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 (Nasdaq: FULC) announced a Key Opinion Leader (KOL) meeting on December 15, 2020, at 8:30 am ET to present their novel compound FTX-6058 targeting hemoglobinopathies, specifically sickle cell disease and beta-thalassemia.
Prominent experts, including Dr. Maureen Achebe and Dr. Gerd Blobel, will discuss the treatment landscape and answer questions. FTX-6058 is a small molecule designed to increase fetal hemoglobin expression, with promising preclinical results showing a potential 30% increase in HbF levels. A Phase 1 trial in healthy volunteers is underway.
Fulcrum Therapeutics (Nasdaq: FULC) announced the presentation of preclinical data on FTX-6058 for sickle cell disease during the virtual 62nd ASH Annual Meeting, December 5-8, 2020. FTX-6058, a potent EED inhibitor, showed potential to increase fetal hemoglobin (HbF) by approximately 30% in preclinical models, potentially transforming sickle cell treatment. The company has also initiated a Phase 1 trial with FTX-6058 in healthy volunteers. The robust pharmacological profile and mechanism of action could address significant unmet needs in sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) announced participation in two upcoming virtual investor conferences. The Stifel Virtual 2020 Healthcare Conference is scheduled for November 18, 2020, at 11:20 a.m. ET, while the Piper Sandler 32nd Annual Virtual Healthcare Conference will feature a prerecorded fireside chat on November 23, 2020, at 10:00 a.m. ET. Audio webcasts will be accessible on their Investor Relations website, with archived replays available for 90 days. Fulcrum focuses on addressing genetically defined rare diseases and is advancing several clinical programs.
Fulcrum Therapeutics, Inc. (FULC) provided a business update and financial results for Q3 2020, highlighting significant progress with clinical trials and management appointments. The full data from the ReDUX4 trial with losmapimod in FSHD is expected in 2Q 2021, with encouraging interim results. Phase 1 trial with FTX-6058 for sickle cell disease is on track for dosing by year-end 2020. With cash reserves of $127 million, the company expects to fund operations into 2Q 2022. Net loss for Q3 was $19 million, compared to $16.5 million in the previous year.
Fulcrum Therapeutics (Nasdaq: FULC) has initiated the screening of healthy volunteers in its Phase 1 clinical trial for FTX-6058, a small molecule aimed at treating sickle cell disease and β-thalassemia. The company will also present preclinical data on FTX-6058 at the upcoming ASH Annual Meeting from December 5-8, 2020. Preclinical studies indicate potential elevations of fetal hemoglobin by up to 30%. The results will support the ongoing clinical trial, highlighting FTX-6058's promise for addressing hemoglobinopathies.
Fulcrum Therapeutics (Nasdaq: FULC) announced that it will release its third quarter 2020 financial results on November 10, 2020, before U.S. markets open. A conference call and webcast will be held at 8:00 a.m. ET to discuss the results and corporate updates. The company specializes in treating genetically defined rare diseases, with products like losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease. For additional information, visit their Investor Relations webpage.
Fulcrum Therapeutics (Nasdaq: FULC) announced the initiation of an Investigational New Drug application for its Phase 1 trial of FTX-6058, targeting sickle cell disease. This small molecule aims to elevate fetal hemoglobin expression, potentially addressing a major unmet need in hemoglobinopathies. The trial consists of four parts focused on safety, tolerability, and pharmacokinetics. Positive preclinical results indicated up to a 30% increase in fetal hemoglobin, suggesting significant symptomatic relief for patients. Further details on the trial phases highlight the company's commitment to rare diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announced its upcoming presentations at the 25th International Congress of the World Muscle Society regarding its studies on facioscapulohumeral muscular dystrophy (FSHD). Losmapimod, a potential treatment for FSHD, is currently in Phase 2 trials. Four posters will be presented, focusing on biomarkers and clinical trial designs. There are no approved therapies for FSHD, affecting 16,000 to 38,000 patients in the U.S. Fulcrum has also received orphan drug designation for losmapimod.
Fulcrum Therapeutics (NASDAQ: FULC) announced preclinical data supporting FTX-6058 for sickle cell disease treatment, showing up to 30% fetal hemoglobin expression increase. The company plans to begin a Phase 1 trial in healthy volunteers by year-end. FTX-6058 demonstrated good tolerability and target engagement in rodent models with once-a-day dosing. A non-provisional patent application for FTX-6058 has been published. The findings suggest FTX-6058 may provide a transformative therapy for patients, with a robust safety profile established.
Fulcrum Therapeutics (Nasdaq: FULC) announced its participation in three upcoming virtual investor conferences. Management will present at the Virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 10:00 a.m. ET, followed by the Morgan Stanley Virtual Global Healthcare Conference on September 16, 2020, at 11:00 a.m. ET, and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 4:40 p.m. ET. Live webcasts will be available on the Investor Relations section of their website, with archived replays for 90 days.
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