Latest Biotechnology News

Amplia Therapeutics has completed recruitment early for its Phase 2a ACCENT trial in advanced pancreatic cancer, reporting encouraging interim results and advancing a second trial with FDA-backed protocol changes.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

Opyl Limited reports strong progress in AI-driven clinical trial optimisation with active commercial initiatives, strategic partnerships, and a planned capital raise to support growth amid tight cash reserves.

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

Zelira Therapeutics has enhanced its financial flexibility through a $1.15 million R&D tax refund and a $1 million At-the-Market equity facility, while progressing FDA trial preparations for its HOPE® 1 autism treatment.

Radiopharm Theranostics has bolstered its cash position with an $8 million placement from Lantheus Holdings, now its largest shareholder. New clinical data highlight promising advances in brain metastases detection and HER2-targeted radiopharmaceutical therapies.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

Immutep Limited has dosed the first patient in its pivotal Phase III lung cancer trial and completed enrolments in multiple studies, supported by a robust cash position expected to fund operations through 2026.

Vitrafy Life Sciences reported strong Q3 FY2025 progress, including a successful US Army blood platelet study, a $4.8 million government grant, and strategic US market expansion.

Nyrada Inc. posted a significant $2.46 million loss for H1 FY25, driven by increased R&D spend, while advancing its lead drug NYR-BI03 into first-in-human trials following regulatory approval.

Opthea has completed the final patient visit in its pivotal COAST Phase 3 trial evaluating sozinibercept combined with aflibercept for wet AMD, with topline results expected early Q2 2025.

Biome Australia Limited has reported its first-ever net profit of $433,395 for the half-year ended December 2024, alongside a 47.4% increase in revenue driven by strong sales of its Activated Probiotics.