Mainz Biomed (MYNZ) FDA Approvals $1.45 -0.09 (-5.84%) As of 07/2/2026 Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsTrendsBuy This Stock Mainz Biomed's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Mainz Biomed (MYNZ). Over the past two years, Mainz Biomed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ColoAlert. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ColoAlert FDA Regulatory Events ColoAlert is a drug developed by Mainz Biomed for the following indication: In the early detection of cancer. 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 - September 2,2025Provided Update Drug: ColoAlertAnnounced Date: September 2, 2025Indication: In the early detection of cancerAnnouncementMainz Biomed N.V. announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.AI SummaryMainz Biomed N.V., a Swiss molecular diagnostics company, has announced that its non-invasive colorectal cancer screening test, ColoAlert®, received official registration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Now authorized for marketing in the United Kingdom, the test can be offered to patients and healthcare providers across the country. This approval follows its European CE mark and marks a key step in Mainz Biomed’s strategy to expand access to at-home cancer screening. ColoAlert examines a small stool sample for hidden blood and specific DNA markers linked to colorectal cancer and advanced polyps. By enabling testing at home, it aims to increase screening participation and catch cancers earlier. Mainz Biomed plans to collaborate with UK laboratories, distributors and healthcare networks to make the test widely available. The company will also pursue reimbursement agreements, supporting nationwide screening programs and helping detect colorectal cancer sooner.Read AnnouncementProvided Update - August 13,2025Provided Update Drug: ColoAlertAnnounced Date: August 13, 2025Indication: In the early detection of cancerAnnouncementMainz Biomed N.V announced that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.AI SummaryMainz Biomed N.V. announced that ColoAlert®, its non-invasive colorectal cancer screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory authority for medical devices. In Switzerland, screening programs target people aged 50 to 74, who make up about 2.8 million residents or 31.4% of the population. Current options include a fecal immunochemical test every two years or a colonoscopy every ten years. Despite over 13 national programs, participation rates remain below 50%. Following Swissmedic approval and a partnership with a local laboratory, ColoAlert® is ready for launch with no remaining obstacles. The test will be available through the partner’s diagnostic services across Switzerland. ColoAlert® detects tumor DNA and other biomarkers in stool samples with high sensitivity. Mainz Biomed plans to expand access through decentralized laboratory partnerships, aiming to boost early detection and reduce colorectal cancer mortality.Read Announcement Mainz Biomed FDA Events - Frequently Asked Questions Has Mainz Biomed received FDA approval? As of now, Mainz Biomed (MYNZ) has not received any FDA approvals for its therapy in the last two years. What drugs has Mainz Biomed submitted to the FDA? In the past two years, Mainz Biomed (MYNZ) has reported FDA regulatory activity for ColoAlert. What is the most recent FDA event for Mainz Biomed? The most recent FDA-related event for Mainz Biomed occurred on September 2, 2025, involving ColoAlert. The update was categorized as "Provided Update," with the company reporting: "Mainz Biomed N.V. announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom." What conditions do Mainz Biomed's current drugs treat? Currently, Mainz Biomed has one therapy (ColoAlert) targeting the following condition: In the early detection of cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events HUTCHMED FDA EventsRevolution Medicines FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsNeurocrine Biosciences FDA EventsNLS Pharmaceutics FDA EventsVertex Pharmaceuticals FDA EventsAC Immune FDA EventsAptevo Therapeutics FDA EventsHeartBeam FDA EventsCandel Therapeutics FDA EventsCogent Biosciences FDA EventsDesign Therapeutics FDA EventsMoleculin Biotech FDA EventsNovoCure 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 Alaunos Therapeutics FDA Events Dogwood Therapeutics FDA Events Mereo BioPharma Group FDA Events PDS Biotechnology FDA Events Instil Bio FDA Events Lantern Pharma FDA Events Actuate Therapeutics FDA Events Metagenomi FDA Events Alterity Therapeutics FDA Events Estrella Immunopharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MYNZ last updated on 9/2/2025 by MarketBeat.com Staff. 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Provided Update - September 2,2025Provided Update Drug: ColoAlertAnnounced Date: September 2, 2025Indication: In the early detection of cancerAnnouncementMainz Biomed N.V. announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.AI SummaryMainz Biomed N.V., a Swiss molecular diagnostics company, has announced that its non-invasive colorectal cancer screening test, ColoAlert®, received official registration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Now authorized for marketing in the United Kingdom, the test can be offered to patients and healthcare providers across the country. This approval follows its European CE mark and marks a key step in Mainz Biomed’s strategy to expand access to at-home cancer screening. ColoAlert examines a small stool sample for hidden blood and specific DNA markers linked to colorectal cancer and advanced polyps. By enabling testing at home, it aims to increase screening participation and catch cancers earlier. Mainz Biomed plans to collaborate with UK laboratories, distributors and healthcare networks to make the test widely available. The company will also pursue reimbursement agreements, supporting nationwide screening programs and helping detect colorectal cancer sooner.Read Announcement
Provided Update - August 13,2025Provided Update Drug: ColoAlertAnnounced Date: August 13, 2025Indication: In the early detection of cancerAnnouncementMainz Biomed N.V announced that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.AI SummaryMainz Biomed N.V. announced that ColoAlert®, its non-invasive colorectal cancer screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory authority for medical devices. In Switzerland, screening programs target people aged 50 to 74, who make up about 2.8 million residents or 31.4% of the population. Current options include a fecal immunochemical test every two years or a colonoscopy every ten years. Despite over 13 national programs, participation rates remain below 50%. Following Swissmedic approval and a partnership with a local laboratory, ColoAlert® is ready for launch with no remaining obstacles. The test will be available through the partner’s diagnostic services across Switzerland. ColoAlert® detects tumor DNA and other biomarkers in stool samples with high sensitivity. Mainz Biomed plans to expand access through decentralized laboratory partnerships, aiming to boost early detection and reduce colorectal cancer mortality.Read Announcement
