Surrozen gets FDA clearance for SZN-8141 IND, triggering $95.1M financing milestone

Surrozen, Inc. said on October 2, 2026 that the FDA had cleared its Investigational New Drug application for SZN-8141, allowing the company to advance the program into clinical development.¹ The clearance took effect after the standard 30-day statutory review window closed.¹

SZN-8141 is described as a bifunctional antibody that acts as both a Wnt agonist and a vascular endothelial growth factor antagonist, designed to be given as an intravitreal injection to treat diabetic macular edema.¹ Surrozen said it plans to dose the first patient in a Phase 1b/2a trial called DUET testing SZN-8141 in DME patients during the fourth quarter of 2026, with early data anticipated in the second half of 2027.¹ The company also intends to pursue the drug for neovascular age-related macular degeneration and is assessing its potential in other retinal vascular conditions.¹

The IND clearance also carries financial significance: it fulfills the second closing condition tied to Surrozen's two-tranche private placement from March 2025.¹ Under the terms of that securities purchase agreement, the second tranche is anticipated to bring in roughly $95.1 million before fees and expenses.¹ That closing is targeted for on or around October 20, 2026, pending standard closing conditions.¹ Surrozen said the funds raised will go toward advancing both SZN-8141 and SZN-8143, as well as general operations.¹

After the closing, Surrozen plans to file a new Form S-3 registration statement with the SEC covering resale of common stock and warrant-related shares issued in the second tranche.¹ Per its registration rights agreement, the company must file that statement within 30 calendar days of the closing.¹