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TeamedOn acquired clinical trial materials and Phase 1/2 data from AGTC for its XLRS gene therapy program (rAAV2tYF-CB-hRS1) in April 2021. The company received Orphan Drug Designation for XLRS in May 2021, which provides 7-year marketing exclusivity post-approval, tax credits for clinical testing, waiver of Prescription Drug User Fees, and FDA regulatory guidance. The prior intravitreal injection approach did not meet efficacy endpoints, but TeamedOn is planning to explore subretinal injection administration, which is expected to have increased likelihood of producing detectable biological activity.
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