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Cleo Diagnostics (ASX:COV) — Material Events

ASX:COV · 17 articles in the last 12 months · 100% assessed

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Significant 15 articles Notable 2 articles Not Assessed 0 articles
Major ≥90 Significant 75–89 Notable 50–74 Routine <50 Not assessed
Significant Score 75–89
15
Cleo Diagnostics Unveils 2 Million-Strong U.S. Market for Ovarian Cancer TestMedium
Cleo Diagnostics Expands U.S. Market Opportunity for Ovarian Cancer Test to 2 Million Women Annually
6 Nov 2025 ·Market Update ·85
Cleo Diagnostics Hits Major Milestone in Ovarian Cancer Test TrialMedium
Cleo Diagnostics Completes Key Clinical Trial Milestone for Ovarian Cancer Test
31 Mar 2026 ·Clinical Trial Update ·85
Cleo Diagnostics Advances Ovarian Cancer Test with Strong FDA BackingMedium
Cleo Diagnostics gains positive FDA feedback, advancing ovarian cancer test towards U.S. approval
15 Sept 2025 ·Regulatory Update ·85
Cleo Diagnostics Completes Pivotal Trial Recruitment and Advances Manufacturing for FDA SubmissionMedium
Cleo Diagnostics completes pivotal trial recruitment, advances manufacturing and FDA submission preparations
29 Apr 2026 ·Quarterly Activities Report ·85
Cleo Diagnostics Boosts Ovarian Cancer Test Ahead of FDA PushMedium
Cleo Diagnostics expands biomarker panel and nears manufacturing deal ahead of FDA submission
23 Mar 2026 ·ASX Announcement ·85
Cleo Diagnostics Advances FDA Submission and U.S. Reimbursement Pathway with A$6.2m CashMedium
Cleo Diagnostics advances FDA submission and U.S. reimbursement pathway with A$6.2m cash
29 July 2026 ·Quarterly Activities Report ·85
Cleo Diagnostics Expands U.S. Market and Nears FDA Submission MilestoneMedium
Cleo Diagnostics advances U.S. clinical trial, expands market, raises $5M, and progresses FDA pathway
29 Jan 2026 ·Quarterly Activities Report ·85
Cleo Diagnostics Starts Manufacturing Program with Bio-Techne Ahead of FDA SubmissionMedium
Cleo Diagnostics Starts Manufacturing Program with Bio-Techne Ahead of FDA Submission
28 Apr 2026 ·Regulatory and Manufacturing Update ·85
Cleo Diagnostics Begins Analytical Validation of Ovarian Cancer Test KitsMedium
Cleo Diagnostics begins Analytical Validation of ovarian cancer test kits ahead of FDA submission
3 Sept 2026 ·Regulatory Update ·80
Cleo Diagnostics Advances Ovarian Cancer Test with FDA Backing and Clinical MomentumMedium
Cleo Diagnostics advances ovarian cancer test with positive FDA feedback and strong clinical progress
31 Oct 2025 ·Quarterly Activities Report ·80
Cleo Diagnostics Secures $5M to Propel U.S. Ovarian Cancer Test LaunchMedium
Cleo Diagnostics raises A$5 million to fund U.S. launch and screening test development
18 Dec 2025 ·Capital Raising ·80
Cleo Diagnostics Advances Ovarian Cancer Test with Bio-Techne’s Ella™ PlatformMedium
Cleo Diagnostics selects Bio-Techne's Ella™ platform for ovarian cancer test development
18 Feb 2026 ·ASX Announcement ·80
Cleo Diagnostics Advances FDA Trial Amid Rising Losses and $9.4M Cash BoostMedium
Cleo Diagnostics reports increased loss, advances FDA trial and regulatory milestones for ovarian cancer test
25 Feb 2026 ·Appendix 4D Half-Year Report ·75
Cleo Diagnostics Advances to Analytical Validation Ahead of FDA SubmissionMedium
Cleo Diagnostics Commences Analytical Validation Phase Ahead of FDA Submission
13 July 2026 ·Regulatory Update ·75
Cleo Diagnostics Sets U.S. Reimbursement Stage Ahead of FDA NodMedium
Cleo Diagnostics establishes U.S. reimbursement pathway for ovarian cancer test ahead of FDA clearance
20 May 2026 ·Commercial Strategy Update ·75
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No articles in this tier for the last 12 months.