Parth Patel

Parth Patel asked about expectations for the 989 readout in front-line MF later this year and what Incyte is looking for to advance the program in that setting.

Answer

Pablo Cagnoni, President and Head of R&D, stated that a substantial dataset in previously untreated myelofibrosis patients will be available by the second half of this year. He expressed confidence that existing 989 efficacy and safety data support first-line MF development, and the upcoming dataset will inform discussions with the FDA on phase 3 trial design.

Parth Patel sought incremental color on expectations for the 989 readout in front-line myelofibrosis (MF) later this year and the criteria for moving forward in that setting.

Answer

Pablo Cagnoni, President and Head of R&D, Incyte, stated that a substantial dataset in previously untreated MF patients would be available by the second half of 2026, including monotherapy and combination with ruxolitinib. He expressed conviction that 989's efficacy and safety, based on existing data, would support first-line MF development, with the new dataset informing Phase III trial design.

Parth Patel, on behalf of Vikram Purohit from Morgan Stanley, asked about the intended design of the upcoming Phase III trial for solriamfetol in MDD with EDS, including study size and key endpoints, and whether this would be the sole additional trial required for a potential filing.

Answer

Herriot Tabuteau, CEO, responded that specific study designs are disclosed upon trial launch. He noted that the design will incorporate learnings from the recently completed proof-of-concept study. He highlighted that the target population of MDD with excessive sleepiness represents about 50% of all MDD patients but did not specify if this would be the only trial needed for approval.

Parth Patel from Morgan Stanley asked about the potential scope of the Phase III development program for KT-621 and how Kymera would prioritize among the broad potential indications.

Answer

CEO Nello Mainolfi stated the plan balances speed and breadth, with the Phase IIb studies informing dose selection for up to eight indications. He expects to prioritize atopic dermatitis and asthma, which are major markets for dupilumab, and likely COPD, before deciding on parallel or staggered development for other indications.