Latest Clinical Trial Data News

Mesoblast Limited reported its first commercial sales of FDA-approved Ryoncil, generating $48.7 million in net product sales for the half-year ended December 31, 2025, while reducing its net loss by 16%. The company also secured a $125 million five-year credit facility, restructuring its debt to support ongoing commercialization and development.

Prescient Therapeutics reported a 62.8% increase in half-year losses to nearly $4 million, driven by intensified clinical development of its PTX-100 cancer therapy. The company bolstered its balance sheet with a $9.85 million capital raise while securing key regulatory milestones in Europe and the US.

Pathkey.AI has completed a strategic review, bolstered its leadership team, and secured $3.5 million in funding to accelerate growth and broaden its AI platform's applications beyond clinical trials.

Little Green Pharma Ltd reported a 9.6% revenue increase to $19.2 million and slashed its net loss by 73% in the half-year ending September 2025, driven by strong growth in European medicinal cannabis markets.

Percheron Therapeutics reports encouraging phase I clinical results for HMBD-002, confirming safety and early efficacy signals, while gearing up for a multi-arm phase II trial in 2026.

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

OncoSil Medical Limited has addressed ASX concerns over delayed disclosure of PANCOSIL clinical trial results, confirming compliance with continuous disclosure obligations despite procedural oversights.

Pathkey.AI’s TrialKey platform continues to validate its AI-driven clinical trial success predictions, with September 2025 seeing an average 43.6% share price increase across flagged biotech stocks.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.

Emyria Limited reports a reduced net loss of $3.14 million for FY2025, driven by strategic expansion in psychedelic-assisted mental health treatments and key partnerships including insurer Medibank. The company advances clinical services while continuing R&D on proprietary medicines.

Cogstate Ltd has reported a strong FY25 with 22% revenue growth and a near doubling of profit before tax, declaring its first fully franked dividend and preparing to launch its inaugural AI-powered product in FY26.