Atsena Therapeutics Announces Alignment With FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)
UF startup Atsena Therapeutics received FDA approval to expand its Phase 1/2 LIGHTHOUSE study of ATSN-201 into a pivotal Phase 1/2/3 trial to support a BLA submission for treating X-linked retinoschisis (XLRS).
Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy To Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Solid Biosciences, which acquired UF startup AavantiBio, announced FDA and Health Canada approval to begin clinical trials of SGT-501, a gene therapy targeting CPVT, a severe heart rhythm disorder caused by RYR2 mutations.
Myosin Therapeutics Receives FDA Clearance To Initiate First-in-Human Trial of MT-125 in Glioblastoma
UF startup Myosin Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for MT-125.
Atsena Therapeutics Granted U.S. FDA Fast Track Designation for ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATSN-201 for the treatment of X-linked retinoschisis (XLRS).
Myosin Therapeutics Closes Second Seed Round To Advance Clinical Trials for Innovative Cancer and Neuroscience Therapies
UF startup Myosin Therapeutics, Inc., a biotechnology company developing novel therapies for cancer and neurological disorders, has closed its second seed funding round, raising over $3 million to supplement significant investment from the National Institutes of Health.
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Solid Biosciences Inc., a life sciences company that acquired UF startup AavantiBio, announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-212, the Company’s, AAV-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA).
Rise Therapeutics Receives FDA IND Clearance To Initiate Clinical Testing of R-5780 in Cancer
UF startup Rise Therapeutics announced that the U.S. FDA has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780.
Solid Biosciences Announces FDA IND Clearance for First-in-Industry Dual Route of Administration Gene Therapy To Treat Both Neurologic and Cardiac Manifestations of Friedreich’s Ataxia
Solid Biosciences Inc., a biotechnology company that acquired UF startup AavantiBio, announced that the U.S. FDA has cleared its Investigational New Drug application for SGT-212 for the treatment of Friedreich’s ataxia.
Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®
UF startup Axogen, Inc., a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®.
Atsena Therapeutics Receives Rare Pediatric Disease Designation From the U.S. FDA for ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation (RPD) for ATSN-201 for the treatment of X-linked retinoschisis (XLRS).