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), a clinical-stage biopharmaceutical company, has announced the granting of non-statutory stock options to four new employees. The grants were made under the company's 2022 Inducement Stock Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). Three employees received a total of 131,300 options at an exercise price of $8.46 per share, while one employee received 150,000 options at $8.87 per share. These options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting quarterly over the following three years, subject to continued employment.
Fulcrum Therapeutics (NASDAQ: FULC) reported its Q2 2024 financial results and business highlights. Key points include:
1. The company is on track to report topline data for the Phase 3 REACH trial of losmapimod in FSHD by end of October 2024.
2. Fulcrum entered a collaboration and ex-U.S. license agreement with Sanofi for losmapimod development and commercialization.
3. Q2 2024 financials: $273.8 million in cash and equivalents, $80 million in collaboration revenue, and net income of $55.4 million.
4. The Phase 1b PIONEER trial of pociredir for sickle cell disease is progressing.
5. Fulcrum expects its current cash position to fund operations into 2027.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules for genetically defined rare diseases, has announced its plans to release second quarter 2024 financial results on Wednesday, July 31, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:00 a.m. ET on the same day to discuss the results and provide updates on recent corporate developments.
Interested parties can register for the conference call through a provided link, which will give them dial-in details and a unique PIN for access. An audio webcast will also be available through the company's Investor Relations section on their website.
Fulcrum Therapeutics (Nasdaq: FULC) will present at the 31st Annual FSHD Society International Research Congress in Denver, Colorado, on June 13-14, 2024. The presentations will cover various aspects of the Phase 3 REACH trial of losmapimod, a treatment for facioscapulohumeral muscular dystrophy (FSHD). Key presentations include an abstract on the baseline characteristics of trial participants, efficacy and progression of FSHD assessed by reachable workspace, and safety and tolerability of losmapimod. These findings will be disseminated through both poster and oral presentations, featuring various researchers, including Nicol Voermans, Joost Kools, Mihaela Levitchi Benea, and Lena Hubig.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in Goldman Sachs’ 45th Annual Healthcare Conference. Scheduled for June 10, 2024, at 10:00 a.m. ET, the company's management will engage in a fireside chat. A webcast of the presentation will be accessible via Fulcrum's website and available for replay for at least 30 days post-event. Fulcrum focuses on developing small molecules aimed at improving the lives of patients with genetically defined rare diseases.
Fulcrum Therapeutics, a biopharmaceutical company, announced recent business highlights and financial results for Q1 2024. They entered a collaboration with Sanofi for losmapimod, expect Phase 3 trial results in Q4 2024, appointed a new chief medical officer, and reported positive data on their Phase 2 study. Fulcrum's cash position decreased, with collaboration revenue at zero. R&D expenses increased, G&A expenses decreased, and net loss rose. Cash runway guidance extends into 2027.
Fulcrum Therapeutics has partnered with Sanofi for the development and commercialization of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD). Sanofi gains exclusive rights outside the U.S., while Fulcrum retains rights in the U.S. Fulcrum will receive an $80.0 million upfront payment, with potential milestones of $975.0 million and royalties. The collaboration combines Fulcrum's FSHD expertise with Sanofi's global reach.
Fulcrum Therapeutics, Inc. announced its participation in upcoming conferences, including the RBC Capital Market Global Healthcare Conference and the H.C. Wainwright 2nd Annual BioConnect Conference. The Company is focused on developing small molecules for genetically defined rare diseases.
Fulcrum Therapeutics, a biopharmaceutical company, published Phase 2b clinical trial results of losmapimod for FSHD in The Lancet Neurology. While not meeting the primary endpoint, losmapimod showed improvements in structural and functional outcomes, with Phase 3 data expected in Q4 2024.
Fulcrum Therapeutics, Inc. will host a conference call and webcast on May 13, 2024, to discuss its first quarter 2024 financial results and recent corporate developments. The company focuses on developing small molecules for rare diseases.
FAQ
What is the current stock price of Fulcrum Therapeutics (FULC)?
What is the market cap of Fulcrum Therapeutics (FULC)?
What is Fulcrum Therapeutics, Inc.?
What are Fulcrum's lead programs?
What is losmapimod?
What is pociredir?
What is FulcrumSeek™?
What recent achievements has Fulcrum made?
How is Fulcrum's financial health?
What is the focus of Fulcrum's clinical-stage programs?
Who are Fulcrum's strategic partners?
How can I find more information about Fulcrum's clinical trials?
