Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Ronde-cel (LYL314) in B-cell lymphoma. The expected timing is based on the latest available company guidance and may change.
PiNACLE trial. Formerly IMPT-314. 6/17/25- Reported new clinical data & presentation at ICML'25. Initiated PiNACLE, single-arm pivotal trial. 9/3/25- Initiated head-to-head trial in 2L setting. 11/3/25- Present new clinical & translational data at ASH'25 on Dec 7, 2025. 11/12/25:- Received RMAT 2L; ASH 2025 oral data; PiNACLE‑H2H first patient early 2026; BLA planned 2027. 12/07/25:- ASH 2025 Ph1/2 data show high ORR/CR in 2L/3L+ R/R LBCL; manageable safety; PiNACLE trials enrolling. 02/12/26:- First patient dosed in PiNACLE‑H2H Ph3; PiNACLE pivotal trial ongoing; BLA submission expected in 2027. 03/12/26:- PiNACLE pivotal data to support BLA expected Mid-2027; cash runway into Q2 2027 supports trials. 05/06/26:- PiNACLE additional data expected H2 2026; pivotal data mid-2027; BLA submission planned 2027. 06/04/26:- EHA 2026 posters June 12 show updated safety/translational data. PiNACLE updated data H2 2026; pivotal data Mid-2027. BLA 2027. 06/12/26:- EHA posters showed safety/translational updates. PiNACLE data H2 2026; pivotal Mid-2027; BLA H2 2027. 08/06/26:- EHA safety updated. PiNACLE data H2 2026, pivotal Mid-2027, BLA H2 2027.
Verification
Confirm timing and program details against the company announcement or filing.