Surrozen, Inc. received U.S. Food and Drug Administration clearance for its Investigational New Drug application for SZN-8141 on October 2, 2026. This regulatory approval allows the company to move the program into clinical trials after the mandatory 30-day review window closed.
The drug candidate is a bifunctional antibody that acts as both a Wnt agonist and a vascular endothelial growth factor antagonist. Surrozen is developing it as an intravitreal injection to treat diabetic macular edema. The company anticipates dosing the first patient in the DUET Phase 1b/2a study during the fourth quarter of 2026. Preliminary results from this trial are projected for the second half of 2027. Beyond diabetic macular edema, Surrozen intends to investigate SZN-8141 for neovascular age-related macular degeneration and other retinal vascular conditions.
The FDA clearance also fulfills a key condition for the second tranche of a private placement agreement established in March 2025. Surrozen expects this second closing to generate roughly $95.1 million in gross proceeds, prior to the deduction of placement agent fees and other costs. The transaction is scheduled to close around October 20, 2026, provided that all relevant closing conditions are met.
The company plans to use these funds to advance the development of SZN-8141 and SZN-8143, along with other general operating needs. After the closing, Surrozen will submit a new Form S-3 registration statement to the U.S. Securities and Exchange Commission. This filing will register the resale of common stock and shares underlying pre-funded warrants and Series E common stock warrants issued in this transaction. A registration rights agreement mandates that this filing be submitted within 30 calendar days of the closing date.