Disc Medicine, Inc.

Disc Medicine announced updated positive data from multiple clinical programs at the EHA Annual Meeting. The RALLY-MF trial of DISC-0974 in myelofibrosis and anemia demonstrated meaningful and durable anemia responses across all patient subgroups, regardless of baseline transfusion status or JAK inhibitor use. Additionally, updated data from the HELIOS open-label extension trial of bitopertin in erythropoietic protoporphyria showed sustained reductions in PPIX, significant improvement in light tolerance, and a favorable longer-term safety profile. The company anticipates a catalyst-rich second half of the year, including End of Phase 2 discussions for DISC-0974 and Phase 3 readout for bitopertin.

Disc Medicine completed a Type A meeting with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) for its New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria (EPP). The company aligned with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a response to the CRL and could potentially support a traditional approval. Data from the APOLLO study is expected in Q4 2026, with a CRL response submission by the end of 2026 and an FDA decision anticipated by mid-2027.

Disc Medicine, Inc. announced the launch of an Expanded Access Program (EAP) for bitopertin, an investigational oral glycine transporter 1 (GlyT1) inhibitor. The program provides access to eligible patients aged 12 and above with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) in the U.S. who lack satisfactory therapeutic alternatives. Bitopertin is currently being evaluated in the Phase 3 APOLLO clinical trial, with topline data expected in Q4 2026 and a potential FDA decision by mid-2027.

Disc Medicine announced it will present data from multiple hematology programs at the European Hematology Association (EHA) 2026 Congress. The highlight is an oral presentation of Phase 2 RALLY-MF trial data for DISC-0974 in anemia of myelofibrosis, showing a 70% overall response rate among evaluable patients. The company will also provide updates on its bitopertin program for EPP and the DISC-3405 trial for polycythemia vera. Management will host a conference call on June 15 to discuss the presented data.

Disc Medicine, Inc. announced that its management will participate in fireside chats at two upcoming investor conferences. The first is the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 19th, and the second is the Jefferies Global Healthcare Conference on June 3rd. Live webcasts and archived replays of both events will be accessible through the company's investor relations website.

Disc Medicine, Inc. reported a net loss of $(63.5) million, or $(1.65) per share, for the first quarter of 2026, significantly wider than the $(34.1) million net loss, or $(1.02) per share, in the same period last year. Total operating expenses increased substantially, driven by higher research and development and selling, general and administrative costs. Despite the losses, the company maintains a strong liquidity position with $730.2 million in cash, cash equivalents, and marketable securities, expected to fund operations for at least the next twelve months.

Disc Medicine reported a net loss of $63.5 million for the first quarter ended March 31, 2026, an increase from $34.1 million in the prior year. Despite the increased loss due to higher operating costs, the company maintains a strong financial position with $730.2 million in cash, cash equivalents, and marketable securities, providing a runway into 2029. The company also announced significant progress in its clinical pipeline, including the completion of enrollment for the Phase 3 APOLLO study of bitopertin and upcoming data presentations for DISC-0974 and DISC-3405.

Disc Medicine reported Q1 2026 financial results and provided significant clinical pipeline updates. The company completed enrollment for its Phase 3 APOLLO study of bitopertin in EPP, with topline data anticipated in Q4 2026. Updated Phase 2 data for DISC-0974 in myelofibrosis anemia will be presented at ASCO. Studies for DISC-3405 in polycythemia vera and sickle cell disease are progressing, with data expected in Q4 2026. The company ended Q1 with $730.2 million in cash, providing a runway into 2029, despite a net loss of $63.5 million.

Disc Medicine, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 18, 2026. Stockholders will vote on the election of three Class III directors, an advisory resolution on executive compensation, and the ratification of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026. The board of directors recommends a "FOR" vote on all proposals.

Disc Medicine announced it will present data from its RALLY-MF Phase 2 trial of DISC-0974 for anemia of myelofibrosis at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026. The company's CEO highlighted initial data showing "unprecedented" anemia response rates in this difficult-to-treat patient population. While the abstract will be published online on May 21, 2026, new data and analyses are reserved for the conference presentation, indicating potential for further positive updates.