tiprankstipranks
The Fly

Oric Pharmaceuticals announces clinical development plans for ORIC-944, ORIC-114

Oric Pharmaceuticals announces clinical development plans for ORIC-944, ORIC-114

Oric Pharmaceuticals (ORIC) announced focused registrational clinical development plans for its two lead programs, an extension of projected cash runway into 2027, and accelerated/augmented corporate milestones. Given the recently reported early safety and efficacy data from an ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer and favorable enrollment trends, Oric now expects to report dose escalation data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in 1H 2025, followed by an additional update in 2H 2025. Expected timing for the previously communicated milestone of ORIC-944 dose optimization data in combination with AR inhibitor has been accelerated/narrowed to 4Q25 or 1Q26. Given favorable enrollment for ORIC-114 in the 1L EGFR exon 20 monotherapy cohort and the 2L+ atypical EGFR cohort, Oric now expects to provide a comprehensive data update during 2H 2025 that will include these two cohorts along with cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20. ORIC-114 in combination with subcutaneous amivantamab in patients with 1L EGFR exon 20 has recently been initiated. Initial data from this trial in addition to ORIC-114 data as a monotherapy in 1L EGFR atypical mutations are expected in mid-2026. Oric expects to initiate Phase 3 trial(s) for ORIC-114 in 1L NSCLC in 2026, in EGFR exon 20, HER2 exon 20, and/or atypical EGFR mutations. Oric does not currently plan to pursue registrational trials of ORIC-114 in 2L EGFR and 2L+ HER2 exon 20 NSCLC given the more significant commercial opportunity in first-line settings and the current state of capital markets. Oric expects to initiate its first Phase 3 trial for ORIC-944 in mCRPC in 1H 2026.

Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

1