Fulcrum Therapeutics Stock Price, News & Analysis

Fulcrum Therapeutics, Inc. (FULC) provided a business update and financial results for Q3 2020, highlighting significant progress with clinical trials and management appointments. The full data from the ReDUX4 trial with losmapimod in FSHD is expected in 2Q 2021, with encouraging interim results. Phase 1 trial with FTX-6058 for sickle cell disease is on track for dosing by year-end 2020. With cash reserves of $127 million, the company expects to fund operations into 2Q 2022. Net loss for Q3 was $19 million, compared to $16.5 million in the previous year.

Fulcrum Therapeutics (Nasdaq: FULC) has initiated the screening of healthy volunteers in its Phase 1 clinical trial for FTX-6058, a small molecule aimed at treating sickle cell disease and β-thalassemia. The company will also present preclinical data on FTX-6058 at the upcoming ASH Annual Meeting from December 5-8, 2020. Preclinical studies indicate potential elevations of fetal hemoglobin by up to 30%. The results will support the ongoing clinical trial, highlighting FTX-6058's promise for addressing hemoglobinopathies.

Fulcrum Therapeutics (Nasdaq: FULC) announced that it will release its third quarter 2020 financial results on November 10, 2020, before U.S. markets open. A conference call and webcast will be held at 8:00 a.m. ET to discuss the results and corporate updates. The company specializes in treating genetically defined rare diseases, with products like losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease. For additional information, visit their Investor Relations webpage.

Fulcrum Therapeutics (Nasdaq: FULC) announced the initiation of an Investigational New Drug application for its Phase 1 trial of FTX-6058, targeting sickle cell disease. This small molecule aims to elevate fetal hemoglobin expression, potentially addressing a major unmet need in hemoglobinopathies. The trial consists of four parts focused on safety, tolerability, and pharmacokinetics. Positive preclinical results indicated up to a 30% increase in fetal hemoglobin, suggesting significant symptomatic relief for patients. Further details on the trial phases highlight the company's commitment to rare diseases.

Fulcrum Therapeutics (Nasdaq: FULC) announced its upcoming presentations at the 25th International Congress of the World Muscle Society regarding its studies on facioscapulohumeral muscular dystrophy (FSHD). Losmapimod, a potential treatment for FSHD, is currently in Phase 2 trials. Four posters will be presented, focusing on biomarkers and clinical trial designs. There are no approved therapies for FSHD, affecting 16,000 to 38,000 patients in the U.S. Fulcrum has also received orphan drug designation for losmapimod.

Fulcrum Therapeutics (NASDAQ: FULC) announced preclinical data supporting FTX-6058 for sickle cell disease treatment, showing up to 30% fetal hemoglobin expression increase. The company plans to begin a Phase 1 trial in healthy volunteers by year-end. FTX-6058 demonstrated good tolerability and target engagement in rodent models with once-a-day dosing. A non-provisional patent application for FTX-6058 has been published. The findings suggest FTX-6058 may provide a transformative therapy for patients, with a robust safety profile established.

Fulcrum Therapeutics (Nasdaq: FULC) announced its participation in three upcoming virtual investor conferences. Management will present at the Virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 10:00 a.m. ET, followed by the Morgan Stanley Virtual Global Healthcare Conference on September 16, 2020, at 11:00 a.m. ET, and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 4:40 p.m. ET. Live webcasts will be available on the Investor Relations section of their website, with archived replays for 90 days.

Fulcrum Therapeutics, Inc. (Nasdaq: FULC) reported its Q2 2020 financial results on August 11, 2020, highlighting progress in its clinical pipeline. Interim data from the ReDUX4 trial indicated a significant 38-fold reduction in DUX4-driven gene expression in patients treated with losmapimod. Cash reserves increased to $131.7 million, expected to sustain operations into Q1 2022. The company initiated a Phase 3 trial of losmapimod for COVID-19 and a Phase 1 trial for FTX-6058, which showed promising preclinical results. However, net loss rose to $15.7 million, up from $13.2 million the previous year.

Fulcrum Therapeutics (Nasdaq: FULC) announced interim results from its Phase 2 ReDUX4 trial targeting facioscapulohumeral muscular dystrophy (FSHD). The study evaluated losmapimod’s effect on DUX4-driven gene expression in muscle biopsies. Initial data from 29 participants revealed a 38-fold reduction in gene expression among those with the highest baseline levels after treatment, compared to a 5.4-fold reduction with placebo. However, overall results did not distinguish losmapimod from placebo across all subjects. Topline results are expected in Q1 2021, with full data in Q2 2021.