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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 (NASDAQ: FULC) announced results from its Phase 2b ReDUX4 trial of losmapimod for facioscapulohumeral muscular dystrophy (FSHD). While the primary endpoint of DUX4-driven gene expression was not met, significant clinical benefits were observed, including reduced muscle fat infiltration and improved functional outcomes. Losmapimod was well tolerated, with no serious adverse events related to treatment. The company plans to engage with the FDA regarding future regulatory steps in H2 2021. Overall, these results support losmapimod as a potential transformative therapy for FSHD.
Fulcrum Therapeutics (Nasdaq: FULC) will hold a conference call on June 24, 2021, at 8:00 am ET to discuss the results of the Phase 2b ReDUX4 trial involving losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD). The company is presenting multiple findings at the 28th Annual FSHD Society International Research Congress. These include efficacy and safety data from the trial. FSHD affects 16,000 to 38,000 patients in the U.S., with no approved treatments available. Losmapimod has received FDA Fast Track designation.
Fulcrum Therapeutics (Nasdaq: FULC) has received Fast Track designation from the FDA for losmapimod, aimed at treating facioscapulohumeral muscular dystrophy (FSHD), a disease with no approved therapies. This designation assists in expedited drug development and review. Recent Phase 2b trial data from ReDUX4 will be reported at the FSHD International Research Congress on June 24-25, 2021. Losmapimod, previously granted Orphan Drug Designation, has been evaluated in over 3,600 subjects without safety signals reported.
Fulcrum Therapeutics (Nasdaq: FULC) announced its participation in the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021, at 11:00 a.m. ET. The presentation will provide a corporate overview of the company, which focuses on genetically defined rare diseases. Investors can access a live audio webcast on Fulcrum's Investor Relations website, with an archived replay available for 90 days. The company is advancing treatments for conditions like facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) reported first quarter 2021 financial results, highlighting a cash position of $143.9 million, sufficient to fund operations into Q4 2022. Collaboration revenue surged to $4.8 million, up from $0.8 million YoY, attributed to partnerships with MyoKardia and Acceleron. Key clinical progress includes upcoming data from the Phase 2b ReDUX4 trial for facioscapulohumeral muscular dystrophy and the Phase 1 trial for sickle cell disease. The company has also appointed new leadership, enhancing its strategic capabilities.
Fulcrum Therapeutics appointed Dr. Christopher J. Morabito as Chief Medical Officer, effective May 10, 2021. Dr. Morabito brings over 20 years of experience in the biotechnology sector, focusing on advancing clinical programs for rare diseases, including facioscapulohumeral dystrophy (FSHD) and hemoglobinopathies such as sickle cell disease. His previous roles include leadership positions at Cardurion Pharmaceuticals and Takeda. The company aims to leverage his expertise to enhance its clinical pipeline and drug development initiatives.
Fulcrum Therapeutics (Nasdaq: FULC) announced that it will release its first quarter 2021 financial results on May 6, 2021, prior to market opening. A conference call and webcast are scheduled for 8:00 a.m. ET to discuss these results and the company's recent developments. Fulcrum is focused on treating genetically defined rare diseases, with its lead product, losmapimod, in Phase 2 clinical trials for facioscapulohumeral dystrophy (FSHD) and FTX-6058 in Phase 1 trials for sickle cell disease and beta-thalassemia.
Fulcrum Therapeutics (Nasdaq: FULC) has initiated dosing in its Phase 1 trial of FTX-6058, an orally bioavailable EED inhibitor targeting hemoglobinopathies like sickle cell disease and β-thalassemia. The trial is assessing the safety, tolerability, and pharmacokinetics of FTX-6058.
Preclinical results indicate a potential increase in fetal hemoglobin (HbF) levels of up to 30%. The company plans to report data from this trial mid-year and initiate a clinical trial in sickle cell patients by the end of 2021.
Fulcrum Therapeutics, a biopharmaceutical firm focused on genetically defined rare diseases, has appointed Dr. Judith A. Dunn as President of Research and Development. Dr. Dunn brings over 25 years of experience in global drug development, previously serving as Vice President at Roche. Her expertise will support Fulcrum's losmapimod and FTX-6058 programs. The company aims to advance these programs, including two INDs in the next 24 months, leveraging its proprietary FulcrumSeek platform for drug target identification.
Fulcrum Therapeutics (Nasdaq: FULC) announced new data on imaging biomarkers and clinical assessments for facioscapulohumeral muscular dystrophy (FSHD) at the 2021 MDA Conference. Whole body musculoskeletal MRI (WB-MSK-MRI) provides vital information on disease severity. FSHD-TUG, a mobility assessment, shows correlation with clinical outcomes. The company is on track to report data from its Phase 2b ReDUX4 trial for losmapimod in late 2Q 2021. This clinical development aims to improve treatment options for FSHD, a condition affecting approximately 16,000 to 38,000 patients in the U.S.
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