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Myosin Therapeutics Receives FDA Clearance to Initiate First-in-Human Trial of MT-125 in Glioblastoma

  • Myosin Therapeutics announced on June 9, 2025, that the FDA accepted its IND application to start a first-in-human trial of MT-125 for glioblastoma in Jupiter, Florida.
  • This clearance followed Myosin's rapid program development with Mayo Clinic to address glioblastoma, an aggressive, treatment-resistant cancer with limited advances in two decades.
  • MT-125 selectively inhibits non-muscle myosin II, a protein driving tumor growth, therapy resistance, oxidative stress, and immune evasion, targeting patients with poor chemotherapy responsiveness.
  • The drug has Orphan Drug Designation and showed potent preclinical anti-tumor activity while enhancing radiotherapy efficacy, with Valerie Ahmuty noting the FDA's "rapid and comprehensive review."
  • The FDA acceptance enables a Phase 1 trial combining MT-125 with standard radiation in newly diagnosed glioblastoma patients, highlighting a critical step toward potential new treatment options.
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Myosin Therapeutics Receives FDA Clearance to Initiate First-in-Human Trial of MT-125 in Glioblastoma

JUPITER, Fla., June 9, 2025 /PRNewswire/ -- Myosin Therapeutics, Inc., a clinical-stage biotechnology company developing first-in-class therapies targeting molecular motors, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for…

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PR Newswire broke the news in United States on Monday, June 9, 2025.
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