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 (FULC) has announced the presentation of multiple posters and oral presentations on losmapimod for facioscapulohumeral muscular dystrophy (FSHD) at the Virtual Congress of the World Muscle Society. Results from the Phase 2b ReDUX4 trial indicate significant benefits across various clinical endpoints. The company plans to meet with regulators in Q4 2021 and provide updates on losmapimod's clinical path in Q1 2022. FSHD currently has no approved therapies, highlighting the importance of this research.
Fulcrum Therapeutics (Nasdaq: FULC) announced the grant of a nonstatutory stock option to Mel Hayes, its newly appointed Chief Commercial Officer, as part of an inducement award. The award includes an option to purchase up to 140,000 shares at an exercise price of $28.49. This grant, approved on August 4, 2021, is valid for ten years and vests over four years. Fulcrum focuses on patients with rare genetically defined diseases, advancing treatments like losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) has appointed Mel Hayes as Chief Commercial Officer, effective September 7, 2021. Hayes, an industry veteran with over 25 years of experience in product commercialization, will lead the company's global strategy to maximize the potential of its therapies. The company is transitioning to a commercial-stage organization following advancements in its product pipeline, including losmapimod and FTX-6058, aimed at treating rare genetic diseases.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focused on genetically defined rare diseases, announced its participation in key investor conferences. Management will present at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 4:15 p.m. ET, followed by the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 a.m. ET, and the Cantor Virtual Global Healthcare Conference on September 28, 2021, at 3:20 p.m. ET. Live audio webcasts will be accessible on Fulcrum's Investor Relations page.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced the closing of its public offering of 7,590,000 shares at $19.00 each, raising $144.2 million in gross proceeds. The offering included 990,000 shares purchased at the underwriters' exercise option. The shares were sold under a previously effective SEC registration statement. SVB Leerink, Piper Sandler & Co., and Stifel served as joint bookrunning managers, while H.C. Wainwright & Co. led the offering management. The funds will support Fulcrum's ongoing clinical development of therapeutics for genetically defined rare diseases.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) has announced the pricing of a public offering of 6,600,000 shares of its common stock at $19.00 per share, aiming for total gross proceeds of approximately $125 million before expenses. The offering is expected to close on August 16, 2021. Additionally, underwriters have a 30-day option to purchase up to 990,000 extra shares. The offering is being conducted under a shelf registration statement and involves joint bookrunning managers SVB Leerink, Piper Sandler & Co., and Stifel.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company, has announced a public offering of $100 million in common stock, with an option for underwriters to purchase an additional $15 million. The offering is managed by SVB Leerink, Piper Sandler & Co., and Stifel. Fulcrum plans to use the proceeds to advance its clinical development programs, including drugs for rare diseases. The offering is subject to market conditions and follows a previously filed shelf registration with the SEC.
Fulcrum Therapeutics reported positive interim results from a Phase 1 trial with FTX-6058 for sickle cell disease, demonstrating proof of mechanism and biology. The company plans a Phase 1b trial in sickle cell patients in Q4 2021. Financially, Fulcrum's cash and equivalents rose to $125.6 million by June 30, 2021, supporting operations into Q1 2023. Collaboration revenue increased to $4.4 million, while net loss for Q2 2021 was $19.6 million. The firm remains focused on advancing therapies for rare genetic diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announced positive interim results from its Phase 1 trial of FTX-6058, showing a mean 4.5-fold induction of HBG mRNA and a 4.2-fold increase in F-reticulocytes at the 10mg dose after 14 days. The investigational drug, targeting hemoglobinopathies, was well tolerated with no serious adverse events reported. The company plans to initiate a Phase 1b trial in sickle cell patients by Q4 2021 and submit an IND application for non-sickle cell hemoglobinopathies by year-end 2021, highlighting a potential advancement in treatment options.
Fulcrum Therapeutics (Nasdaq: FULC) announced it will release its second quarter 2021 financial results on August 10, 2021, prior to market open. A conference call and webcast are scheduled for 8:00 a.m. ET to discuss the results and recent corporate developments. The company specializes in developing treatments for genetically defined rare diseases. It has advanced losmapimod into Phase 2 clinical trials for facioscapulohumeral dystrophy and FTX-6058 into Phase 1 clinical trials for sickle cell disease and beta-thalassemia.
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