Evogene's Drug in the FDA Approval Process
This 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.
- Drug:
- BMC128
- Announced Date:
- June 2, 2026
- Indication:
- Solid cancer tumors
Announcement
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).
AI Summary
Evogene 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.
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Evogene FDA Events - Frequently Asked Questions
As of now, Evogene (EVGN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Evogene (EVGN) has reported FDA regulatory activity for BMC128.
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)."
Currently, Evogene has one therapy (BMC128) targeting the following condition: Solid cancer tumors.
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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
FDA progress for NASDAQ:EVGN last updated on 6/2/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
