Welcome to our dedicated page for Disc Medicine news (Ticker: IRON), a resource for investors and traders seeking the latest updates and insights on Disc Medicine stock.
Disc Medicine, Inc. (NASDAQ: IRON) is a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of hematologic diseases through innovative therapies. The company is primarily focused on manipulating the hepcidin pathway, which is the master regulator of iron metabolism, to address ineffective red blood cell production in various hematologic conditions. By leveraging new insights into hepcidin biology, Disc Medicine strives to bring hope and improved quality of life to patients who suffer from serious blood disorders.
Disc Medicine is currently advancing several first-in-class therapeutic candidates that target fundamental red blood cell biology pathways, including heme biosynthesis and iron homeostasis. Among its leading candidates is DISC-0974, an investigational monoclonal antibody designed to suppress hepcidin production by inhibiting the hemojuvelin (HJV) co-receptor. This novel treatment has shown promising results in reducing serum hepcidin and increasing serum iron levels, leading to improvements in hemoglobin and reduced transfusion burdens in myelofibrosis (MF) patients with anemia.
The company also boasts bitopertin, an orally administered GlyT1 inhibitor that modulates heme biosynthesis. Bitopertin has demonstrated significant efficacy in reducing PPIX levels and improving sunlight tolerance in patients with erythropoietic protoporphyria (EPP) during the phase 2 BEACON study. Disc Medicine is actively working on further trials to solidify these findings and expand its therapeutic applications.
On the financial front, Disc Medicine is well-supported by a robust pipeline of both clinical and preclinical candidates aimed at transforming the landscape of hematologic treatments. Recently, the company presented compelling data at the 65th American Society of Hematology (ASH) Annual Meeting, showcasing the potential of its portfolio. Their commitment to advancing these therapies is evident from their ongoing and upcoming clinical trials, including the phase 1b/2a study of DISC-0974 in chronic kidney disease (CKD) patients with anemia and the phase 1 study of DISC-3405 in healthy volunteers.
Disc Medicine continues to foster strategic partnerships and collaborations to accelerate the development and commercialization of its products. The company's vision is to address unmet medical needs in hematology and deliver innovative therapies that can change the standard of care for patients globally.
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.
Disc Medicine (NASDAQ:IRON) announced upcoming clinical data presentation at the 2024 American Society of Nephrology (ASN) Kidney Week, October 24-27, 2024, in San Diego. The presentation will feature additional data from Phase 1b trial of DISC-0974 in patients with non-dialysis dependent chronic kidney disease (NDD CKD) and anemia.
The poster will report on 40mg and 60mg dose cohorts, focusing on safety, pharmacokinetics, and effects of DISC-0974 on hepcidin, iron, and anemia. The randomized, placebo-controlled study aims to assess safety and changes to hepcidin, iron, and key hematologic parameters.
Dr. Pablo Pergola will present the abstract titled "A Phase 1b, Double-Blind, Placebo-Controlled Study of DISC-0974, an Anti-Hemojuvelin Antibody, in Patients with Non-Dialysis-Dependent Chronic Kidney Disease and Anemia" on Friday, October 25, 2024.
Disc Medicine (NASDAQ:IRON) has appointed Steve Caffé, MD as Chief Regulatory Officer. Dr. Caffé brings over 25 years of experience in global product development and regulatory affairs, with expertise in hematology, oncology, and rare diseases. He previously served as Head of Regulatory Affairs at CRISPR Therapeutics, contributing to the approval of Casgevy® for sickle cell disease and beta thalassemia.
Dr. Caffé's appointment comes at a important time for Disc Medicine as it transitions to a late-stage hematology company. His extensive experience, including contributions to over 40 new drug approvals worldwide, is expected to be valuable as Disc prepares for significant trial initiations across its portfolio in the coming year.
As part of his appointment, Dr. Caffé received an inducement equity award, including stock options and restricted stock units, subject to vesting conditions.
Disc Medicine (NASDAQ:IRON), a clinical-stage biopharmaceutical company focusing on hematologic diseases, has announced its participation in four upcoming investor conferences in September 2024. The company's management will engage in fireside chats at the following events:
- 2024 Wells Fargo Securities Healthcare Conference (Sept. 6, 10:15 a.m. ET)
- Morgan Stanley 22nd Annual Global Healthcare Conference (Sept. 6, 1:05 p.m. ET)
- H.C. Wainwright 26th Annual Global Investment Conference (Sept. 11, 9:30 a.m. ET)
- 2024 Cantor Global Healthcare Conference (Sept. 19, 8:00 a.m. ET)
Live webcasts of these fireside chats will be accessible through Disc Medicine's investor relations website, with archived replays available after each event.
Disc Medicine (NASDAQ:IRON) reported Q2 2024 financial results and provided a business update. The company presented positive data for all three programs at the EHA 2024 Congress, demonstrating potential efficacy for bitopertin in EPP and DISC-0974 in anemia of myelofibrosis. Disc plans to provide updates on regulatory interactions for these programs in H2 2024. The company strengthened its financial position through a $178 million common stock offering, ending Q2 with $501 million in cash, expected to fund operations into 2027.
Financial highlights include R&D expenses of $23.5 million, up from $12.1 million in Q2 2023, and G&A expenses of $7.4 million, up from $5.2 million. The net loss for Q2 2024 was $26.4 million, compared to $15.9 million in Q2 2023. Disc Medicine continues to advance its portfolio, with upcoming milestones including regulatory discussions and data readouts in H2 2024.
Disc Medicine, a clinical-stage biopharmaceutical company (NASDAQ: IRON), announced an underwritten offering of 4,944,000 shares at $36 per share, expecting to raise approximately $178 million. The offering, closing on June 17, 2024, is led by Frazier Life Sciences and Logos Capital, with participation from significant institutional investors. Proceeds will fund ongoing and new clinical research, working capital, and other corporate purposes. Leerink Partners is the sole bookrunner.
Disc Medicine presented positive clinical data at the European Hematology Association (EHA) 2024 Congress. Key highlights include:
1. Bitopertin in erythropoietic protoporphyria (EPP): AURORA study results showed significant reductions in protoporphyrin IX (PPIX) and improvements in light tolerance and quality of life.
2. DISC-0974 in myelofibrosis (MF): Phase 1b trial data demonstrated durable increases in hemoglobin levels and reductions in transfusion burden.
3. DISC-3405 in healthy volunteers: Phase 1 trial showed sustained hepcidin induction and serum iron suppression.
Disc Medicine highlighted these advancements supporting their ongoing development and potential therapeutic applications.
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