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 on July 15, 2022, the grant of non-statutory stock options totaling 33,620 shares to five new employees, as part of its 2022 Inducement Stock Incentive Plan. Each option has an exercise price of $5.69 per share and a ten-year term. Vesting occurs over four years, with 25% vesting after one year and 6.25% quarterly thereafter. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent in the biopharmaceutical sector focused on rare genetic diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announced that Chief Medical Officer Christopher Morabito will leave the company on July 13, 2022. Judith Dunn, President of Research and Development, will provide interim leadership during the search for a new CMO. She will oversee clinical activities, including the Phase 3 REACH trial of losmapimod for Facioscapulohumeral Muscular Dystrophy and the Phase 1b trial of FTX-6058 for sickle cell disease. CEO Bryan Stuart expressed confidence in the senior leadership's ability to achieve corporate objectives moving forward.
Fulcrum Therapeutics (Nasdaq: FULC) has initiated the REACH Phase 3 clinical trial, the first of its kind targeting FSHD, a debilitating muscular disease. The trial will evaluate losmapimod's safety and efficacy, involving 230 adults across over 30 sites in North America and Europe. If successful, losmapimod could become the first approved treatment for FSHD, following positive results from the Phase 2 ReDUX4 trial. The FDA granted Fast Track Designation for losmapimod in 2021, highlighting its potential to address significant unmet medical needs.
Fulcrum Therapeutics (Nasdaq: FULC) announced on June 10, 2022, the grant of nonstatutory stock options to eight new employees, totaling 112,800 shares. These options, with an exercise price of $7.53 per share, are designed as inducement awards under the 2022 Inducement Stock Incentive Plan.
Vesting occurs over four years, with 25% vesting after one year and the remainder in quarterly installments. Fulcrum focuses on developing therapies for genetically defined rare diseases, including treatments for facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics announced promising results from its Phase 1b trial of FTX-6058 for sickle cell disease (SCD). The investigational oral drug achieved up to a 6.3% increase in hemoglobin F (HbF) levels, indicating its potential as a transformative therapy. The drug was well tolerated, with no serious treatment emergent adverse events. Data will be presented at upcoming conferences, and the company plans to advance to further cohorts and a registrational trial in 2023.
Fulcrum Therapeutics announced the presentation of two posters and an accepted abstract at the European Hematology Association Hybrid Congress from June 9-12, 2022, in Vienna. The data will highlight FTX-6058, the only oral HbF inducer in clinical development for sickle cell disease, focusing on safety, tolerability, and pharmacokinetics. A virtual investor event is scheduled for June 10, 2022, to discuss initial data from the ongoing Phase 1b trial. The company emphasizes FTX-6058's potential to address significant unmet medical needs in this patient population.
Fulcrum Therapeutics (Nasdaq: FULC) announced a positive business update and 2022 Q1 financial results. The company will present initial data from the Phase 1b trial of FTX-6058 for sickle cell disease at EHA Congress in June 2022. Additionally, the Phase 3 REACH trial of losmapimod for Facioscapulohumeral Muscular Dystrophy (FSHD) is set to begin in 2Q 2022. Financially, Fulcrum reported a net loss of $25.9 million, worsening from $17.0 million in Q1 2021, while collaboration revenue decreased to $2.6 million from $4.8 million. Cash reserves stood at $195.1 million, sufficient to fund operations into 2024.
Fulcrum Therapeutics (NASDAQ: FULC) announced the grant of nonstatutory stock options to four new employees, totaling 76,000 shares under its 2022 Inducement Stock Incentive Plan. The options, issued as of May 2, 2022, have an exercise price of $9.80 per share, aligning with the closing share price on that date. Each option has a ten-year term with vesting over four years. This initiative aims to motivate new hires and align their interests with the company's goals in treating genetically defined rare diseases, including facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) announced its participation in a fireside chat at the BofA Securities 2022 Healthcare Conference on May 12, 2022, at 11:20 a.m. PT (2:20 p.m. ET). A live audio webcast will be available on Fulcrum’s Investor Relations page, with an archived replay for 30 days. Fulcrum specializes in developing treatments for genetically defined rare diseases, with lead programs including losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease and beta-thalassemia, leveraging their proprietary FulcrumSeek™ product engine.
Fulcrum Therapeutics (Nasdaq: FULC) announced it will release its first quarter 2022 financial results on May 9, 2022, prior to market opening. A conference call will follow at 8:00 a.m. ET to discuss these results and recent corporate developments. The company focuses on rare genetic diseases, with lead programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease. Their proprietary FulcrumSeek™ technology identifies drug targets to treat gene mis-expression.
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