled fireside chats at two investor conferences with webcasts. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news has produced mixed reactions: three positive or neutral items aligned with price gains, while two upbeat clinical/conference updates saw selloffs, indicating occasional profit-taking on good news.
Over the past month, Disc Medicine has reported several portfolio and regulatory milestones. A Jun 2 ASCO update on RALLY-MF showed positive anemia and tolerability data yet the stock fell, while a Jun 9 FDA Type A meeting outcome for bitopertin and a Jun 1 expanded access program both coincided with gains. Earlier EHA presentation announcements on May 12 and investor conference participation on May 11 saw only modest moves. Today’s detailed EHA data build directly on those prior clinical disclosures.
Key Terms
myelofibrosis medical
erythropoietic protoporphyria medical
protoporphyrin IX medical
hepcidin medical
JAK inhibitor medical
FACIT-Fatigue medical
MPN-SAF TSS50 medical
Rule 10b5-1 trading plan financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Data from the RALLY-MF trial of DISC-0974 in patients with myelofibrosis (MF) and anemia demonstrate meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status or concomitant JAK inhibitor use
- Updated data from the HELIOS open-label extension trial of bitopertin in erythropoietic protoporphyria (EPP) show sustained reductions in protoporphyrin IX (PPIX), significant improvement in light tolerance measures, and favorable longer-term safety
- Management will host a corporate update conference call on Monday, June 15 at 8:00 am ET
WATERTOWN, Mass., June 12, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announces updated data from multiple clinical programs to be presented at the EHA Annual Meeting in Stockholm, Sweden. Data from the RALLY-MF trial of DISC-0974 in patients with MF and anemia, to be presented in an oral session today, demonstrate meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status or concomitant JAK inhibitor use. Updated data from the HELIOS open-label extension trial of bitopertin in EPP, to be presented in a poster session tomorrow, June 13, show sustained reductions in PPIX, significant improvement in light tolerance measures, and favorable longer-term safety in patients treated with bitopertin.
“The updates at this year’s EHA highlight continued progress across our portfolio heading into a catalyst-rich second half of the year,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. “For DISC-0974 in MF anemia, our Phase 2 dataset continues to strengthen as we prepare for End of Phase 2 discussions with FDA by the end of this year. For bitopertin, continued durability of PPIX reduction and light tolerance improvement in HELIOS is encouraging leading up to the APOLLO Phase 3 readout in Q4, which, as confirmed in a recent Type A meeting with FDA, can serve as the basis for a response to the CRL and could potentially support a traditional approval if successful. We also look forward to sharing initial data from the RESTORE-PV Phase 2 trial of DISC-3405 in polycythemia vera in Q4 this year, setting up the potential for a third program in pivotal-stage development in 2027.”
Management will host a call following the EHA meeting to review highlights of the presented data and next steps for the company on Monday, June 15 at 8:00am EDT. Please register for the event on the Events and Presentations page of Disc’s website (https://ir.discmedicine.com/).
Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.
Details of Presentations and Abstracts:
DISC-0974: RALLY-MF Oral Presentation
RALLY-MF, an ongoing Phase 2 open-label study, had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:
- Consistent, substantial decreases in hepcidin reaching >
75% reduction from baseline and corresponding increases in serum iron 55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and73% achieved a ≥50% reduction in transfusions (overall response)50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and88% achieved a ≥50% reduction in transfusion requirement (overall response)56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received- Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
- Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
- MPN-SAF TSS50 at EOS was achieved by
50% of nTD and TD low major responders
- DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.
Bitopertin: HELIOS update poster
HELIOS is an ongoing Phase 2, open-label, long-term extension trial that enrolled 86 adult and adolescent patients with EPP from the BEACON and AURORA trials. Patients were randomized to receive 20 mg or 60 mg bitopertin in BEACON and 20 mg or 60 mg bitopertin or placebo in AURORA, with all patients transitioning to a 60 mg daily dose of bitopertin in HELIOS.
- Longer term treatment with bitopertin was associated with sustained reductions in the disease-causing toxin PPIX, with additional benefit for patients receiving the 60 mg dose continuously
- Treatment with bitopertin was associated with sustained, significant improvement in average light tolerance and time to prodrome measures
- Bitopertin exhibited a favorable longer-term safety profile with up to 2.5+ years of exposure and similar safety across adults and adolescents with EPP and XLP
DISC-3405: RESTORE-PV Trial-in-Progress poster
RESTORE-PV is a Phase 2 open-label study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DISC-3405 in patients with polycythemia vera. Initial data from the trial is expected in Q4 2026.
About Disc Medicine
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. For more information, please visit www.discmedicine.com.
Disc Cautionary Statement Regarding Forward-Looking Statements
This press release 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 the next stages of its development programs for bitopertin, DISC-0974 and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential for traditional approval, the potential for the APOLLO clinical trial to serve as the basis for any such approval, and the timing of any such approval, if granted; and anticipated discussions with regulatory agencies. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: the adequacy of Disc’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Disc; the difficulty in predicting the time and cost of development of Disc’s product candidates; Disc’s plans to research, develop and commercialize its current and future product candidates; the timing of initiation of Disc’s planned preclinical studies and clinical trials; the timing of the availability of data from Disc’s clinical trials; Disc’s ability to identify additional product candidates with significant commercial potential and to expand its pipeline in hematological diseases; the timing and anticipated results of Disc’s preclinical studies and clinical trials and the risk that the results of Disc’s preclinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Disc’s Annual Report on Form 10-K for the year ended December 31, 2025, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law.
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