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 announced the resignation of Esther Rajavelu as CFO, effective April 21, 2023. Rajavelu will continue to support the company as a consultant to ensure continuity in financial operations. Interim CEO Robert J. Gould acknowledged her contributions and emphasized the company’s strong cash position, with a runway extending into mid-2025, which positions Fulcrum well for executing its financial strategy and achieving key priorities. The company remains focused on advancing its clinical programs, particularly losmapimod and FTX-6058, the latter currently under an FDA clinical hold.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced the grant of non-statutory stock options to two new employees, totaling 86,740 shares at an exercise price of $5.97. This grant, made under the Company’s 2022 Inducement Stock Incentive Plan, complies with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly thereafter, subject to continued employee service. Fulcrum is focused on rare genetic diseases, with key programs including losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease, the latter currently under FDA clinical hold.
Fulcrum Therapeutics (NASDAQ: FULC) is addressing a clinical hold on its Investigational New Drug application for FTX-6058, aimed at treating sickle cell disease, following the FDA's concerns over potential hematological risks. Despite this, recent Phase 1b trial data indicated significant increases in fetal hemoglobin, with up to 10.0% rise in the 12 mg cohort, suggesting therapeutic potential. The company is on track to complete enrollment in the Phase 3 REACH trial for losmapimod in facioscapulohumeral muscular dystrophy by 2H’23. Fulcrum reported a net loss of $109.9 million for 2022 but maintains a cash runway into mid-2025 after raising approximately $117.3 million in a public offering.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) will release its fourth quarter and full year 2022 financial results on March 9, 2023, before U.S. markets open. A conference call and webcast will follow at 8:00 a.m. ET. The company focuses on treatments for genetically defined rare diseases, with two lead clinical programs: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease. For more details, access the conference call via telephone or the company's website.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced a full clinical hold issued by the FDA on February 23, 2023, for its Investigational New Drug application of FTX-6058, aimed at treating sickle cell disease. The hold, based on preclinical data, requires Fulcrum to suspend dosing in its Phase 1b trial until clarification is provided by the FDA, expected within 30 days. Despite this setback, the interim president expressed optimism about addressing the FDA's queries and maintaining confidence in the drug's potential benefits. FTX-6058 is a small-molecule inhibitor under development to increase fetal hemoglobin levels in patients.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of stock options to two new employees as part of its 2022 Inducement Stock Incentive Plan. A total of 113,200 shares were granted at an exercise price of $12.41 each, reflecting the closing price on February 6, 2022. The options have a ten-year term and will vest over four years, beginning with 25% vesting after the first year and 6.25% quarterly thereafter. Fulcrum Therapeutics is focused on developing treatments for genetically defined rare diseases, with lead programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) announced management's participation in the virtual SVB Securities Global Biopharma Conference on February 15, 2023, at 10:00 AM ET. The presentation will be accessible via webcast on the company's website, with an archived replay available for 90 days. Fulcrum is dedicated to enhancing the lives of patients with genetically defined rare diseases, focusing on two lead programs: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease and other hemoglobinopathies. Their proprietary FulcrumSeek™ engine targets gene expression to tackle underlying genetic issues.
Fulcrum Therapeutics (FULC) announced a public offering of 9,615,384 common shares priced at $13.00 each, aiming to raise approximately $125 million before expenses. This offering is conducted under an existing shelf registration statement and is expected to close on or about January 20, 2023. The underwriters have a 30-day option to purchase an additional 1,442,307 shares. Goldman Sachs, SVB Securities, and Piper Sandler are managing the offering. The funds are aimed at advancing Fulcrum’s clinical programs targeting genetic rare diseases, specifically treatments for facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) has announced a public offering of $100 million in common stock, with an additional $15 million available to underwriters. The offering, led by Goldman Sachs & Co. LLC, SVB Securities, and Piper Sandler & Co., aims to support the company’s focus on genetically defined rare diseases. The shares will be offered under an effective shelf registration statement previously filed with the SEC. Completion of the offering is contingent on market conditions, with no assurance on final terms.
Fulcrum Therapeutics (Nasdaq: FULC) announced the grant of non-statutory stock options to new employees under its 2022 Inducement Stock Incentive Plan. A total of 29,200 options were awarded to two employees at an exercise price of $10.20 per share, reflecting the closing price on January 9, 2023. The options vest over four years, with 25% vesting after one year and the remaining 75% in quarterly installments over the next three years, contingent on continued employment. Fulcrum focuses on treating genetically defined rare diseases, with clinical programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.
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