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).
Atsena Therapeutics Announces Positive Clinical Data From Part A of Phase I/II Trial Evaluating ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis (XLRS)
UF startup Atsena Therapeutics announced positive clinical data results from Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS).
Atsena Therapeutics Granted U.S. FDA Regenerative Medicine Advanced Therapy Designation for ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy designation for ATSN-201 for the treatment of X-linked retinoschisis.
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).
Atsena Therapeutics Initiates Part B of Phase I/II Clinical Trial Evaluating Gene Therapy ATSN-201 To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics, a clinical-stage gene therapy company specializing in genetic medicine to reverse or prevent blindness, has announced the initiation of Part B of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating the subretinal injection of ATSN-201 for treating XLRS.
Atsena Therapeutics Announces Dosing Completed in Part A of Phase I/II Clinical Trial Evaluating Gene Therapy ATSN-201 To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics announced dosing has been completed in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS).
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).
