Clinical Trial MomentumInitiation of dosing in the pivotal REVEAL Part B cohort combined with the study's planned interim analysis could enable an earlier pivotal topline readout and support a broader regulatory filing if results are positive.
Regulatory ClarityFDA confirmation that limited pediatric safety data could support a broader label for TSHA-102 in young children, contingent on pivotal study success, reduces uncertainty about the drug's addressable market and competitive positioning.
Strategic Control And FundingRegaining full rights to TSHA-102 together with sufficient capitalization to support Phase 3 operations increases strategic flexibility to advance the program independently or pursue value-enhancing partnerships.