Disc Medicine Updates DISC-0974 Trial Data
Disc Medicine presented updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO Annual Meeting in Chicago. 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. 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. The trial was comprised of both patients receiving concomitant JAK inhibitor therapy and not receiving JAK inhibitor therapy. 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 greater than 75% reduction from baseline and corresponding increases in serum iron; 55% of baseline nTD patients achieved a hemoglobin increase of 1.5 g/dL for 12 weeks and 68% had an increase of =1 g/dL for =12 weeks; 64% of TD Low patients achieved transfusion independence over a 16-week period and 73% achieved a 50% reduction in transfusions; 50% of TD High patients achieved transfusion independence over a 12-week period and 88% achieved a 50% reduction in transfusion requirement; 56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% 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 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, 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.
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- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Disc Medicine (NASDAQ: IRON) for possibly issuing misleading business information, and investors may be entitled to compensation without any out-of-pocket costs.
- FDA Denial of NDA: On February 13, 2026, the FDA issued a Complete Response Letter to Disc Medicine, stating that uncertainties in the new drug application prevented approval, resulting in a 22% drop in stock price on the same day, indicating market concerns about the company's product prospects.
- Class Action Preparation: The Rosen Law Firm is preparing a class action to seek recovery for investor losses, which could impact Disc Medicine's reputation and future financing capabilities as it faces legal scrutiny.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing its strong track record and expertise, which may encourage more investors to join the lawsuit.
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Disc Medicine (NASDAQ: IRON) for allegedly issuing misleading business information, allowing affected shareholders to seek compensation without upfront costs.
- FDA Denial of NDA: On February 13, 2026, the FDA issued a Complete Response Letter to Disc Medicine, stating that uncertainties in the new drug application led to its rejection, causing the stock price to plummet by 22% on the same day, indicating significant market concerns about the company's prospects.
- Class Action Preparation: The Rosen Law Firm is preparing a class action to recover investor losses, encouraging affected investors to join through their website or by phone, demonstrating the firm's commitment to protecting investor rights.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first in 2017 for the number of securities class action settlements, showcasing its expertise and successful track record in this field.
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Disc Medicine, Inc. (NASDAQ:IRON) due to allegations of materially misleading business information, indicating legal risks that could affect shareholder returns.
- FDA Application Rejection: On February 13, 2026, the U.S. FDA issued a Complete Response Letter to Disc Medicine, rejecting its new drug application and citing the need for additional evidence to resolve uncertainties, which led to a 22% drop in the company's stock price on the same day.
- Class Action Preparation: The Rosen Law Firm is preparing a class action against Disc Medicine, allowing affected investors to seek compensation without any out-of-pocket costs, providing a potential financial recovery opportunity for investors.
- Law Firm Background: The Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing its strong capabilities and successful track record in securities litigation, thereby enhancing investor confidence in their representation.
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Disc Medicine (NASDAQ: IRON) for possibly issuing misleading business information, which could expose the company to legal liabilities.
- Stock Price Plunge: On February 13, 2026, Disc Medicine's stock fell 22% following the FDA's Complete Response Letter regarding its new drug application, indicating significant market concerns about the company's future prospects.
- Class Action Preparation: The firm is preparing a class action lawsuit, allowing affected investors to seek compensation without any out-of-pocket costs, which could have a substantial impact on the company's financial health.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, demonstrating its strong track record and expertise in this legal domain.
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Disc Medicine (NASDAQ: IRON) for allegedly issuing misleading business information, indicating significant legal risks that could impact stock price and investor confidence.
- FDA Rejection of NDA: On February 13, 2026, the FDA issued a Complete Response Letter rejecting Disc Medicine's new drug application due to uncertainties requiring additional evidence, resulting in a 22% stock price drop on the same day, reflecting market concerns over the company's product prospects.
- Class Action Preparation: The Rosen Law Firm is preparing a class action lawsuit, allowing affected investors to seek compensation without upfront costs, which may attract more investor attention and increase legal pressure on the company.
- Law Firm's Background: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing its strong track record and expertise in securities litigation, which may influence the outcome of future lawsuits against Disc Medicine.
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims on behalf of Disc Medicine, Inc. (NASDAQ:IRON) shareholders due to allegations of misleading business information, aiming to protect investor rights and seek compensation.
- FDA Response Letter Impact: On February 13, 2026, the FDA issued a Complete Response Letter to Disc Medicine, stating it could not approve the new drug application, resulting in a 22% stock price drop that day, directly impacting investors' financial positions.
- Class Action Preparation: The firm is preparing a class action lawsuit, allowing investors to participate in claims without any out-of-pocket costs, demonstrating its commitment to addressing investor losses and providing legal support.
- Firm Reputation: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, highlighting its leadership and expertise in the industry.







