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) provided updates on its clinical programs and corporate changes. The FDA granted Fast Track Designation to FTX-6058 for sickle cell disease, with promising Phase 1b trial results showing up to 9.5% increases in fetal hemoglobin (HbF). Enrollment continues in the ongoing trials for both FTX-6058 and losmapimod, targeted for facioscapulohumeral muscular dystrophy. The company also announced a leadership change, appointing Robert J. Gould as interim CEO. Fulcrum expects sufficient cash runway to fund operations into late 2024.
Fulcrum Therapeutics has appointed Robert J. Gould, Ph.D. as interim CEO following the departure of Bryan Stuart to pursue other opportunities. This transition, effective January 3, 2023, comes as the company seeks a permanent CEO. Gould, a founding member and former CEO, brings over 35 years of industry experience and will guide the company through ongoing clinical programs, including FTX-6058 for sickle cell disease and losmapimod for facioscapulohumeral muscular dystrophy. The Board expressed confidence in Gould's leadership during this pivotal time.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of 400,000 stock options to four new employees as part of its 2022 Inducement Stock Incentive Plan. The options include 250,000 shares at an exercise price of $6.55 and 150,000 shares at $6.56, aligned with the closing prices of the Company’s stock on respective grant dates. Each option has a ten-year term and vests over four years, promoting employee retention and performance. Fulcrum focuses on treating genetically defined rare diseases, with lead programs targeting muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) will participate in a virtual fireside chat at the 2022 BofA Securities Biotech SMID Cap Conference on December 8, 2022, at 9:10 a.m. ET. The event aims to provide insights into the company's initiatives focused on genetically defined rare diseases. A live audio webcast will be accessible on the Fulcrum website, with an archived replay available for 30 days after the event. Fulcrum is advancing two key clinical programs: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of non-statutory stock options totaling 478,820 shares to four new employees, including 400,000 shares to Santiago Arroyo, M.D., Ph.D., the new Chief Medical Officer. The options, priced at $5.61 per share, are part of the 2022 Inducement Stock Incentive Plan and include a ten-year term with vesting over four years. Fulcrum is dedicated to addressing genetically defined rare diseases, focusing on advancing its lead drugs for facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics (NASDAQ: FULC) reported Q3 2022 results, maintaining a focus on clinical and operational progress. Key highlights include the selection of a 12mg dose for the Phase 1b trial of FTX-6058 for sickle cell disease (SCD) and positive 96-week data from the Phase 2 ReDUX4 trial of losmapimod. The equity raise yielded approximately $80.8 million, extending their cash runway into late 2024. The firm anticipates two registration-enabling trials in the next 18 months, with a Q3 net loss of $23.7 million, up from $20.7 million in Q3 2021.
Fulcrum Therapeutics (NASDAQ: FULC) enhances its leadership with the appointment of Santiago Arroyo, M.D., Ph.D., as Chief Medical Officer and Jeff W. Jacobs, Ph.D., as Chief Scientific Officer. Dr. Arroyo, with nearly 20 years in biopharmaceuticals, previously led clinical developments at Momenta Pharmaceuticals. Dr. Jacobs brings over 25 years of drug discovery experience, most recently at Goldfinch Bio. Both executives aim to advance Fulcrum's clinical programs, including therapies for facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease, by leveraging their extensive expertise.
Fulcrum Therapeutics (Nasdaq: FULC) announced its third-quarter 2022 financial results will be released on November 8, 2022, before U.S. markets open. Management plans to host a conference call at 8:00 a.m. ET to discuss the results and recent corporate developments. The company focuses on improving lives in genetically defined rare diseases and has ongoing clinical programs for losmapimod for FSHD and FTX-6058 for sickle cell disease. Interested parties can access the call through the Investor Relations section of the company's website.
Fulcrum Therapeutics (NASDAQ: FULC) announced its participation in two upcoming investor conferences. The first is the Credit Suisse 31st Annual Healthcare Conference on November 8, 2022, at 2:35 p.m. PT, featuring a fireside chat. The second is the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, at 4:30 p.m. ET, also including a fireside chat. Interested investors can listen to live webcasts through the Investor Relations section of Fulcrum's website, with archived replays available for 30 days.
Fulcrum Therapeutics announced promising data from the open-label extension of its Phase 2 ReDUX4 trial of losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD). Findings suggest losmapimod modifies disease progression, with 97% of participants on treatment at 96 weeks demonstrating improved muscle function. The trial showcased a favorable safety profile, with no serious adverse events. The results will be presented at the World Muscle Society Congress on October 12, 2022, reinforcing the potential of losmapimod as a first approved treatment for FSHD.
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