H.C. Wainwright notes that Taysha Gene Therapies (TSHA) has added about $1.2B to its valuation after receiving Breakthrough Therapy designation from the FDA and agreeing on a six-month interim Biologics License Application plan for gene therapy TSHA-102 for the treatment of Rett syndrome. However, Rett specialists who the firm surveyed and spoke to view Taysha’s six-month interim analysis as “directionally useful but insufficient on its own to be considered definitive for projecting patient outcomes,” reports the analyst, who argues that Taysha’s interim pathway “looks faster on paper, but may not translate into a true lead.” In that context, the firm adds that Neurogene’s (NGNE) FDA-cleared 12-month design mitigates the risk of approvability and contends that the FDA alignment, durability focus, and caregiver appeal make Neurogene look “deeply undervalued” compared to Taysha. The firm reiterates a Buy rating and $45 price target on Neurogene shares.
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