Surrozen (SRZN) FDA Approvals $29.63 -0.37 (-1.23%) As of 11:48 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest Surrozen's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Surrozen (SRZN). Over the past two years, Surrozen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SZN-8141. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. SZN-8141 FDA Regulatory Events SZN-8141 is a drug developed by Surrozen for the following indication: for the Treatment of Diabetic Macular Edema. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - October 2,2026Provided Update INDDrug: SZN-8141Announced Date: October 2, 2026Indication: for the Treatment of Diabetic Macular EdemaAnnouncementSurrozen, Inc announced its Investigational New Drug (IND) application for SZN-8141 has become effective, enabling the Company to advance the program into clinical development. SZN-8141 is a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody being developed as an intravitreal injection for the treatment of diabetic macular edema (DME).Read Announcement Surrozen FDA Events - Frequently Asked Questions Has Surrozen received FDA approval? As of now, Surrozen (SRZN) has not received any FDA approvals for its therapy in the last two years. What drugs has Surrozen submitted to the FDA? In the past two years, Surrozen (SRZN) has reported FDA regulatory activity for SZN-8141. What is the most recent FDA event for Surrozen? The most recent FDA-related event for Surrozen occurred on October 2, 2026, involving SZN-8141. The update was categorized as "Provided Update," with the company reporting: "Surrozen, Inc announced its Investigational New Drug (IND) application for SZN-8141 has become effective, enabling the Company to advance the program into clinical development. SZN-8141 is a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody being developed as an intravitreal injection for the treatment of diabetic macular edema (DME)." What conditions do Surrozen's current drugs treat? Currently, Surrozen has one therapy (SZN-8141) targeting the following condition: for the Treatment of Diabetic Macular Edema. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsInflaRx FDA EventsCentury Therapeutics FDA EventsObsidian Therapeutics FDA EventsSurrozen FDA EventsVera Therapeutics FDA EventsVerastem FDA EventsJohnson & Johnson FDA EventsTeva Pharmaceutical Industries FDA EventsAktis Oncology FDA EventsAgomAb Therapeutics FDA EventsArtiva Biotherapeutics FDA EventsArvinas FDA EventsBioCardia FDA EventsCandel Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Kailera Therapeutics FDA Events Oric Pharmaceuticals FDA Events Omeros FDA Events Damora Therapeutics, Inc. 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Provided Update - October 2,2026Provided Update INDDrug: SZN-8141Announced Date: October 2, 2026Indication: for the Treatment of Diabetic Macular EdemaAnnouncementSurrozen, Inc announced its Investigational New Drug (IND) application for SZN-8141 has become effective, enabling the Company to advance the program into clinical development. SZN-8141 is a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody being developed as an intravitreal injection for the treatment of diabetic macular edema (DME).Read Announcement
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