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Fulcrum Therapeutics, Inc. reports developments as a clinical-stage biopharmaceutical company developing small-molecule therapies for genetically defined rare diseases and rare hematological disorders. Its lead clinical program, pociredir, is designed to increase fetal hemoglobin for the treatment of sickle cell disease, and company updates commonly address PIONEER trial data, markers of hemolysis and anemia, and sickle cell disease collaborations.
FULC news also covers quarterly financial results, corporate presentations, Nasdaq inducement equity grants, board composition, and updates to the company's pipeline and financial position as it advances small molecules that modulate gene expression.
Fulcrum Therapeutics appointed Dr. Christopher J. Morabito as Chief Medical Officer, effective May 10, 2021. Dr. Morabito brings over 20 years of experience in the biotechnology sector, focusing on advancing clinical programs for rare diseases, including facioscapulohumeral dystrophy (FSHD) and hemoglobinopathies such as sickle cell disease. His previous roles include leadership positions at Cardurion Pharmaceuticals and Takeda. The company aims to leverage his expertise to enhance its clinical pipeline and drug development initiatives.
Fulcrum Therapeutics (Nasdaq: FULC) announced that it will release its first quarter 2021 financial results on May 6, 2021, prior to market opening. A conference call and webcast are scheduled for 8:00 a.m. ET to discuss these results and the company's recent developments. Fulcrum is focused on treating genetically defined rare diseases, with its lead product, losmapimod, in Phase 2 clinical trials for facioscapulohumeral dystrophy (FSHD) and FTX-6058 in Phase 1 trials for sickle cell disease and beta-thalassemia.
Fulcrum Therapeutics (Nasdaq: FULC) has initiated dosing in its Phase 1 trial of FTX-6058, an orally bioavailable EED inhibitor targeting hemoglobinopathies like sickle cell disease and β-thalassemia. The trial is assessing the safety, tolerability, and pharmacokinetics of FTX-6058.
Preclinical results indicate a potential increase in fetal hemoglobin (HbF) levels of up to 30%. The company plans to report data from this trial mid-year and initiate a clinical trial in sickle cell patients by the end of 2021.
Fulcrum Therapeutics, a biopharmaceutical firm focused on genetically defined rare diseases, has appointed Dr. Judith A. Dunn as President of Research and Development. Dr. Dunn brings over 25 years of experience in global drug development, previously serving as Vice President at Roche. Her expertise will support Fulcrum's losmapimod and FTX-6058 programs. The company aims to advance these programs, including two INDs in the next 24 months, leveraging its proprietary FulcrumSeek platform for drug target identification.
Fulcrum Therapeutics (Nasdaq: FULC) announced new data on imaging biomarkers and clinical assessments for facioscapulohumeral muscular dystrophy (FSHD) at the 2021 MDA Conference. Whole body musculoskeletal MRI (WB-MSK-MRI) provides vital information on disease severity. FSHD-TUG, a mobility assessment, shows correlation with clinical outcomes. The company is on track to report data from its Phase 2b ReDUX4 trial for losmapimod in late 2Q 2021. This clinical development aims to improve treatment options for FSHD, a condition affecting approximately 16,000 to 38,000 patients in the U.S.
Fulcrum Therapeutics reported a net loss of $17.7 million in Q4 2020, compared to $16.1 million in Q4 2019, and a total annual net loss of $70.8 million, down from $82.7 million in 2019. The company raised $50.6 million in gross proceeds from a public offering in January 2021, extending its cash runway into Q4 2022. Significant milestones are anticipated in 2021, including data releases from the Phase 2b trial of losmapimod in FSHD and Phase 1 trial of FTX-6058 for sickle cell disease. Fulcrum is discontinuing its Phase 3 COVID-19 trial to focus on rare diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announces leadership changes effective March 31, 2021. Bryan E. Stuart, the current COO, will succeed Robert J. Gould, Ph.D., who is retiring but will remain on the Board as an advisor. Mark Levin will become executive chair. Stuart brings over 20 years of experience in rare diseases, and his leadership is expected to drive growth in Fulcrum’s clinical programs. Currently, Fulcrum is advancing therapies for facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease.
Fulcrum Therapeutics (Nasdaq: FULC) recognizes Rare Disease Day 2021, emphasizing the importance of community support for those affected by rare diseases, especially during COVID-19. The company highlights challenges faced by patients with facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease (SCD) while announcing initiatives to raise awareness and foster connections within the rare disease community. Fulcrum's ongoing clinical developments include losmapimod for FSHD and FTX-6058 for SCD. The press release also underscores the absence of approved therapies for these conditions.
Fulcrum Therapeutics (Nasdaq: FULC) will announce its Q4 and full year 2020 financial results on March 4, 2021, prior to U.S. market opening. A conference call and webcast will follow at 8:00 a.m. ET to discuss the results and company updates. Fulcrum is advancing its proprietary product engine aimed at treating genetically defined rare diseases, with notable developments including losmapimod in Phase 2 for FSHD and Phase 3 for COVID-19, alongside FTX-6058 in Phase 1 for sickle cell disease.
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focused on genetically defined rare diseases, announced its upcoming participation in two virtual investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is scheduled for February 25, 2021, at 10:40 a.m. ET. The H.C. Wainwright Global Life Sciences Conference will feature a prerecorded fireside chat on March 9, 2021, at 7:00 a.m. ET. Audio webcasts will be accessible through the Investor Relations section of the Fulcrum website for 90 days after each event.