I-Mab (NBP) FDA Approvals $1.60 -0.03 (-1.84%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$1.65 +0.05 (+3.37%) As of 09/18/2026 07:53 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 EventsFinancialsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest 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 AbCellera Biologics FDA EventsAquestive Therapeutics FDA EventsHemab Therapeutics FDA EventsAdherex Technologies FDA EventsMIRA Pharmaceuticals FDA EventsNeuroOne Medical Technologies FDA EventsQuince Therapeutics FDA EventsSol-Gel Technologies FDA EventsAbbVie FDA EventsBristol Myers Squibb FDA EventsNuvation Bio FDA EventsAbeona Therapeutics FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsFate 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 Aclaris Therapeutics FDA Events Pharming Group FDA Events 4D Molecular Therapeutics FDA Events Monopar Therapeutics FDA Events Nuvectis Pharma FDA Events CytomX Therapeutics FDA Events Aura Biosciences FDA Events Crescent Biopharma FDA Events Verastem FDA Events Ironwood Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:NBP last updated on 3/9/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our Partners$40,000,000,000,000The national debt just hit 40 trillion dollars, and the U.S. now spends more on interest payments than on its ...American Alternative | SponsoredGold did this exact thing in 1975… [then exploded]In 1975 the Fed raised rates and gold fell 50 percent. Headlines called the gold bull market dead. Instead gol...Golden Portfolio | SponsoredBank of America: 'Digital Dollar Inevitable'Bank of America just revealed your expiration date. In their Bloomberg interview, they didn't just predict the...Decentralized Masters | SponsoredA “bloodbath” Is ComingReports suggest some Silicon Valley billionaires are stockpiling gold, guns, and gas masks - or leaving the co...TradeSmith | SponsoredThe trade I’ve been waiting for since 2011Ross Givens, Director of Research at Traders Agency, is calling for gold to reach $10,000 an ounce this superc...Traders Agency | SponsoredWhy I went to Mount RushmoreA small miner just hit on gold in the hills surrounding Mount Rushmore, thanks to a breakthrough new technolog...Stansberry Research | SponsoredBezos… DOOMEDA single FCC filing hints Elon Musk is planning his biggest project yet - bigger than Tesla, SpaceX, and X com...Paradigm Press | SponsoredWhat Elon Musk did in June 2024In June 2024, Elon Musk faced a problem every AI company was about to hit — how to power a massive AI computer...Behind the Markets | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding I-Mab Please log in to your account or sign up in order to add this asset to your watchlist. Share I-Mab With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
