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 the granting of stock options to six new employees as part of its 2022 Inducement Stock Incentive Plan. A total of 148,320 stock options, exercisable at $24.00 per share, have been awarded. The options vest over four years, with 25% vesting on the first anniversary of employment and the remainder vesting quarterly thereafter. Fulcrum, focused on genetically defined rare diseases, is developing therapies such as losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) recently presented promising data on losmapimod, a treatment for facioscapulohumeral muscular dystrophy (FSHD), at the American Academy of Neurology Annual Meeting. The presentations outlined clinical data supporting losmapimod's potential to slow disease progression. The company plans to initiate the Phase 3 REACH trial in Q2 2022, aiming to enroll approximately 230 adults. Losmapimod has received FDA Fast Track and Orphan Drug Designation, highlighting its significance as a potential therapeutic option for FSHD.
Fulcrum Therapeutics (Nasdaq: FULC) will host a Key Opinion Leader meeting on March 24, 2022, to discuss the unmet need in facioscapulohumeral muscular dystrophy (FSHD) and their Phase 3 REACH trial for losmapimod, an investigational treatment. Esteemed experts Dr. Nicholas Johnson and Dr. Jay Han will join company executives for insights on disease progression and treatment landscape. FSHD affects 16,000 to 38,000 in the U.S., causing debilitating symptoms with no approved treatments available. Registration for the webcast is available on their website.
Fulcrum Therapeutics (NASDAQ: FULC) announced significant findings demonstrating that Reachable Workspace (RWS) effectively measures functionality in patients with facioscapulohumeral muscular dystrophy (FSHD). Data from two Phase 2 studies indicated that losmapimod, an investigational treatment, preserved or improved function as measured by RWS. The company is set to begin the Phase 3 REACH trial in Q2 2022, enrolling approximately 230 adults. RWS will serve as the primary endpoint, emphasizing the need for objective measures of disease progression.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of nonstatutory stock options to four new employees as part of its 2022 Inducement Stock Incentive Plan. A total of 31,520 stock options were awarded on March 7, 2022, each with an exercise price of $14.90, equal to the closing price of FULC's common stock on that date. The options will vest over a four-year period, starting with 25% vesting on the first anniversary of the employees’ start dates. The company focuses on treating genetically defined rare diseases.
Fulcrum Therapeutics (FULC) announced significant progress in its clinical trials during a business update on March 3, 2022. The company is set to initiate the Phase 3 REACH trial for losmapimod in the treatment of facioscapulohumeral muscular dystrophy (FSHD) by 2Q 2022, aiming to demonstrate efficacy and safety. Additionally, initial data from a Phase 1b trial for FTX-6058 in sickle cell disease is expected in 2Q 2022. Fulcrum reported a loss of $80.8 million for 2021 but ended the year with $218.2 million in cash, expected to sustain operations through 2024.
Fulcrum Therapeutics (NASDAQ: FULC) announced plans to initiate the REACH Phase 3 clinical trial of losmapimod for facioscapulohumeral muscular dystrophy (FSHD) in Q2 2022. FSHD is a debilitating disease with no approved treatments. The trial, which received alignment from the FDA and EU agencies, aims to enroll around 230 adults and assess losmapimod's efficacy in improving daily function. Previous Phase 2b results indicated promising outcomes in slowing disease progression. A key opinion leader webcast on FSHD is scheduled for March 24, 2022.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced it will release its fourth quarter and full year 2021 financial results on March 3, 2022, prior to U.S. market opening. A conference call will occur at 8:00 a.m. ET to discuss the results and corporate developments. Fulcrum focuses on addressing rare diseases through its leading programs: losmapimod for facioscapulohumeral muscular dystrophy (FSHD) and FTX-6058 for sickle cell disease. The company utilizes its proprietary FulcrumSeek™ engine to identify drug targets.
Fulcrum Therapeutics (NASDAQ: FULC) announced on February 11, 2022, the grant of inducement awards to Amy Winnen, the new Vice President, Head of Market Value, Access and Policy. The award includes a nonstatutory option to purchase 43,260 shares at an exercise price of $10.93, the closing price on February 7, 2022. Approved by independent directors, the option vests over four years and is part of Nasdaq Listing Rule compliance. Fulcrum focuses on developing treatments for genetically defined rare diseases, with lead programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focusing on genetically defined rare diseases, announced participation in the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 9:20 a.m. ET. A live audio webcast will be available on their investor relations website, with an archived replay accessible for 30 days. Fulcrum's lead programs include losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 targeting sickle cell disease.
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