Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Rhea-AI Summary
Disc Medicine (NASDAQ:IRON) reported updated RALLY-MF Phase 2 data for DISC-0974 in myelofibrosis-related anemia at ASCO 2026.
According to the company, treatment reduced hepcidin by >75%, increased serum iron, produced durable hemoglobin and transfusion responses across subgroups, improved fatigue scores, and was generally well tolerated, supporting an FDA end-of-Phase 2 meeting in 2026.
AI-generated analysis. Not financial advice.
Positive
- >75% hepcidin reduction with corresponding serum iron increases
- 55% of nTD patients had ≥1.5 g/dL hemoglobin rise for ≥12 weeks
- 64% of TD Low patients achieved 16-week transfusion independence
- 50% of TD High patients achieved 12-week transfusion independence
- Clinically significant FACIT-Fatigue improvements in nTD and TD Low groups
- End-of-Phase 2 FDA meeting planned by year-end 2026
Negative
- Diarrhea reported as treatment-related adverse event in at least two subjects
- DISC-0974 remains investigational and is not approved in any jurisdiction
News Market Reaction – IRON
On the day this news was published, IRON declined 5.52%, reflecting a notable negative market reaction. This price movement removed approximately $152M from the company's valuation, bringing the market cap to $2.60B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IRON gained 3.45% while key biotech peers were mixed: AGIO -3.64%, TVTX -3.16%, TARS -0.79%, ARQT +0.54%, OCUL +0.34%, indicating a stock-specific reaction to the trial update.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 21 | ASCO data announcement | Positive | -3.3% | Planned ASCO oral presentation of RALLY-MF Phase 2 DISC-0974 data. |
| Mar 26 | Phase 3 enrollment | Positive | -3.1% | Completion and expansion of Phase 3 APOLLO enrollment for bitopertin in EPP. |
| Dec 06 | Initial RALLY-MF data | Positive | -1.1% | Positive initial Phase 2 DISC-0974 RALLY-MF data presented at ASH 2025. |
| Nov 03 | ASH presentation plan | Neutral | -1.8% | Announcement of upcoming ASH presentations including initial RALLY-MF data. |
| Sep 30 | NDA submission | Positive | +1.6% | NDA filed for bitopertin in EPP seeking accelerated approval and priority review. |
Clinical trial news has usually been followed by modest negative moves, suggesting a history of selling into positive development updates.
Over the past several months, Disc Medicine has repeatedly highlighted clinical milestones across its hematology portfolio. Prior RALLY-MF updates and conference presentation announcements around DISC-0974, as well as Phase 3 APOLLO enrollment and an NDA submission for bitopertin, were generally followed by small share price declines despite positive operational progress. Today’s updated Phase 2 RALLY-MF data extend this clinical story with more mature efficacy and tolerability results in MF-associated anemia.
Historical Comparison
In the past year, IRON’s 5 clinical-trial headlines saw an average -1.53% move. Today’s +3.45% gain on stronger RALLY-MF data represents a more favorable reaction than prior trial updates.
Clinical news has progressed from announcing and presenting initial RALLY-MF data to expanded, more mature Phase 2 results, alongside Phase 3 APOLLO enrollment completion and an NDA submission for bitopertin.
Market Pulse Summary
The stock moved -5.5% in the session following this news. A negative reaction despite the favorable RALLY-MF Phase 2 data would fit past patterns where IRON’s clinical updates saw an average move of -1.53%. The company has often experienced modest declines even on positive trial milestones, as seen around prior RALLY-MF disclosures. In such a scenario, attention would likely focus on longer-term regulatory milestones, additional data expected in Q4 2026, and how the broader MF anemia treatment landscape evolves.
Key Terms
myelofibrosis medical
hepcidin medical
jak inhibitor medical
facit-fatigue medical
mpn-saf tss50 medical
phase 2 medical
subcutaneously medical
fda regulatory
AI-generated analysis. Not financial advice.
- Demonstrated meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status
- Anemia response was seen independent of concomitant JAK inhibitor therapy use
WATERTOWN, Mass., June 02, 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 presents updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO Annual Meeting in Chicago, IL. In this updated data set, treatment with DISC-0974 shows substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.
“We are excited to have solidified and strengthened the magnitude, durability, and consistency of responses as we have enrolled more patients and extended follow-up,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. “The activity observed both with and without background JAK inhibitor therapy, together with improvements in transfusion burden and fatigue, continues to support the potential for DISC-0974 to serve a broad population of patients living with MF-associated anemia, an area where substantial unmet need remains.”
This 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.
Additional data from the RALLY-MF study is to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year.
DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.
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 its RALLY-MF Phase 2 clinical trial of DISC-0974 in patients with MF and anemia, including the results thereof and the projected timeline for the presentation of additional data; the therapeutic and market potential of DISC-0974; and the projected timeline for a potential end of Phase 2 meeting with the FDA. 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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