8/103 sources · 3 publishersUpdated Oct 8, 16:31 UTC
Crescent Biopharma receives FDA clearance for IND of CR‑002 ADC
Crescent Biopharma announced that the U.S. Food and Drug Administration cleared its investigational new drug application for CR‑002, a PD‑L1‑targeted topoisomerase inhibitor antibody‑drug conjugate. The company plans to launch the global Phase 1/2 APOLLO trial in the fourth quarter of 2026, enrolling roughly 200 patients with advanced solid tumors. Initial safety and efficacy data are slated for the second half of 2027.
Why it matters
The clearance moves CR‑002 into the clinic, reducing regulatory risk for Crescent’s ADC pipeline and may support a higher valuation, as reflected by a 1.47% pre‑market share rise.
Key facts
- 1The FDA cleared Crescent’s IND application for CR‑002. globenewswire.com
- 2The APOLLO Phase 1/2 trial is planned to begin in Q4 2026. globenewswire.com
- 3The trial will enroll approximately 200 participants. globenewswire.com
- 4Initial clinical data are expected in the second half of 2027. globenewswire.com
- 5CBIO shares were up 1.47% pre‑market. rttnews.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.