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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 developing small molecules for rare genetic diseases, has announced its participation in three major healthcare conferences this December. The company will present at the Piper Sandler 36th Annual Healthcare Conference on December 3 with a fireside chat at 12:00 pm ET in New York, the Citi 2024 Global Healthcare Conference on December 4 in Miami, and the Evercore ISI 7th Annual HealthCONx Conference on December 5 in Miami. The Piper Sandler fireside chat webcast will be available on Fulcrum's website for at least 30 days after the presentation.
Fulcrum Therapeutics (FULC) reported Q3 2024 financial results and business updates. The company continues to progress with patient enrollment in the Phase 1b PIONEER trial of pociredir for sickle cell disease. Cash position stood at $257.2 million as of September 30, 2024, with runway extending into 2027. Q3 net loss was $21.7 million, compared to $24.0 million in Q3 2023. R&D expenses decreased to $14.6 million from $18.2 million year-over-year. The company suspended losmapimod development following September's REACH trial results and is now focusing on pociredir development and other early discovery programs.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company specializing in small molecule development for rare genetic diseases, has announced its participation in the Stifel Healthcare Conference. The company's management will engage in a fireside chat on November 19th at 3:35 pm ET in New York City, along with one-on-one investor meetings.
The fireside chat will be available via webcast, accessible through both a direct link and the Events and Presentations section of Fulcrum's website. A replay will remain available for at least 30 days after the presentation.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules for rare diseases, has scheduled its third quarter 2024 financial results release for Wednesday, November 13, 2024, before U.S. market open. The company will host a conference call and webcast at 8:00 a.m. ET to discuss results and provide corporate updates. Participants can register online to receive dial-in details and a unique PIN. The webcast will be available through the company's Investor Relations section, with an archived replay accessible afterward.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company, has announced the granting of non-statutory stock options to two new employees. These grants were made under the company's 2022 Inducement Stock Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
The new employees received an aggregate of 90,000 options to purchase Fulcrum's common stock at an exercise price of $3.57 per share, which was the closing price on the grant effective date, October 7, 2024. Each option has a ten-year term and vests over four years, with 25% vesting on the first anniversary of the employee's start date and an additional 6.25% vesting quarterly over the following three years, subject to continued employment.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company, has announced the granting of non-statutory stock options to three new employees. The grants were made under the company's 2022 Inducement Stock Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). An aggregate of 130,800 options were granted to purchase shares of Fulcrum's common stock at an exercise price of $8.63 per share, which was the closing price on September 9, 2024, the grant effective date.
Each option has a ten-year term and vests over four years, with 25% vesting on the first anniversary of the employee's start date and an additional 6.25% vesting quarterly over the following three years, subject to continued employment.
Fulcrum Therapeutics (NASDAQ: FULC) announced that its Phase 3 REACH trial for losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) failed to meet its primary endpoint. The trial showed no significant improvement in relative surface area (RSA) compared to placebo at week 48. Secondary endpoints also failed to achieve statistical significance. As a result, Fulcrum plans to suspend the losmapimod program in FSHD.
Key results include:
- Losmapimod group: 0.013 improvement in RSA
- Placebo group: 0.010 improvement in RSA
- No significant differences in muscle fat infiltration, shoulder abductor strength, or patient-reported outcomes
Despite this setback, Fulcrum remains financially stable with $273.8 million in cash and equivalents as of June 30, 2024. The company will redirect its resources to advance pociredir for sickle cell disease and other early-stage programs.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company, has announced its participation in two upcoming healthcare conferences in September 2024. The company, which focuses on developing small molecules for genetically defined rare diseases, will be attending:
1. The Wells Fargo Healthcare Conference on Wednesday, September 4, 2024, in Boston, MA.
2. The Morgan Stanley 22nd Annual Global Healthcare Conference on Friday, September 6, 2024, in New York, NY.
During these events, Fulcrum's management team will engage in a series of investor meetings, providing an opportunity to discuss the company's progress and future plans in the field of rare disease treatments.
Fulcrum Therapeutics (Nasdaq: FULC), a clinical-stage biopharmaceutical company, has granted non-statutory stock options to two new employees under its 2022 Inducement Stock Incentive Plan. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4). One employee received 350,000 options at an exercise price of $9.34 per share, effective August 19, 2024. Another employee was granted 270,000 options at $8.43 per share, effective July 29, 2024. Both 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 next three years, subject to continued employment.
Fulcrum Therapeutics (NASDAQ: FULC) has strengthened its leadership team with two key appointments. Isabel Kalofonos joins as Chief Commercial Officer, bringing extensive experience in rare disease drug launches, including ELAHERE® and TAKHZYRO®. Heather Faulds becomes Chief Regulatory Affairs & Quality Assurance Officer, with a strong background in neuromuscular diseases and regulatory strategies.
These appointments are important as Fulcrum prepares for the potential New Drug Application (NDA) submission and commercial launch of losmapimod for the treatment of FSHD, a rare genetic disease. Kalofonos's commercial expertise and Faulds's regulatory experience, particularly with the rapid FDA approval of SPINRAZA®, position Fulcrum to transition into a commercial-stage biotechnology company.
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