Evogene (EVGN) FDA Approvals $0.68 -0.02 (-3.12%) Closing price 06/1/2026 04:00 PM EasternExtended Trading$0.60 -0.08 (-11.57%) As of 09:25 AM 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 ForecastsChartCompetitorsEarningsHeadlinesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Evogene's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Evogene (EVGN). Over the past two years, Evogene has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BMC128. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. BMC128 FDA Regulatory Events BMC128 is a drug developed by Evogene for the following indication: Solid cancer tumors. 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. Clinical Study - June 2,2026Clinical Study Phase 1Drug: BMC128Announced Date: June 2, 2026Indication: Solid cancer tumorsAnnouncementEvogene Ltd announced the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd., in combination with Nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).AI SummaryEvogene Ltd. said its subsidiary Biomica successfully finished the first human Phase 1 study of BMC128, a live bacterial therapy tested with nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer. The study met its main safety goal, showing the treatment was well tolerated and caused no dose-limiting toxicities. Early results also suggested possible anti-cancer activity: 5 of 11 patients had stable disease beyond 16 weeks, 2 stayed on treatment through the full two-year follow-up, and 1 patient had a partial response. Researchers also found biological signs that matched the therapy’s planned mechanism, including greater microbiome diversity and immune activation. Based on these findings, Evogene said it is preparing for the next stage of clinical development. The product is now being developed with Lishan Biotech under the name LS-LBP-002.Read Announcement Evogene FDA Events - Frequently Asked Questions Has Evogene received FDA approval? As of now, Evogene (EVGN) has not received any FDA approvals for its therapy in the last two years. What drugs has Evogene submitted to the FDA? In the past two years, Evogene (EVGN) has reported FDA regulatory activity for BMC128. What is the most recent FDA event for Evogene? The most recent FDA-related event for Evogene occurred on June 2, 2026, involving BMC128. The update was categorized as "Clinical Study," with the company reporting: "Evogene Ltd announced the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd., in combination with Nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC)." What conditions do Evogene's current drugs treat? Currently, Evogene has one therapy (BMC128) targeting the following condition: Solid cancer tumors. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Evogene FDA EventsRezolute FDA EventsVera Therapeutics FDA EventsActuate Therapeutics FDA EventsAprea Therapeutics FDA EventsAura Biosciences FDA EventsBriacell Therap FDA EventsCelcuity FDA EventsCellectar Biosciences FDA EventsCitius Pharmaceuticals FDA EventsCytokinetics FDA EventsAlpha Tau Medical FDA EventsEnlivex Therapeutics FDA EventsGreenwich LifeSciences FDA EventsIDEAYA Biosciences 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:EVGN last updated on 6/2/2026 by MarketBeat.com Staff. 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Clinical Study - June 2,2026Clinical Study Phase 1Drug: BMC128Announced Date: June 2, 2026Indication: Solid cancer tumorsAnnouncementEvogene Ltd announced the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd., in combination with Nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).AI SummaryEvogene Ltd. said its subsidiary Biomica successfully finished the first human Phase 1 study of BMC128, a live bacterial therapy tested with nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer. The study met its main safety goal, showing the treatment was well tolerated and caused no dose-limiting toxicities. Early results also suggested possible anti-cancer activity: 5 of 11 patients had stable disease beyond 16 weeks, 2 stayed on treatment through the full two-year follow-up, and 1 patient had a partial response. Researchers also found biological signs that matched the therapy’s planned mechanism, including greater microbiome diversity and immune activation. Based on these findings, Evogene said it is preparing for the next stage of clinical development. The product is now being developed with Lishan Biotech under the name LS-LBP-002.Read Announcement
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