I-Mab (NBP) FDA Approvals $1.60 -0.01 (-0.62%) Closing price 04:00 PM EasternExtended Trading$1.62 +0.02 (+1.25%) As of 07:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock I-Mab's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by I-Mab (NBP). Over the past two years, I-Mab has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VIS-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. VIS-101 FDA Regulatory Events VIS-101 is a drug developed by I-Mab for the following indication: in patients with wet age-related macular degeneration (wet AMD). 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. Top-line results - March 9,2026Top-Line Results Phase 2aDrug: VIS-101Announced Date: March 9, 2026Indication: in patients with wet age-related macular degeneration (wet AMD).AnnouncementNovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).AI SummaryNovaBridge’s VIS-101 is a tetravalent, dual VEGF‑A × ANG‑2 inhibitor designed for retinal vascular diseases. Topline Phase 2a results in wet AMD showed rapid, robust and durable responses: mean best-corrected visual acuity (BCVA) gains exceeded 10 ETDRS letters, with median central subfield thickness (CST) reductions of about 100–150 µm. Both 3 mg and 6 mg dose cohorts produced meaningful improvements, and the compound demonstrated potentially best‑in‑class durability with a favorable safety profile and no dose‑limiting toxicity. The randomized Phase 2a trial enrolled 38 patients in China (ages 50–80), including treatment‑naïve and pre‑treated participants, randomized 2:1 to 6 mg (n=25) vs 3 mg (n=13). Treatment‑related adverse events were low (0% at 3 mg; 8% at 6 mg). A Phase 2b dose‑determining study is expected in H2 2026, with a global Phase 3 program planned for 2027.Read AnnouncementProvided Update - March 3,2026Provided Update Drug: VIS-101Announced Date: March 3, 2026Indication: in patients with wet age-related macular degeneration (wet AMD).AnnouncementNovaBridge Biosciences announced that it will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD).AI SummaryNovaBridge Biosciences will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD). Investors and the public can register and access the live webcast via the News & Events page on the NovaBridge website; a replay will be archived there for at least 90 days. VIS-101 is a purpose-designed, bispecific, tetravalent dual VEGF-A/ANG-2 inhibitor being developed to provide more potent and durable treatment than current standard care. It is being evaluated for wet AMD and is also intended for diabetic macular edema (DME) and retinal vein occlusion (RVO). The candidate is completing a randomized, dose-ranging Phase 2a study for wet AMD. NovaBridge is the majority shareholder of Visara, which holds global development and commercialization rights to VIS-101 outside of Greater China and certain other Asian territories.Read Announcement I-Mab FDA Events - Frequently Asked Questions Has I-Mab received FDA approval? As of now, I-Mab (NBP) has not received any FDA approvals for its therapy in the last two years. What drugs has I-Mab submitted to the FDA? In the past two years, I-Mab (NBP) has reported FDA regulatory activity for VIS-101. What is the most recent FDA event for I-Mab? The most recent FDA-related event for I-Mab occurred on March 9, 2026, involving VIS-101. The update was categorized as "Top-line results," with the company reporting: "NovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO)." What conditions do I-Mab's current drugs treat? Currently, I-Mab has one therapy (VIS-101) targeting the following condition: in patients with wet age-related macular degeneration (wet AMD).. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Cybin FDA EventsREGENXBIO FDA EventsViking Therapeutics FDA EventsWAVE Life Sciences FDA EventsMerck & Co., Inc. FDA EventsAgomAb Therapeutics FDA EventsAmylyx Pharmaceuticals FDA EventsCoherus Oncology FDA EventsDiaMedica Therapeutics FDA EventsEntera Bio FDA EventsGalectin Therapeutics FDA EventsGilead Sciences FDA EventsJaguar Animal Health FDA EventsKalaris Therapeutics FDA EventsMicrobot Medical 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 Design Therapeutics FDA Events Allogene Therapeutics FDA Events Aura Biosciences FDA Events Climb Bio FDA Events Aclaris Therapeutics FDA Events Bright Minds Biosciences FDA Events Candel Therapeutics FDA Events Gyre Therapeutics FDA Events Tectonic Therapeutic FDA Events Aquestive Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:NBP last updated on 3/9/2026 by MarketBeat.com Staff. 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Top-line results - March 9,2026Top-Line Results Phase 2aDrug: VIS-101Announced Date: March 9, 2026Indication: in patients with wet age-related macular degeneration (wet AMD).AnnouncementNovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).AI SummaryNovaBridge’s VIS-101 is a tetravalent, dual VEGF‑A × ANG‑2 inhibitor designed for retinal vascular diseases. Topline Phase 2a results in wet AMD showed rapid, robust and durable responses: mean best-corrected visual acuity (BCVA) gains exceeded 10 ETDRS letters, with median central subfield thickness (CST) reductions of about 100–150 µm. Both 3 mg and 6 mg dose cohorts produced meaningful improvements, and the compound demonstrated potentially best‑in‑class durability with a favorable safety profile and no dose‑limiting toxicity. The randomized Phase 2a trial enrolled 38 patients in China (ages 50–80), including treatment‑naïve and pre‑treated participants, randomized 2:1 to 6 mg (n=25) vs 3 mg (n=13). Treatment‑related adverse events were low (0% at 3 mg; 8% at 6 mg). A Phase 2b dose‑determining study is expected in H2 2026, with a global Phase 3 program planned for 2027.Read Announcement
Provided Update - March 3,2026Provided Update Drug: VIS-101Announced Date: March 3, 2026Indication: in patients with wet age-related macular degeneration (wet AMD).AnnouncementNovaBridge Biosciences announced that it will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD).AI SummaryNovaBridge Biosciences will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD). Investors and the public can register and access the live webcast via the News & Events page on the NovaBridge website; a replay will be archived there for at least 90 days. VIS-101 is a purpose-designed, bispecific, tetravalent dual VEGF-A/ANG-2 inhibitor being developed to provide more potent and durable treatment than current standard care. It is being evaluated for wet AMD and is also intended for diabetic macular edema (DME) and retinal vein occlusion (RVO). The candidate is completing a randomized, dose-ranging Phase 2a study for wet AMD. NovaBridge is the majority shareholder of Visara, which holds global development and commercialization rights to VIS-101 outside of Greater China and certain other Asian territories.Read Announcement
