Kiora Pharmaceuticals (KPRX) FDA Approvals $2.53 -0.04 (-1.56%) Closing price 04:00 PM EasternExtended Trading$2.55 +0.02 (+0.79%) As of 04:28 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 Kiora Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Kiora Pharmaceuticals (KPRX). Over the past two years, Kiora Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KIO-300. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. KIO-300 FDA Regulatory Events KIO-300 is a drug developed by Kiora Pharmaceuticals for the following indication: in Preclinical Epilepsy Model. 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. Preclinical Data - June 18,2026Preclinical Data Drug: KIO-300Announced Date: June 18, 2026Indication: in Preclinical Epilepsy ModelAnnouncementKiora Pharmaceuticals announced preclinical data showing that KIO-300, part of the company's novel ion channel modulator platform, significantly suppressed seizure-associated electrophysiological activity in an ex vivo temporal lobe epilepsy (TLE) model. The findings were presented in a poster at the Epilepsy Foundation Pipeline Conference taking place June 18-19, 2026, in Leesburg, VA.AI SummaryKiora Pharmaceuticals shared preclinical data showing that KIO-300 strongly reduced seizure-related electrical activity in an ex vivo temporal lobe epilepsy model. The results were presented in a poster at the Epilepsy Foundation Pipeline Conference in Leesburg, Virginia, on June 18-19, 2026. Researchers reported that the effect lasted during both treatment and washout, suggesting the compound stayed active in neural tissue for some time. They also found that KIO-300 did not reduce normal brain signaling, which points to a selective effect on abnormal activity rather than broad nervous system suppression. The company said the work builds on earlier retinal studies in which KIO-300 lowered harmful retinal hyperactivity by about 50%. Based on that science, Kiora is exploring whether its membrane-calming approach may also help in epilepsy. The poster was titled “KIO-300/BENAQ Modulates Epileptiform Activity in an Ex Vivo Hippocampal TLE Model.”Read Announcement Kiora Pharmaceuticals FDA Events - Frequently Asked Questions Has Kiora Pharmaceuticals received FDA approval? As of now, Kiora Pharmaceuticals (KPRX) has not received any FDA approvals for its therapy in the last two years. What drugs has Kiora Pharmaceuticals submitted to the FDA? In the past two years, Kiora Pharmaceuticals (KPRX) has reported FDA regulatory activity for KIO-300. What is the most recent FDA event for Kiora Pharmaceuticals? The most recent FDA-related event for Kiora Pharmaceuticals occurred on June 18, 2026, involving KIO-300. The update was categorized as "Preclinical Data," with the company reporting: "Kiora Pharmaceuticals announced preclinical data showing that KIO-300, part of the company's novel ion channel modulator platform, significantly suppressed seizure-associated electrophysiological activity in an ex vivo temporal lobe epilepsy (TLE) model. The findings were presented in a poster at the Epilepsy Foundation Pipeline Conference taking place June 18-19, 2026, in Leesburg, VA." What conditions do Kiora Pharmaceuticals' current drugs treat? Currently, Kiora Pharmaceuticals has one therapy (KIO-300) targeting the following condition: in Preclinical Epilepsy Model. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Allarity Therapeutics FDA EventsBeam Therapeutics FDA EventsCompugen FDA EventsEnanta Pharmaceuticals FDA EventsKiora Pharmaceuticals FDA EventsNovoCure FDA EventsMerck & Co., Inc. FDA EventsAngioDynamics FDA EventsAvalyn Pharma FDA EventsConnect Biopharma FDA EventsErnexa Therapeutics FDA EventsMIRA Pharmaceuticals FDA EventsNeonc Technologies FDA EventsOcular Therapeutix FDA EventsAvalo 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 Incannex Healthcare FDA Events Estrella Immunopharma FDA Events Metagenomi FDA Events Alterity Therapeutics FDA Events MIRA Pharmaceuticals FDA Events RenovoRx FDA Events Gossamer Bio FDA Events Tevogen Bio FDA Events BioXcel Therapeutics FDA Events INmune Bio FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:KPRX last updated on 6/18/2026 by MarketBeat.com Staff. 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Preclinical Data - June 18,2026Preclinical Data Drug: KIO-300Announced Date: June 18, 2026Indication: in Preclinical Epilepsy ModelAnnouncementKiora Pharmaceuticals announced preclinical data showing that KIO-300, part of the company's novel ion channel modulator platform, significantly suppressed seizure-associated electrophysiological activity in an ex vivo temporal lobe epilepsy (TLE) model. The findings were presented in a poster at the Epilepsy Foundation Pipeline Conference taking place June 18-19, 2026, in Leesburg, VA.AI SummaryKiora Pharmaceuticals shared preclinical data showing that KIO-300 strongly reduced seizure-related electrical activity in an ex vivo temporal lobe epilepsy model. The results were presented in a poster at the Epilepsy Foundation Pipeline Conference in Leesburg, Virginia, on June 18-19, 2026. Researchers reported that the effect lasted during both treatment and washout, suggesting the compound stayed active in neural tissue for some time. They also found that KIO-300 did not reduce normal brain signaling, which points to a selective effect on abnormal activity rather than broad nervous system suppression. The company said the work builds on earlier retinal studies in which KIO-300 lowered harmful retinal hyperactivity by about 50%. Based on that science, Kiora is exploring whether its membrane-calming approach may also help in epilepsy. The poster was titled “KIO-300/BENAQ Modulates Epileptiform Activity in an Ex Vivo Hippocampal TLE Model.”Read Announcement
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