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 first patient has been dosed in the Phase 1b trial of FTX-6058 for sickle cell disease, with initial data expected in 2Q 2022. An IND submission for FTX-6058 to support trials in select hemoglobinopathies is also planned for 2Q 2022. The company aims to provide updates on losmapimod in 1Q 2022. Kate Haviland has been appointed chair of the board of directors. Fulcrum reported a cash position of $218.2 million as of December 31, 2021, sufficient to fund operations into 2024.
Fulcrum Therapeutics (Nasdaq: FULC) announced the grant of an inducement award to newly appointed CFO Esther Rajavelu, approved by independent directors on January 3, 2022. The award includes a nonstatutory option to purchase 200,000 shares at an exercise price of $17.82, equal to the closing stock price on the grant date. The option has a ten-year term with 25% vesting after one year and subsequent quarterly vesting over three years, contingent on continued service. Fulcrum focuses on rare genetic diseases with lead programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) announced that Bryan Stuart, President and CEO, will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 12:00 p.m. ET. A live audio webcast of the presentation will be available on the Investor Relations section of Fulcrum's website, with an archived replay accessible for 30 days following the event.
Fulcrum focuses on addressing rare diseases through innovative treatments like losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease, leveraging its proprietary product engine, FulcrumSeek™.
Fulcrum Therapeutics (NASDAQ: FULC) announced the appointment of Esther Rajavelu as Chief Financial Officer, effective immediately. Rajavelu brings nearly 20 years of experience in the life sciences sector, having held senior positions at UBS, Deutsche Bank, and Bank of America. Fulcrum is focusing on the development of therapies for rare genetic diseases, with promising clinical data for its products losmapimod and FTX-6058.
The company is preparing for significant growth, enhancing its leadership team with Rajavelu's strategic financial expertise.
Fulcrum Therapeutics (NASDAQ: FULC) reported promising results from its Phase 1 trial of FTX-6058, achieving a mean 5.6-fold and 6.2-fold induction of HBG mRNA at 20mg and 30mg doses, respectively, after 14 days. The treatment was well-tolerated, with no serious adverse events noted. New data indicates FTX-6058 effectively downregulates BCL11A and MYB, which are critical repressors of fetal hemoglobin. The company plans to start a Phase 1b trial for sickle cell disease by year-end 2021 and aims to submit an IND for other hemoglobinopathies.
Fulcrum Therapeutics (NASDAQ: FULC) has appointed Sonja L. Banks to its board of directors, effective December 8. Banks, currently the CEO of the International Dyslexia Association, brings 25 years of experience in patient advocacy and non-profit leadership. Her appointment aligns with Fulcrum's mission to advance therapies for rare genetic diseases like sickle cell disease and FSHD. Management believes Banks' expertise will enhance its programs aimed at improving patient outcomes in these areas.
Fulcrum Therapeutics (NASDAQ: FULC) provided a business update and reported Q3 2021 results, highlighting progress in clinical trials. The company is set to initiate a Phase 1b trial for FTX-6058 in sickle cell disease by year-end 2021, with an investigational new drug application expected for other hemoglobinopathies shortly after. Fulcrum raised $144.2 million in August 2021, securing its cash runway into 2024. Collaboration revenue rose to $4.9 million from $1.8 million YoY, while net loss increased to $20.7 million versus $19.0 million YoY. Key updates on losmapimod are anticipated in Q1 2022.
Fulcrum Therapeutics (Nasdaq: FULC) announced management participation in key investor conferences. These include the Credit Suisse 30th Annual Virtual Healthcare Conference on November 11, 2021 at 4:20pm ET, the Stifel Virtual Healthcare Conference on November 17, 2021 at 11:20am ET, and the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 30, 2021. Live audio webcasts will be accessible via the Investor Relations section of the Fulcrum website, with archived replays available for 30 days.
Fulcrum Therapeutics (FULC) will release its Q3 2021 financial results on November 4, 2021, before U.S. markets open. A conference call and webcast will follow at 8:00 a.m. ET to discuss results and recent corporate developments. Fulcrum's focus is on patients with genetically defined rare diseases, with notable advancements including losmapimod in Phase 2 trials for facioscapulohumeral muscular dystrophy and FTX-6058 in Phase 1 trials for sickle cell disease and beta-thalassemia.
Fulcrum Therapeutics (Nasdaq: FULC) announced the approval of an inducement award for Naomi Aoki, the newly appointed SVP of Communications and Investor Relations, on September 10, 2021. The grant includes a nonstatutory stock option for 58,000 shares at an exercise price of $28.21, the closing price on September 30, 2021. The option has a ten-year term and vests over four years, promoting retention through gradual vesting. Fulcrum Therapeutics focuses on developing treatments for genetically defined rare diseases, advancing losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease.
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