Welcome to our dedicated page for Fulcrum Therapeutics news (Ticker: FULC), a resource for investors and traders seeking the latest updates and insights on Fulcrum Therapeutics stock.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients with genetically defined rare diseases. The company focuses on developing small molecules to regulate gene expression and treat the root causes of these diseases.
Fulcrum's lead programs include losmapimod and pociredir (formerly known as FTX-6058). Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor licensed from GSK, aimed at treating facioscapulohumeral muscular dystrophy (FSHD). Clinical trials have shown promising results, including slowed disease progression and improved muscle function. Losmapimod has received Fast Track and Orphan Drug Designations from the U.S. FDA and is currently in a Phase 3 multi-center randomized, double-blind, placebo-controlled study.
Pociredir is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED), targeting sickle cell disease (SCD) and other hemoglobinopathies. It works by increasing the expression of fetal hemoglobin, combating the genetic causes of these diseases. Clinical trials have demonstrated proof-of-concept and an increase in fetal hemoglobin levels. Pociredir also holds Fast Track and Orphan Drug Designations from the FDA.
Fulcrum's proprietary technology platform, FulcrumSeek™, identifies drug targets capable of modulating gene expression, allowing for the development of breakthrough therapies. The company's robust pipeline is supported by strong financial health, with sufficient funding expected to cover operating expenses and capital expenditure requirements into mid-2025. Strategic partnerships, such as the collaboration with Sanofi for the commercialization of losmapimod outside the U.S., further enhance its global reach and capabilities.
Recent News Highlights:
- Completion of patient enrollment for the Phase 3 REACH trial of losmapimod, with topline data expected in Q4 2024.
- Resolution of the FDA clinical hold on pociredir, with plans to resume enrollment for the Phase 1b PIONEER trial.
- Collaboration and license agreement with Sanofi for the global commercialization of losmapimod.
- Publication of Phase 2b clinical trial results of losmapimod in The Lancet Neurology, validating its therapeutic potential.
- Conference calls and webcasts to provide updates on financial results and business highlights.
Fulcrum Therapeutics reported a net loss of $17.7 million in Q4 2020, compared to $16.1 million in Q4 2019, and a total annual net loss of $70.8 million, down from $82.7 million in 2019. The company raised $50.6 million in gross proceeds from a public offering in January 2021, extending its cash runway into Q4 2022. Significant milestones are anticipated in 2021, including data releases from the Phase 2b trial of losmapimod in FSHD and Phase 1 trial of FTX-6058 for sickle cell disease. Fulcrum is discontinuing its Phase 3 COVID-19 trial to focus on rare diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announces leadership changes effective March 31, 2021. Bryan E. Stuart, the current COO, will succeed Robert J. Gould, Ph.D., who is retiring but will remain on the Board as an advisor. Mark Levin will become executive chair. Stuart brings over 20 years of experience in rare diseases, and his leadership is expected to drive growth in Fulcrum’s clinical programs. Currently, Fulcrum is advancing therapies for facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) will announce its Q4 and full year 2020 financial results on March 4, 2021, prior to U.S. market opening. A conference call and webcast will follow at 8:00 a.m. ET to discuss the results and company updates. Fulcrum is advancing its proprietary product engine aimed at treating genetically defined rare diseases, with notable developments including losmapimod in Phase 2 for FSHD and Phase 3 for COVID-19, alongside FTX-6058 in Phase 1 for sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) recognizes Rare Disease Day 2021, emphasizing the importance of community support for those affected by rare diseases, especially during COVID-19. The company highlights challenges faced by patients with facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease (SCD) while announcing initiatives to raise awareness and foster connections within the rare disease community. Fulcrum's ongoing clinical developments include losmapimod for FSHD and FTX-6058 for SCD. The press release also underscores the absence of approved therapies for these conditions.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focused on genetically defined rare diseases, announced its upcoming participation in two virtual investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is scheduled for February 25, 2021, at 10:40 a.m. ET. The H.C. Wainwright Global Life Sciences Conference will feature a prerecorded fireside chat on March 9, 2021, at 7:00 a.m. ET. Audio webcasts will be accessible through the Investor Relations section of the Fulcrum website for 90 days after each event.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) has successfully closed its public offering of 4,600,000 shares at $11.00 each, generating total gross proceeds of $50.6 million. This offering included 600,000 shares from underwriters exercising their option to purchase additional shares. The company aims to utilize these funds to advance its clinical trials for treatments targeting genetically defined rare diseases, including facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics has announced a public offering of 4,000,000 shares of its common stock at $11.00 each, totaling gross proceeds of $44 million, before expenses. The offering is fully underwritten and expected to close on January 22, 2021. Additionally, the underwriters have a 30-day option to purchase up to 600,000 more shares. The offering is registered under an effective shelf registration statement with the SEC. Funds from this offering will support the company's clinical programs for rare diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announced the commencement of an underwritten public offering of its common stock, entirely offered by the company. The offering will include a 30-day option for underwriters to purchase an additional 15% of the shares. This follows a previously filed shelf registration statement with the SEC. Joint book-running managers for the offering include SVB Leerink, Piper Sandler & Co., and Credit Suisse. The completion of the offering is subject to market conditions, and there is no assurance regarding its final terms.
Fulcrum Therapeutics (Nasdaq: FULC) has promoted Christopher Moxham, Ph.D. to chief scientific officer, effective February 5, 2021. He will lead the company’s drug discovery and translational science efforts, including advancing FTX-6058 for sickle cell disease and beta thalassemia. Owen Wallace, Ph.D., the previous CSO, will transition to the Scientific Advisory Board, contributing his expertise to ongoing R&D. Moxham brings over 20 years of experience in drug discovery, previously at Eli Lilly, and is expected to enhance Fulcrum's pipeline development.
Fulcrum Therapeutics (Nasdaq: FULC), a biopharmaceutical company focused on rare diseases, announced management's participation in a fireside chat at the virtual H.C. Wainwright BioConnect Conference. The live webcast will be accessible on January 11, 2021, at 6:00 a.m. ET through the conference portal and the company's investor relations site. An archived replay will be available for 90 days post-conference. Fulcrum is advancing treatments such as losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease in clinical development.
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