Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma

JUPITER, Fla., Oct. 22, 2025 /PRNewswire/ -- Myosin Therapeutics, Inc., a clinical-stage biotechnology company developing first-in-class therapies that modulate molecular motor proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MT-125 for the treatment of glioblastoma (GBM).

Fast Track is an FDA program designed to facilitate development and expedite review of drugs that treat serious conditions and address unmet medical needs. This designation benefits patients and drug sponsors by enabling more frequent interactions with the FDA and providing eligibility for rolling review of a marketing application.

"Receiving Fast Track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach to patients with even the most aggressive forms of glioblastoma," said Dr. Courtney Miller, Chief Executive Officer of Myosin Therapeutics. "We are energized by the open communication with the FDA that the Fast Track offers because it will ensure we advance MT-125 as quickly as possible with our patient-centered approach."

MT-125 is a first-in-class dual inhibitor of non-muscle myosin IIA and IIB (NMIIA/IIB). It brings a completely new mechanism of action to a disease where decades of limited progress has built anticipation for genuine therapeutic innovation. By leveraging years of GBM biology research focused on targeting the cellular nanomotor proteins driving tumor cells, MT-125 enables simultaneous tackling of the proliferative and invasive phenotypes of this aggressive primary brain tumor, while improving the efficacy of radiation. A Phase 1/2 trial evaluating safety, pharmacokinetics, and preliminary activity is cleared to proceed (ClinicalTrials.gov: NCT07185880). FDA previously granted Orphan Drug Designation to MT-125 for malignant gliomas, including GBM.

About Myosin Therapeutics
Myosin Therapeutics is a privately held biopharmaceutical company advancing therapies that target cellular nanomotor proteins – specialized molecular machines that convert energy into mechanical work inside cells. The company's lead clinical program, MT-125, is being developed for GBM and other oncology indications. Myosin is based in Jupiter, Florida, and collaborates with leading academic and clinical partners.

Contact: [email protected] 

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SOURCE Myosin Therapeutics Inc.