Fulcrum Therapeutics Stock Price, News & Analysis

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.

Fulcrum Therapeutics (Nasdaq: FULC) announced its participation in two virtual investor conferences. The BTIG Virtual Biotechnology Conference 2020 is scheduled for August 11, 2020, at 1:00 p.m. ET, while the Canaccord Genuity 40th Annual Growth Conference will take place on August 13, 2020, at 1:30 p.m. ET. Interested investors can access live audio webcasts through the Investor Relations section of the Fulcrum website. The company focuses on treating rare genetic diseases and is advancing several clinical programs, including treatments for muscular dystrophy and sickle cell disease.

MyoKardia and Fulcrum Therapeutics have formed a strategic collaboration to develop targeted therapies for genetic cardiomyopathies. Fulcrum is set to receive an upfront payment of $12.5 million and may earn up to $302.5 million in milestone payments for the first product, with additional potential royalties on net sales. MyoKardia will handle all development and commercialization efforts, leveraging Fulcrum’s proprietary target discovery engine. This partnership aims to address critical patient needs in cardiovascular diseases, emphasizing both companies' strengths in precision medicine.

Fulcrum Therapeutics (Nasdaq: FULC) announced FDA clearance to initiate a Phase 3 trial of losmapimod for hospitalized COVID-19 patients at risk of serious illness. The trial, named LOSVID, will involve approximately 400 participants and evaluate the drug's efficacy compared to placebo. The primary endpoint focuses on mortality and respiratory failure by day 28, with interim results expected in Q4 2020. CEO Robert J. Gould expressed optimism about losmapimod's potential, emphasizing the urgency in addressing COVID-19. The trial will run alongside ongoing studies for facioscapulohumeral muscular dystrophy.

Fulcrum Therapeutics (Nasdaq: FULC) announced a successful closing of a $68.5 million private placement with institutional and accredited investors. The offering involved the sale of 4,029,411 shares at $17.00 per share. Proceeds will support research and development, focusing on losmapimod for facioscapulohumeral muscular dystrophy and potential COVID-19 applications, as well as advancing other clinical programs. The company will register the resale of shares with the SEC within 15 days. Forward-looking statements highlight potential operational risks.

Fulcrum Therapeutics (Nasdaq: FULC) has submitted an Investigational New Drug (IND) application to initiate a Phase 3 trial for losmapimod as a treatment for COVID-19. This decision follows prior clinical trials showing its potential to reduce inflammatory cytokines linked to poor COVID-19 prognosis. The company is also advancing its development programs for facioscapulohumeral dystrophy (FSHD) and sickle cell disease, with key milestones on track for late 2020. Fulcrum expects its financial resources to support operations into Q1 2022.