Disc Medicine, Inc. - IRON STOCK NEWS

Disc Medicine (NASDAQ:IRON) presented positive updated results from its Phase 1b trial of DISC-0974 in patients with myelofibrosis (MF) and anemia at the 2024 ASH annual meeting. The trial enrolled 35 adult patients across different transfusion dependency groups and demonstrated significant clinical benefits.

Key results include: 68% of non-transfusion dependent patients achieved hemoglobin increase ≥1.5 g/dL; 100% of low transfusion dependent patients achieved ≥50% reduction in transfusion needs, with 80% reaching transfusion independence; 60% of high transfusion dependent patients achieved ≥50% reduction in requirements, with 40% reaching independence. The treatment showed >75% reduction in hepcidin across patients.

DISC-0974 was generally well-tolerated, with diarrhea being the only related adverse event reported in multiple subjects. The company has initiated a Phase 2 study following these positive results.

Disc Medicine (NASDAQ:IRON), a clinical-stage biopharmaceutical company specializing in treatments for hematologic diseases, has announced its participation in two upcoming investor conferences. The company will present at the Stifel 2024 Healthcare Conference on Tuesday, November 19th at 8:35 a.m. ET, and the Jefferies London Healthcare Conference on Thursday, November 21st at 9:30 a.m. GMT. Live webcasts will be accessible through the company's investor relations website, with archived replays available post-events.

Disc Medicine (NASDAQ:IRON) reported Q3 2024 financial results with a net loss of $26.6 million. The company ended Q3 with $487.4 million in cash and secured an additional $200 million non-dilutive debt financing. Key highlights include a successful FDA end of Phase 2 meeting for bitopertin in EPP with potential for accelerated approval, and positive proof-of-mechanism data for DISC-0974 in NDD-CKD patients. R&D expenses increased to $24.7 million from $14.4 million year-over-year, while G&A expenses rose to $8.2 million from $4.5 million. The company is funded into 2027.

Disc Medicine (NASDAQ:IRON) has secured a $200 million non-dilutive term loan facility from Hercules Capital. The financing includes an initial $30 million tranche at closing, with an additional $80 million available at Disc's discretion. The loan facility consists of four tranches maturing in November 2029, with at least 48-months of interest-only period, extendable to 60 months upon meeting certain milestones. The funding will support key developments including a confirmatory study of bitopertin in EPP, Phase 2 studies of DISC-0974 in anemia conditions, and DISC-3405 in polycythemia vera.

Disc Medicine (NASDAQ:IRON) has announced multiple presentations at the upcoming 66th American Society of Hematology (ASH) Annual Meeting in San Diego, December 7-10, 2024. The presentations include complete data from the Phase 1b trial of DISC-0974 in anemia of myelofibrosis and updates across their portfolio. The company will present clinical updates on core development programs in EPP, MF, and polycythemia vera, along with translational data from preclinical studies in new indications such as anemia of inflammatory bowel disease and sickle cell disease. Management will host a conference call on December 8 to review the presented data and discuss development plans.

Disc Medicine (NASDAQ:IRON) announced positive feedback from its end-of-Phase 2 meeting with the FDA regarding bitopertin for Erythropoietic Protoporphyria (EPP) treatment. The FDA agreed with all proposed study parameters for the APOLLO trial, including a primary endpoint measuring average monthly sunlight time without pain after 6 months of treatment. The company received potential for accelerated approval using PPIX reduction as a surrogate endpoint. The APOLLO trial, planned for mid-2025, will be a randomized, double-blind, placebo-controlled study using a 60 mg dose of bitopertin in EPP and XLP patients aged 12 and older.

Disc Medicine (NASDAQ:IRON) announced it will host a conference call on November 4, 2024, at 8:00 am EST to discuss feedback from its end-of-Phase 2 meeting with the FDA regarding bitopertin for Erythropoietic Protoporphyria (EPP). The company, which focuses on developing treatments for serious hematologic diseases, will make the call available through registration on their investor relations website.

Disc Medicine (NASDAQ:IRON) presented positive Phase 1b trial data for DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia. The single ascending dose (SAD) study included 40mg and 60mg cohorts, demonstrating that a single dose effectively suppressed hepcidin and increased iron mobilization, erythropoiesis, and hemoglobin levels. Key results showed >75% hepcidin reduction at the highest dose level, up to 3x increase in transferrin saturation, and mean hemoglobin increases of +0.54 g/dL at 40mg and +0.55 g/dL at 60mg compared to placebo. The treatment demonstrated acceptable safety with only Grade 1 or 2 related adverse events.

Disc Medicine (NASDAQ:IRON) has appointed Dr. Rahul Rajan Kaushik as Chief Technical Officer. Dr. Kaushik brings over 21 years of pharmaceutical development experience, specializing in Chemistry, Manufacturing, and Controls (CMC). He previously served as Senior VP of Technical Operations at FibroGen and held leadership positions at Nektar Therapeutics and Amgen. His experience includes successful development and regulatory approvals for multiple commercial products including Repatha®, Amgevita®, and contributions to Kyprolis®, Neulasta®, and Imlygic®. As part of his appointment, Disc granted Dr. Kaushik an inducement equity award including options for 55,000 shares and 36,666 restricted stock units.