FDA fast track – UF Innovate

Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma (PR Newswire)

sooyoungryu — Fri, 24 Oct 2025 18:57:10 +0000

UF startup Myosin Therapeutics 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.

Solid Biosciences Receives FDA Fast Track Designation for SGT-501 First-in-Class Gene Therapy for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

sooyoungryu — Wed, 23 Jul 2025 00:00:00 +0000

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-501, the Company’s novel, AAV-based investigational gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT). SGT-501 will deliver a functional, full-length, codon-optimized copy of the human cardiac calsequestrin (CASQ2) gene to cardiac muscle cells, an approach intended to address the underlying ryanodine receptor (RYR2) instability and calcium dysregulation seen in CPVT, thereby normalizing cardiac rhythm in diastole.

Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. SGT-501 will benefit from this designation through more frequent interactions with the FDA along with the potential to be eligible for priority review.

Genascence Granted FDA Fast Track Designation for GNSC-001 in Patients With Osteoarthritis (OA) of the Knee

sooyoungryu — Tue, 12 Nov 2024 00:00:00 +0000

UF Startup Genascence Corporation (“Genascence”), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for GNSC-001, a potential first-in-class gene therapy for the treatment of patients with osteoarthritis (OA) of the knee.

GNSC-001 is a genetic medicine – a recombinant adeno-associated vector (AAV) expressing an optimized form of interleukin-1 receptor antagonist (IL-1Ra), a naturally occurring protein that blocks interleukin-1 (IL-1) signaling. IL-1 is considered one of the key mediators involved in the pathogenesis of OA, causing inflammation, joint pain, and cartilage destruction. GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected joint.

Morphogenesis’ Skin Cancer Vaccine Gets FDA ‘Fast Track’

Sara Dagen — Thu, 15 Apr 2021 00:00:00 +0000

Tampa company Morphogenesis, a UF startup, has received a “fast track” designation for its skin cancer vaccination from the United States Food and Drug Administration.

Morphogenesis is a clinical-stage biotechnology company that specializes in development of cell and gene therapy products to treat diseases such as cancer. It announced that its lead clinical-stage candidate, a drug called IFx-Hu2.0, will be fast tracked by the FDA to treat patients with advanced skin cancer.