other material
confidence medium
sentiment positive
materiality 0.80
Nuvation Bio files 8-K/A with AnHeart financials and updated taletrectinib clinical data
Nuvation Bio Inc.
- Acquired AnHeart in Apr 2024; audited AnHeart FY2023 and FY2022 financials included.
- Taletrectinib TRUST-I: 90.6% cORR in TKI-naive ROS1+ NSCLC; median PFS not reached at 23.5 mo f/u.
- Intracranial cORR 87.5% (TKI-naive) and 73.3% (TKI-pretreated) in TRUST-I; low neuro TEAEs.
- NDA accepted in China with priority review for taletrectinib; Breakthrough Therapy in US and China.
- Innovent out-license: $55M received; up to $29M regulatory + $105M commercial milestones.