regulatory
confidence high
sentiment positive
materiality 0.85
FDA grants Breakthrough Therapy Designation to TERN-701; Merck acquisition mentioned in press release
Terns Pharmaceuticals, Inc.
- FDA Breakthrough Therapy Designation for TERN-701 in Ph+ CML-CP patients without T315I mutation, previously treated with 2+ TKIs.
- Designation based on CARDINAL Phase 1/2 data: encouraging major molecular response and deep molecular response rates at week 24.
- TERN-701 safety profile: majority of adverse events low grade; low severe adverse events and discontinuations.
- Press release also notes recent agreement for Merck to acquire Terns (Nasdaq: TERN).
- CEO Amy Burroughs cites BTD and Merck deal as potential acceleration to pivotal trial and patients.