ImageneBio (IMA) FDA Approvals $5.68 -0.23 (-3.89%) As of 01:53 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock ImageneBio's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by ImageneBio (IMA). Over the past two years, ImageneBio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IMG-007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. IMG-007 FDA Regulatory Events IMG-007 is a drug developed by ImageneBio for the following indication: adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive patients. 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 - November 12,2025Provided Update Drug: IMG-007Announced Date: November 12, 2025Indication: adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive patients.AnnouncementImageneBio, Inc. announced financial results for the quarter ended September 30, 2025, and provided an update on its program.AI SummaryImageneBio reported third-quarter 2025 results and an update on its IMG-007 program. The company ended September 30, 2025 with $142.6 million in cash, cash equivalents and marketable securities, largely driven by a merger and a $75 million private placement. Quarterly R&D expense was $15.6 million, G&A $11.0 million, and net loss was $24.8 million. Imagene announced a planned protocol amendment for its ongoing Phase 2b ADAPTIVE trial in moderate-to-severe atopic dermatitis to better match IMG-007’s molecular profile. The amendment aims to broaden dose ranges, evaluate loading doses and patient-friendly dosing intervals, and improve study feasibility. Enrollment at North American sites remains strong and topline data are expected in 2027. Imagene will present Phase 1b/2a data at the ISDS meeting showing a dose-related hair regrowth signal and suppressed scalp inflammatory biomarkers in alopecia areata, and strong EASI improvements in atopic dermatitis. The company also strengthened leadership with new executive hires and a new independent director.Read Announcement ImageneBio FDA Events - Frequently Asked Questions Has ImageneBio received FDA approval? As of now, ImageneBio (IMA) has not received any FDA approvals for its therapy in the last two years. What drugs has ImageneBio submitted to the FDA? In the past two years, ImageneBio (IMA) has reported FDA regulatory activity for IMG-007. What is the most recent FDA event for ImageneBio? The most recent FDA-related event for ImageneBio occurred on November 12, 2025, involving IMG-007. The update was categorized as "Provided Update," with the company reporting: "ImageneBio, Inc. announced financial results for the quarter ended September 30, 2025, and provided an update on its program." What conditions do ImageneBio's current drugs treat? Currently, ImageneBio has one therapy (IMG-007) targeting the following condition: adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive patients.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Belite Bio FDA EventsINmune Bio FDA EventsKymera Therapeutics FDA EventsLigand Pharmaceuticals FDA EventsProtara Therapeutics FDA EventsTenaya Therapeutics FDA EventsUrogen Pharma FDA EventsAardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCelcuity 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 Humacyte FDA Events Adherex Technologies FDA Events I-Mab FDA Events Arcturus Therapeutics FDA Events Alector FDA Events Nkarta FDA Events Keros Therapeutics FDA Events MacroGenics FDA Events Context Therapeutics FDA Events Fate Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:IMA last updated on 11/12/2025 by MarketBeat.com Staff. 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Provided Update - November 12,2025Provided Update Drug: IMG-007Announced Date: November 12, 2025Indication: adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive patients.AnnouncementImageneBio, Inc. announced financial results for the quarter ended September 30, 2025, and provided an update on its program.AI SummaryImageneBio reported third-quarter 2025 results and an update on its IMG-007 program. The company ended September 30, 2025 with $142.6 million in cash, cash equivalents and marketable securities, largely driven by a merger and a $75 million private placement. Quarterly R&D expense was $15.6 million, G&A $11.0 million, and net loss was $24.8 million. Imagene announced a planned protocol amendment for its ongoing Phase 2b ADAPTIVE trial in moderate-to-severe atopic dermatitis to better match IMG-007’s molecular profile. The amendment aims to broaden dose ranges, evaluate loading doses and patient-friendly dosing intervals, and improve study feasibility. Enrollment at North American sites remains strong and topline data are expected in 2027. Imagene will present Phase 1b/2a data at the ISDS meeting showing a dose-related hair regrowth signal and suppressed scalp inflammatory biomarkers in alopecia areata, and strong EASI improvements in atopic dermatitis. The company also strengthened leadership with new executive hires and a new independent director.Read Announcement
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