Losmapimod

Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer

Retrieved on: 
Monday, March 18, 2024
Sickle cell disease, University, Medicine, Doctor of Philosophy, Albireo, New Drug Application, Patient, SVP, Research, Losmapimod, Senior, Homocystinuria, Facioscapulohumeral muscular dystrophy, Therapy, DRS, Hereditary angioedema, Drug development, Interim, Boston, Fulcrum, PFIC, DSM-IV codes, Pharmaceutical industry

CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Patrick Horn, M.D., Ph.D., as chief medical officer, effective immediately. Dr. Horn is a seasoned executive with over 20 years of end-to-end drug development experience spanning multiple therapeutic areas, with an emphasis on rare diseases, across both large pharmaceutical and biotech companies. Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development. Together, Drs. Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.

Key Points: 
  • Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development.
  • Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.
  • His most recent role was as the Chief Medical Officer at HemoShear Therapeutics, specializing in rare metabolic diseases.
  • Prior to transitioning to industry, Dr. Horn was a practicing pediatrician at major academic institutions in Chicago.

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, February 27, 2024
Conference call, Cohort, Research, GSK, Fulcrum, Acceleron, REACH, SCD, Conference, Therapy, Collaboration, FSHD, Webcast, Patient, Disease, Losmapimod, Pharmaceutical industry

CAMBRIDGE, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the fourth quarter and full year of 2023 as well as an update to the business.

Key Points: 
  • Collaboration Revenue: Collaboration revenue was $0.9 million for the fourth quarter of 2023 as compared to $0.7 million for the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses were $9.9 million for the fourth quarter of 2023 as compared to $10.1 million for the fourth quarter of 2022.
  • Net Loss: Net loss was $24.8 million for the fourth quarter of 2023 as compared to $26.1 million for the fourth quarter of 2022.
  • ET to review the fourth quarter and full year 2023 recent business highlights and financial results.

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Third Quarter 2023

Retrieved on: 
Tuesday, November 7, 2023
FDA, Research, DSM-IV codes, SCD, FSHD, Investigational New Drug, Conference, D, Losmapimod, Disease, Webcast, Fulcrum, Conference call, Therapy, Patient, Cohort, Pharmaceutical industry, Cryptocurrency, Video game, REACH

CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2023 and provided a business update.

Key Points: 
  • ET today ―
    CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2023 and provided a business update.
  • Collaboration Revenue: Collaboration revenue was $0.8 million for the third quarter of 2023 as compared to $1.2 million for the third quarter of 2022.
  • Net Loss: Net loss was $24.0 million for the third quarter of 2023 as compared to $23.7 million for the third quarter of 2022.
  • ET to review the third quarter 2023 recent business highlights and financial results.

Fulcrum Announces Completion of Enrollment in the Phase 3 REACH Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

Retrieved on: 
Thursday, September 7, 2023
NCT, Losmapimod, MFI, FSHD, ClinicalTrials.gov, Quality, PGIC, RWS, Neuro, Patient, Quality of life, FDA, Therapy, Safety, Pharmaceutical industry, Ascending limb of loop of Henle, REACH

“We are very pleased to have enrolled 260 patients in REACH, our global Phase 3 pivotal clinical trial for patients with FSHD,” said Alex C. Sapir, Fulcrum’s president and chief executive officer.

Key Points: 
  • “We are very pleased to have enrolled 260 patients in REACH, our global Phase 3 pivotal clinical trial for patients with FSHD,” said Alex C. Sapir, Fulcrum’s president and chief executive officer.
  • The trial enrolled 260 patients who were randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or placebo, and will be evaluated over a 48-week treatment period.
  • The primary endpoint of the study is the absolute change from baseline in Reachable Workspace (RWS).
  • Secondary endpoints include muscle fat infiltration (MFI), Patient Global Impression of Change (PGIC), and Quality of Life in Neurological Disorders of the Upper Extremity (Neuro QoL UE).

Fulcrum Therapeutics Provides Business Update and 2023 Outlook

Retrieved on: 
Wednesday, January 4, 2023
Anemia, Food, Therapy, EST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sickle cell disease, Patient, FDA, Losmapimod, Hemolysis, Conference, Cohort, REACH, Management, Pharmaceutical industry, SCD, FSHD, HBF, Fulcrum

CAMBRIDGE, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today outlined its recent accomplishments and expected 2023 milestones.

Key Points: 
  • “We are entering 2023 with a tremendous amount of momentum and expect it to be a productive year for our two clinical programs: FTX-6058 for SCD, and losmapimod for FSHD,” said Robert J. Gould, Ph.D., Fulcrum’s interim president and chief executive officer.
  • “FTX-6058 is a potential best-in-class oral HbF inducer candidate that could address critical gaps in the SCD treatment landscape.
  • We are excited by the levels of HbF induction in our initial doses and look forward to further broadening our understanding of its effect at a higher dose.
  • An archived replay will be available on Fulcrum’s website for 30 days.

Fulcrum Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, December 5, 2022
FSHD, Employment, Hemoglobinopathy, Fetal hemoglobin, Gene expression, Facioscapulohumeral muscular dystrophy, Thalassemia, Fulcrum, Sickle cell disease, Therapy, Losmapimod, Patient, Fine chemical

CAMBRIDGE, Mass., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that the Company granted non-statutory stock options to new employees.

Key Points: 
  • CAMBRIDGE, Mass., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that the Company granted non-statutory stock options to new employees.
  • Fulcrum granted stock options to purchase an aggregate of 400,000 shares of the Company’s common stock to four new employees, pursuant to the Company’s 2022 Inducement Stock Incentive Plan, each as an inducement material to the new employees entering into employment with the Fulcrum Therapeutics in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need.
  • The company’s proprietary product engine, FulcrumSeek™, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Verge Genomics Appoints Diego Cadavid, M.D., as Chief Medical Officer

Retrieved on: 
Tuesday, December 6, 2022
Biotechnology, Technology, Other Health, Health, Pharmaceutical, Health Technology, Other Science, Research, Artificial Intelligence, Science, Clinical Trials, Therapy, Publication, Probability, Armed Forces Institute of Pathology, Fulcrum, Armed Forces Institute of Regenerative Medicine, Central nervous system, Amyotrophic lateral sclerosis, Drug discovery, Neuropathology, Pontifical Xavierian University, Biogen, MS, Genomics, University, Microbiology, Neurology, ALS, Drug development, Verge, Medicine, Facioscapulohumeral muscular dystrophy, SVP, AI, FSHD, Artificial intelligence, Thought, Losmapimod, Multiple sclerosis, UTHSCSA, Georgetown University, Pharmaceutical industry, PIKFYVE, Pathology

Verge Genomics, a clinical-stage, tech-enabled biotechnology company pioneering the use of artificial intelligence (AI) and human data to transform drug discovery, announced today that it appointed Diego Cadavid, M.D., as its first Chief Medical Officer.

Key Points: 
  • Verge Genomics, a clinical-stage, tech-enabled biotechnology company pioneering the use of artificial intelligence (AI) and human data to transform drug discovery, announced today that it appointed Diego Cadavid, M.D., as its first Chief Medical Officer.
  • Before joining Verge, Dr. Cadavid served as Chief Medical Officer of X4 Pharmaceuticals where he led the clinical development of mavorixafor and recently delivered positive phase 3 data.
  • His work included the rapid advance of losmapimod from target identification to proof of concept in Facioscapulohumeral Muscular Dystrophy (FSHD).
  • What stands out to me most, though, is his knack using disruptive innovation to enable disciplined execution, said Alice Zhang, CEO and co-founder of Verge Genomics.

Fulcrum Therapeutics to Participate at Upcoming 2022 BofA Securities Biotech SMID Cap Conference

Retrieved on: 
Thursday, December 1, 2022
FSHD, Fulcrum, Conference, Therapy, Fetal hemoglobin, Patient, Thalassemia, Hemoglobinopathy, Losmapimod, Facioscapulohumeral muscular dystrophy, Gene expression, Sickle cell disease, Fine chemical

CAMBRIDGE,Mass., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in a virtual fireside chat at the 2022 BofA Securities Biotech SMID Cap Conference, on Thursday, December 8, 2022 at 9:10 a.m.

Key Points: 
  • CAMBRIDGE,Mass., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in a virtual fireside chat at the 2022 BofA Securities Biotech SMID Cap Conference, on Thursday, December 8, 2022 at 9:10 a.m.
  • ET
    A live audio webcast will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations .
  • Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need.
  • Fulcrums proprietary product engine, FulcrumSeek, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Fulcrum Therapeutics® Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, November 11, 2022
Facioscapulohumeral muscular dystrophy, Company, Employment, Therapy, Thalassemia, GLOBE, Gene expression, Fulcrum, Patient, Fetal hemoglobin, Sickle cell disease, Hemoglobinopathy, Nasdaq, Losmapimod, FSHD, Pharmaceutical industry

The award was granted as of November 7, 2022, pursuant to the Companys 2022 Inducement Stock Incentive Plan, as an inducement material to new employees entering into employment with Fulcrum Therapeutics in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The award was granted as of November 7, 2022, pursuant to the Companys 2022 Inducement Stock Incentive Plan, as an inducement material to new employees entering into employment with Fulcrum Therapeutics in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Each option has an exercise price of $5.61 per share, the closing price per share of the Companys common stock as reported by Nasdaq on November 7, 2022.
  • Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need.
  • The companys proprietary product engine, FulcrumSeek, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Fulcrum Therapeutics Announces Recent Business Highlights and Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, OLE, Losmapimod, Investigational New Drug, IND, REACH, Merck & Co., Nasdaq, Webcast, HBF, Merck, Investor relations, Conference call, G&A, Therapy, SCD, RWS, HIV disease progression rates, WMS, Maintenance, Conference, Patient, Growth, Pharmaceutical industry, FSHD, Fulcrum

ET today

Key Points: 
  • ET today
    CAMBRIDGE, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2022.
  • Collaboration Revenue: Collaboration revenue was $1.2 million for the third quarter of 2022, as compared to $4.9 million for the third quarter of 2021.
  • Net Loss: Net loss was $23.7 million for the third quarter of 2022, as compared to a net loss of $20.7 million for the third quarter of 2021.
  • ET to discuss its third quarter 2022 recent business highlights and financial results.