Trinity Biotech Plc Stock Price, News & Analysis

Trinity Biotech (Nasdaq: TRIB) received a 9 million-unit order for its WHO-prequalified TrinScreen HIV rapid test, with fulfillment planned in Q4 2025 and Q1 2026. The company reported Q3 2025 revenue $14.3M (+32% vs Q2 2025), gross profit $6.5M, gross margin rising to 45.2%, and Adjusted EBITDA $0.5M (vs -$2.1M in Q2 2025). Trinity cites WHO approval for outsourced manufacturing and expects further Adjusted EBITDA improvement in Q1–Q2 2026 as its Comprehensive Transformation Plan advances. Management promoted Paul Murphy to Interim CFO.

Trinity Biotech (Nasdaq: TRIB) announced expanded regulatory clearances and a wider rollout of its next‑generation high‑capacity HbA1c column system for the Premier Hb9210 analyzer, now available in more than 10 countries, including the United States.

The upgraded column offers up to 4x testing capacity, improved stability, reduced maintenance and a software update that automates routine tasks, which the company says supports higher throughput, recurring revenue potential and margin expansion in a global HbA1c market currently > $2B and forecast to exceed $3.5B by 2030.

Trinity Biotech (Nasdaq: TRIB) announced on November 18, 2025 that it received World Health Organization (WHO) approval for offshored and outsourced upstream manufacturing of its Uni-Gold™ HIV rapid test. The approval permits transitioning upstream production from in-house to outsourced offshore partners after ~two years of development. Management said the change is part of a broader transformation to streamline operations and is expected to improve gross margins, EBITDA and cashflow. The company plans to implement the new Uni-Gold™ manufacturing model in the coming months while retaining regulatory compliance and product integrity.

Trinity Biotech (Nasdaq: TRIB) announced a strategic collaboration with a bioinformatics partner to apply advanced analysis to clinical trial data for EpiCapture, its PCR-based epigenetic liquid biopsy for monitoring progression to high-grade prostate cancer.

The test, described as non-invasive, detects DNA methylation patterns and is in late-stage development aimed at regulatory approval and commercialization; a published study reported that EpiCapture correctly predicted all high-grade cancers when used with PSA. Trinity will leverage its New York State certified reference laboratory to support development and submission activities.

Trinity Biotech (Nasdaq: TRIB) on October 27, 2025 welcomed an indicated proposal from its largest investor and primary lender, Perceptive Advisors, to convert a portion of outstanding debt and other obligations into equity.

The company said the proposed equitization, if implemented, could strengthen the balance sheet, enhance financial flexibility and support its growth objectives while the company engages in discussions with Perceptive and other stakeholders. The release also reiterates standard forward-looking statement cautions and lists risks that could affect outcomes.

Trinity Biotech (Nasdaq: TRIB) has successfully regained compliance with two crucial Nasdaq listing requirements. The company has met the $1.00 per share minimum bid price requirement by maintaining a closing bid price at or above $1.00 for ten consecutive business days from August 12-25, 2025. Additionally, Trinity Biotech has satisfied the minimum market value of publicly held shares (MVPHS) requirement by maintaining an MVPHS of $15 million or greater for more than 10 consecutive business days.

This development resolves the compliance issues that arose on March 14, 2025, when the company received notices from Nasdaq regarding its failure to meet both requirements. While Trinity Biotech has regained compliance, the company acknowledges there is no assurance of maintaining these requirements in the future.

Trinity Biotech (Nasdaq: TRIB), a commercial-stage biotechnology company specializing in human diagnostics and diabetes management solutions, has appointed Paul Tivnan as a Non-Executive Director to its Board of Directors. Tivnan brings over 25 years of senior leadership experience in finance, capital markets, and corporate governance.

Currently serving as CFO of Deriva Energy LLC, Tivnan's notable experience includes leading Ardmore Shipping Corporation's NYSE IPO in 2013 as CFO. He holds multiple professional qualifications including being a Fellow of the Institute of Chartered Accountants of Ireland and a Certified International Director from INSEAD Business School.

The appointment aligns with Trinity Biotech's transformation strategy and focus on growth in diagnostics and wearable health technologies.

Trinity Biotech (Nasdaq: TRIB) has received regulatory approval to begin offshore and outsourced manufacturing of its flagship TrinScreen™ HIV rapid test. This strategic manufacturing transition follows a previous World Health Organization (WHO) approval and represents a crucial milestone in the company's transformation strategy.

The new manufacturing model is designed to deliver three key benefits: expanded gross margins, freed up working capital, and reduced fixed costs. The company has already initiated manufacturing under this new operational framework, which aims to maintain product integrity and regulatory compliance while improving cost-effectiveness and scalability.

Trinity Biotech (Nasdaq: TRIB) has received New York State Department of Health (NYSDOH) approval to launch its FDA-cleared PreClara™ Ratio biomarker test for preeclampsia risk assessment in Q3 2025. The test measures sFlt-1/PlGF ratio to evaluate progression risk to severe preeclampsia in hospitalized patients with hypertensive pregnancy disorders.

The test addresses a significant medical need, as approximately 500,000 U.S. women are affected annually by hypertensive pregnancy disorders. Recent studies show potential cost savings exceeding $10 million per 1,000 patients through reduced preterm deliveries and NICU admissions. This approval also supports the future launch of PrePsia™, Trinity's early pregnancy risk assessment technology.