gotistobart (also known as BNT316 or ONC-392) — Clinical data readout
2026
Pivotal Phase 3 data expected in 2026Source filing
BNTX biotech catalysts & pipeline
BIONTECH SE · Data as of 2026-10-25
Upcoming catalysts
trastuzumab pamirtecan — NDA/BLA submission
2026
While BioNTech and DualityBio plan to file a biologics license application ("BLA") in 2026, the companies will determine the optimal regulatory path for trastuzumab pamirtecan based on the totality of clinical data in endometrial cancer and breast cancer.Source filing
trastuzumab pamirtecan — Clinical data readout
Q4 2026
Based on current event accrual projections, the primary analysis is expected in the fourth quarter 2026.Source filing
Autogene cevumeran (BNT122/RO7198457) — Clinical data readout
2027
Data read-out from the final analysis of this trial has been updated from 2026 to 2027, given that events have accrued more slowly than projected.Source filing
pumitamig (also known as BNT327 or BMS-986545) — Conference presentation
Oct 23–Oct 27
Oct 23 - 27, 2026Source filing
pumitamig (also known as BNT327 or BMS-986545) — Conference presentation
Oct 25
Oct 25, 2026: 8:30 - 10:00am CETSource filing
Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) — Conference presentation
Oct 26
Oct 26, 2026: 12:00 - 12:45pm CETSource filing
pumitamig (also known as BNT327 or BMS-986545) — Conference presentation
Oct 26
Oct 26, 2026: 10:15 - 11:45am CETSource filing