Nuvation Bio Expands SIGMA Phase 3 Trial and Truist Lifts Target to $13
Nuvation Bio finalized a protocol amendment to expand its SIGMA safusidenib trial into a Phase 3 registrational study, adding grades 2-4 IDH1-mutant astrocytoma patients after standard radiation and temozolomide. Truist raised its price target to $13 from $11 and maintained a Buy rating, citing strong Ibtrozi uptake.
1. Phase 3 Protocol Amendment
On February 9 Nuvation finalized a protocol amendment to its SIGMA study of safusidenib, converting it into a registrational Phase 3 trial. The amendment broadens eligibility to include grades 2 and 3 IDH1-mutant astrocytoma with high-risk features and grade 4 patients post standard radiation or chemoradiation plus temozolomide.
2. Truist Price Target Increase
On January 27 Truist increased its price target for Nuvation Bio shares from $11 to $13 and maintained a Buy rating. The firm highlighted robust uptake of the Ibtrozi franchise, positioning it as the preferred ROS1 inhibitor despite seasonal headwinds.
3. Clinical Pipeline Overview
Nuvation Bio is advancing multiple clinical-stage oncology candidates, including a brain-penetrant mutant IDH1 inhibitor, a ROS1 inhibitor, a BET inhibitor, and a drug-drug conjugate. The company aims to address unmet needs in high-risk cancers through targeted therapies across registrational and early-stage trials.