Elritercept

Oral Presentation will Highlight 52-Week Safety and Durability of Response Data from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera (PV) Updated Phase 2 Results Demonstrating the Potential of Elritercept in Anemia Associated with Myelodysplastic Syndromes (MDS) and Myelofibrosis (MF) will be Shared in Oral Presentations OSAKA, Japan and CAMBRIDGE, Massachusetts, November 3, 2025 – Takeda (TSE: 4502/NYSE:TAK) will present the latest research from across its diverse portfolio and pipeline at the 67th American Society of Hematology (ASH) Annual Meeting being held December 6-9, 2025, in Orlando, Florida. More than twenty-five presentations will feature new clinical data in hematologic cancers and bleeding disorders, showcasing momentum for approved medicines and key late-stage programs. “At Takeda, we are driven by a legacy of advancing science where the need is greatest, as well as a passion for developing therapies that may help to address the needs of patients living with challenging and often underserved cancers and blood disorders,” said Phuong Khanh (P.K.) Morrow, MD, Head of the Oncology Therapeutic Area Unit at Takeda. “Our data at ASH reinforces this ongoing commitment to reducing disease and symptom burden, while informing the next generation of clinical decision-making. As a former clinician, I have seen firsthand the difference that new clinical insights and options can bring.” An oral presentation will detail 52-week data on durability of response on hematocrit control and patient reported outcome measures, and safety observations from the Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV). Earlier this year, 32-week results from the VERIFY study confirmed achievement of the primary endpoint as well as all four key secondary endpoints. Rusfertide is a first-in-class investigational hepcidin mimetic peptide therapeutic, which has received Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation from the U.S. Food & Drug Administration (FDA). Rusfertide or Placebo Plus Current Standard of Care Therapy for Polycythemia Vera: Durability of Response and Safety Results Through Week 52 From the Randomized Controlled Phase 3 VERIFY Study will be presented on December 6, 10:00 - 10:15 a.m. ET (Abstract 81) Two oral presentations will feature updated results from two separate Phase 2 studies evaluating elritercept in myelodysplastic syndromes (MDS) and myelofibrosis (MF). Elritercept is a late-stage investigational activin inhibitor designed to treat anemia associated with certain hematologic cancers, including MDS and MF. Elritercept shows durable responses in Lower-risk Myelodysplastic Neoplasms (LR-MDS) with Transfusion Dependence: Updated Results from an Ongoing Phase 2 Trial will be presented orally on December 8, 10:30 - 10:45 a.m. ET (Abstract 787) Hematological and Clinical Improvements with Elritercept (KER-050, TAK-226) at the Recommended Phase 2 Dose in Patients with Myelofibrosis Receiving Ruxolitinib: Updated Results from the Phase 2 RESTORE Trial will be presented orally on December 8, 3:15 - 3:30 p.m. ET (Abstract 909) Elritercept shows durable responses in Lower-risk Myelodysplastic Neoplasms (LR-MDS) with Transfusion Dependence: Updated Results from an Ongoing Phase 2 Trial will be presented orally on December 8, 10:30 - 10:45 a.m. ET (Abstract 787) Hematological and Clinical Improvements with Elritercept (KER-050, TAK-226) at the Recommended Phase 2 Dose in Patients with Myelofibrosis Receiving Ruxolitinib: Updated Results from the Phase 2 RESTORE Trial will be presented orally on December 8, 3:15 - 3:30 p.m. ET (Abstract 909) A poster presentation will feature new data from the Phase 3 study evaluating the perioperative use of VONVENDI® [von Willebrand factor (Recombinant)] in pediatric patients with von Willebrand disease. These data supported the September 2025 approval of the supplemental Biologics License Application for VONVENDI by the U.S. Food and Drug Administration. Recombinant von Willebrand Factor for Perioperative Management of Bleeding in Pediatric Patients with Severe von Willebrand Disease: Interim Results from a Phase 3 Multicenter Study and a Phase 3b Continuation Study will be presented on December 6, 5:30 - 7:30 p.m. ET (Abstract 1304) VONVENDI [von Willebrand factor (recombinant)] is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: On-demand treatment and control of bleeding episodes. Perioperative management of bleeding. For adult patients only: Routine prophylaxis to reduce the frequency of bleeding episodes. VONVENDI is contraindicated in patients who have had life-threatening hypersensitivity reactions to VONVENDI or constituents of the product (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins). Thromboembolic events have occurred with VONVENDI. These events can include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke. Patients with known risk factors for thrombosis, including low ADAMTS13 levels are at a higher risk. Monitor patients for signs and symptoms of thrombosis such as pain, swelling, discoloration, dyspnea, cough, hemoptysis, and syncope. Institute prophylaxis measures against thromboembolism according to current clinical practice and standard of care. In patients requiring frequent doses of VONVENDI in combination with rVIII, monitor plasma levels for FVIII:C activity because sustained excessive factor VIII plasma levels can increase the risk of thromboembolic complications. Hypersensitivity reactions and infusion-related reactions have occurred with VONVENDI. These reactions can include anaphylactic shock, generalized urticaria, angioedema, chest tightness, hypotension, shock, lethargy, nausea, vomiting, paresthesia, pruritus, restlessness, blurred vision, wheezing and /or acute respiratory distress. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VONVENDI and provide appropriate supportive care. VONVENDI contains trace amounts of mouse immunoglobulin G (MuIgG) and hamster proteins less than or equal to 2 ng/IU VONVENDI. Patients treated with this product may develop hypersensitivity reactions to non-human mammalian proteins. Neutralizing antibodies to VWF and/or factor VIII can occur with VONVENDI. If the expected plasma levels of VWF activity (VWF:RCo) are not attained, perform an appropriate assay to determine if anti-VWF or anti-factor VIII inhibitors are present. Consider other therapeutic options and direct the patient to a physician with experience in the care of either VWD or hemophilia A. In patients with high levels of inhibitors to VWF or factor VIII, VONVENDI therapy may not be effective, and infusion of this protein may lead to severe hypersensitivity reactions. Since inhibitor antibodies can occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors. Monitor plasma levels of VWF:RCo and factor VIII activities in patients receiving VONVENDI to avoid sustained excessive VWF and/or factor VIII activity levels, which may increase the risk of thrombotic events, particularly in patients with known clinical or laboratory risk factors. Monitor for development of VWF and/or factor VIII inhibitors when suspected. Perform appropriate inhibitor assays to determine if VWF and/or factor VIII inhibitors are present if bleeding is not controlled with the expected dose of VONVENDI. The most common adverse reactions observed in greater than or equal to 2% of patients in clinical trials with VONVENDI (n=132) were headache, vomiting, nausea, dizziness, and generalized pruritus. Please see VONVENDI U.S. full Prescribing Information. At Takeda Oncology, we are united by our aspiration to cure cancer, with inspiration from patients and innovation from everywhere. Drawing on decades of leadership in oncology, we work to develop innovative treatments that enhance and extend the lives of people living with cancer. We are committed to ensuring that patients globally can benefit from and access our portfolio of medicines, while also progressing a pipeline of potential treatments for the future. Our research and development efforts are focused on advancing medicines for hematologic, gastrointestinal and thoracic cancers by leveraging modalities best suited to make a difference in the treatment of these diseases. We complement our internal expertise and global footprint with a robust network of collaborators. Together, we strive to bring life-changing medicines to more patients around the world. For more information, visit www.takedaoncology.com. Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. 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LEXINGTON, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that, as part of its previously announced $375 million capital return program, it has commenced a cash tender offer to repurchase up to $194.4 million of shares of the Company’s common stock, subject to market conditions, at a purchase price of $17.75 per share. The Company expects to fund the tender offer from its existing cash and cash equivalents. The tender offer will expire at 5:00 p.m. ET on Tuesday, November 18, 2025, unless extended or earlier terminated. The full terms, conditions and other details of the tender offer are set forth in the offering documents that Keros filed today with the Securities and Exchange Commission (“SEC”). Neither the Company nor its Board of Directors has made, nor will make, any recommendation as to whether a stockholder should tender shares of the Company’s common stock. Stockholders must make their own decisions as to whether to tender their shares, after considering their own circumstances and preferences and consulting with their personal tax, financial and legal advisors. This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any shares of common stock. The solicitation and offer to buy common stock will only be made pursuant to the offer to purchase and the other tender offer documents. A free copy of the tender offer documents that will be filed by Keros with the SEC may be obtained when filed from the SEC’s website at www.sec.gov or by calling MacKenzie Partners, Inc., the information agent for the tender offer, at (800) 322-2885 (toll free). Stockholders are urged to read these materials carefully prior to making any decision with respect to the offer. Stockholders who have questions may call the dealer manager for the tender offer, Goldman Sachs & Co. LLC at (212) 902-8226 or MacKenzie Partners, Inc. at the number above. Additional Information Regarding The Tender OfferThis communication is for informational purposes only, is not a recommendation to buy or sell shares of the common stock and does not constitute an offer to buy or the solicitation of an offer to sell shares of the common stock. The tender offer described in this communication has not yet commenced, and there can be no assurances that the Company will commence the tender offer on the terms described in this communication or at all. The tender offer will be made only pursuant to an offer to purchase, letter of transmittal and related materials that the Company expects to distribute to its stockholders and file with the SEC upon commencement of the tender offer. STOCKHOLDERS AND INVESTORS SHOULD READ CAREFULLY THE OFFER TO PURCHASE, LETTER OF TRANSMITTAL AND RELATED MATERIALS BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION, INCLUDING THE VARIOUS TERMS OF, AND CONDITIONS TO, THE TENDER OFFER. Once the tender offer is commenced, stockholders and investors will be able to obtain a free copy of the tender offer statement on Schedule TO, the offer to purchase, letter of transmittal and other documents that the Company expects to file with the SEC at the SEC’s website at www.sec.gov or by calling the Information Agent (to be identified at the time the offer is made) for the tender offer. About Keros Therapeutics, Inc.Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Cautionary Note Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “continue,” “expects,” “enable,” “intention,” “potential” and “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the statements about the expected tender offer, including its expiration. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its product candidates, KER-065 and elritercept; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Keros’ filings with the SEC, including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2025, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ContactsInvestor Contact:Justin Frantzjfrantz@kerostx.com617-221-6042 Media Contact:Mahmoud Siddig / Adam Pollack / Brooks HusseyJoele Frank, Wilkinson Brimmer Katcher(212) 355-4449