regulatory
confidence high
sentiment positive
materiality 0.70
Surrozen wins FDA clearance for SZN-8141 IND; $95.1M second closing milestone triggered
Surrozen, Inc./DE
- FDA cleared Surrozen's IND for SZN-8141, a bifunctional Wnt agonist and VEGF antagonist antibody given as an intravitreal injection for diabetic macular edema (DME).
- First patient dosing in the Phase 1b/2a DUET study in DME expected in Q4 2026, with initial data expected in the second half of 2027.
- IND clearance satisfies the second closing milestone of the March 2025 two-tranche private placement; ~$95.1M in gross proceeds expected on or about October 20, 2026.
- Proceeds will support SZN-8141, SZN-8143 and broader operations; an S-3 resale registration must be filed within 30 days of closing.
- Surrozen also plans to develop SZN-8141 in neovascular age-related macular degeneration and is evaluating other retinal vascular diseases.