Clinical EfficacyPhase 1 ALLOHA updates showing a substantially lower relapse rate for TSC-101–treated patients versus control, along with favorable relapse-free and overall survival trends, strengthen the product’s clinical value proposition.
Manufacturing And Commercial ReadinessAdoption of a 12-day commercial-ready manufacturing process that reduces ex vivo expansion and cost of goods, with early runs indicating robust cell yield, supports scalability for higher dosing and potential retreatment strategies.
Regulatory ClarityFDA alignment on the pivotal trial design and a targeted start in 2Q26 clarify regulatory expectations and materially reduce execution risk for TSC-101's registration path.