ImageneBio (IMA) FDA Approvals $6.00 -0.01 (-0.17%) Closing price 04:00 PM EasternExtended Trading$6.00 +0.00 (+0.08%) As of 04:10 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 FilingsTrendsBuy 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.. 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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
