Taysha Gene Therapies announced that subsequent to the receipt of Type C meeting feedback from the FDA regarding a registrational path for TSHA-120, the company will discontinue the development of its TSHA-120 program in evaluation for the treatment of giant axonal neuropathy, or GAN. Further, Taysha announced that Astellas Gene Therapies has elected not to exercise its option to obtain an exclusive license to TSHA-120 under the option agreement between Astellas and Taysha. FDA Type C meeting feedback indicated that the FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120. Among other areas of feedback, the FDA also provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.
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