Latest Clinical Trials News

Opthea has successfully settled its Development Funding Agreement, avoiding a potential $680 million liability and securing $20 million in cash. Leadership changes include the CEO and CFO stepping down, with the Chairman assuming CEO duties.

CSL Limited posted a 14% rise in net profit for FY2025, underpinned by strong immunoglobulin sales and new product launches, while announcing plans to demerge its vaccines business, CSL Seqirus, to sharpen strategic focus.

Regal Asian Investments Limited posted a sharp 92% decline in net profit for FY25 amid volatile Asian markets but maintained a fully franked 6 cent dividend and continued its on-market share buy-back program.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.

Nyrada Inc has responded to ASX inquiries confirming the timely and compliant disclosure of positive safety data from its Phase I clinical trial of Xolatryp. The company detailed the timeline of its awareness and release of information, affirming adherence to continuous disclosure rules.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.

Tetratherix has landed a $3.3 million Australian Government grant to co-fund a $7.4 million project expanding its synthetic polymer production and supporting its US market entry in 2026.

Anatara Lifesciences reported a 35% rise in net loss to $1.95 million for FY25, following pivotal Phase II trial results for its GaRP product that missed the primary efficacy endpoint but showed promising secondary benefits. The company is advancing commercialisation efforts and launching a new anti-obesity project amid tightened cash reserves.

Recce Pharmaceuticals’ RECCE 327 Topical Gel shows statistically significant superiority over standard antibiotics in treating antibiotic-resistant burn wounds in preclinical models, advancing its U.S. Department of Defense collaboration.

Opyl Limited has formalized its partnership with UK-based Innovatrix Capital, positioning its AI platform TrialKey at the forefront of clinical trial failure insurance. This deal not only validates Opyl’s technology but also opens doors to global biotech markets and valuable data streams.

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.

Anteris Technologies Global Corp. reported a $42.7 million net loss for the first half of 2025 amid advancing preparations for its pivotal DurAVR Transcatheter Heart Valve trial. The company’s recent IPO proceeds are fueling R&D and manufacturing scale-up as it targets regulatory approvals.