Ethan Markowski

Ethan Markowski from Needham & Company questioned if Taysha expects any FDA pushback on using a six-month interim readout for a BLA filing, especially given a competitor's recent regulatory feedback.

Answer

CEO Sean Nolan stated that Taysha's interim analysis approach is highly data-driven, supported by robust Part A data showing a clear and significant effect at six months, with an 83% responder rate in the high-dose group. He confirmed that discussions with the FDA have been constructive and are focused on refining the analysis details, with no pushback received on the viability of the six-month interim itself.

Ethan Markowski of Needham & Company asked if the PRAME strategy in endometrial cancer would mirror other indications by moving to earlier lines, and if KIMMTRAK's growth in Europe would be driven solely by new country launches.

Answer

Mohammed Dar, an executive, stated there are no current plans to move the endometrial program to earlier lines until more late-line data is generated. Ralph Torbay, Head of Commercial, confirmed that future European growth for KIMMTRAK will be marginal and primarily driven by new country launches due to the very tough reimbursement environment.

Ethan Markowski of Needham & Company inquired if the PRAME strategy for endometrial cancer would mirror other indications by moving to earlier lines, and asked if KIMMTRAK's European growth will depend solely on new country launches.

Answer

Mohammed Dar, an executive, stated there are no current plans to move endometrial to earlier lines until late-line data is generated. Ralph Torbay, Head of Commercial, confirmed that future marginal growth in Europe will primarily be driven by launches in new countries, given the challenging reimbursement environment.