InMed Pharmaceuticals (INM) FDA Approvals $1.60 +0.92 (+135.05%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$1.69 +0.09 (+5.56%) As of 05/19/2026 07:59 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 InMed Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by InMed Pharmaceuticals (INM). Over the past two years, InMed Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as INM-901. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. INM-901 FDA Regulatory Events INM-901 is a drug developed by InMed Pharmaceuticals for the following indication: To Reduced Alzheimer's-Related Inflammation. 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. New preclinical data - June 24,2025New Preclinical Data Drug: INM-901Announced Date: June 24, 2025Indication: To Reduced Alzheimer's-Related InflammationAnnouncementInMed Pharmaceuticals Inc. announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential as a therapeutic candidate in Alzheimer's disease.AI SummaryInMed Pharmaceuticals Inc. announced promising preclinical data on its drug candidate, INM-901. The study showed that INM-901 significantly reduced inflammation in ex vivo models of neuroinflammation using animal brain tissue treated with lipopolysaccharide (LPS). Key inflammatory markers, such as IL-6, IL-1β, IL-2, and KC/Gro, were reduced, along with a significant decrease in the inflammasome marker NLRP3. This reduction occurred independent of amyloid beta or tau pathology, which are typically associated with Alzheimer’s disease. The findings support the potential of INM-901 as a therapeutic candidate for Alzheimer’s, as it directly targets neuroinflammation—a known factor in neurodegenerative diseases. These results add to the growing evidence that INM-901 could play a significant role in reducing brain inflammation linked to cognitive decline.Read AnnouncementPositive Results - January 21,2025Positive Results Drug: INM-901Announced Date: January 21, 2025Indication: To Reduced Alzheimer's-Related InflammationAnnouncementInMed Pharmaceuticals Inc announces positive results from a long-term in vivo preclinical Alzheimer's Disease ('AD') study.AI SummaryInMed Pharmaceuticals Inc. announced positive results from its long-term in vivo preclinical study for its ocular drug candidate, INM-089, aimed at treating age-related macular degeneration (AMD). The study showed that INM-089, a cannabinoid analog, provides significant neuroprotection by preserving photoreceptor function and improving retinal pigment epithelium integrity. The results highlighted improvements in retinal function and structure, including increased thickness in the outer nuclear layer and decreased buildup of extracellular deposits—a hallmark of dry AMD. These encouraging findings suggest that INM-089 could help slow disease progression in patients suffering from dry AMD, which affects the majority of those with the condition. InMed is now advancing its next steps, including scaling up manufacturing processes and refining drug formulations, with the goal of moving toward clinical trials and, ultimately, providing a new treatment option for this prevalent and currently limited-to-treat eye disease.Read Announcement InMed Pharmaceuticals FDA Events - Frequently Asked Questions Has InMed Pharmaceuticals received FDA approval? As of now, InMed Pharmaceuticals (INM) has not received any FDA approvals for its therapy in the last two years. What drugs has InMed Pharmaceuticals submitted to the FDA? In the past two years, InMed Pharmaceuticals (INM) has reported FDA regulatory activity for INM-901. What is the most recent FDA event for InMed Pharmaceuticals? The most recent FDA-related event for InMed Pharmaceuticals occurred on June 24, 2025, involving INM-901. The update was categorized as "New preclinical data," with the company reporting: "InMed Pharmaceuticals Inc. announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential as a therapeutic candidate in Alzheimer's disease." What conditions do InMed Pharmaceuticals' current drugs treat? Currently, InMed Pharmaceuticals has one therapy (INM-901) targeting the following condition: To Reduced Alzheimer's-Related Inflammation. 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FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex 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 CDT Equity FDA Events Genprex FDA Events Liminatus Pharma FDA Events Addex Therapeutics FDA Events NuCana FDA Events Portage Biotech FDA Events Brainstorm Cell Therapeutics FDA Events BioAtla FDA Events Heatwurx FDA Events Alaunos Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:INM last updated on 6/24/2025 by MarketBeat.com Staff. 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New preclinical data - June 24,2025New Preclinical Data Drug: INM-901Announced Date: June 24, 2025Indication: To Reduced Alzheimer's-Related InflammationAnnouncementInMed Pharmaceuticals Inc. announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential as a therapeutic candidate in Alzheimer's disease.AI SummaryInMed Pharmaceuticals Inc. announced promising preclinical data on its drug candidate, INM-901. The study showed that INM-901 significantly reduced inflammation in ex vivo models of neuroinflammation using animal brain tissue treated with lipopolysaccharide (LPS). Key inflammatory markers, such as IL-6, IL-1β, IL-2, and KC/Gro, were reduced, along with a significant decrease in the inflammasome marker NLRP3. This reduction occurred independent of amyloid beta or tau pathology, which are typically associated with Alzheimer’s disease. The findings support the potential of INM-901 as a therapeutic candidate for Alzheimer’s, as it directly targets neuroinflammation—a known factor in neurodegenerative diseases. These results add to the growing evidence that INM-901 could play a significant role in reducing brain inflammation linked to cognitive decline.Read Announcement
Positive Results - January 21,2025Positive Results Drug: INM-901Announced Date: January 21, 2025Indication: To Reduced Alzheimer's-Related InflammationAnnouncementInMed Pharmaceuticals Inc announces positive results from a long-term in vivo preclinical Alzheimer's Disease ('AD') study.AI SummaryInMed Pharmaceuticals Inc. announced positive results from its long-term in vivo preclinical study for its ocular drug candidate, INM-089, aimed at treating age-related macular degeneration (AMD). The study showed that INM-089, a cannabinoid analog, provides significant neuroprotection by preserving photoreceptor function and improving retinal pigment epithelium integrity. The results highlighted improvements in retinal function and structure, including increased thickness in the outer nuclear layer and decreased buildup of extracellular deposits—a hallmark of dry AMD. These encouraging findings suggest that INM-089 could help slow disease progression in patients suffering from dry AMD, which affects the majority of those with the condition. InMed is now advancing its next steps, including scaling up manufacturing processes and refining drug formulations, with the goal of moving toward clinical trials and, ultimately, providing a new treatment option for this prevalent and currently limited-to-treat eye disease.Read Announcement
