Latest Clinical Development News

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Mesoblast has achieved a landmark FDA approval for RYONCIL, the first allogeneic mesenchymal stromal cell therapy, driving strong commercial momentum and advancing a robust pipeline targeting inflammatory diseases.
Ada Torres
Ada Torres
25 Nov 2025
Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.
Ada Torres
Ada Torres
25 Nov 2025
Aroa Biosurgery has reported a strong first half for FY26, with 14% revenue growth driven by its Myriad product line and a return to positive EBITDA. The company also secured relief from ASX quarterly reporting requirements, signaling improved financial stability.
Ada Torres
Ada Torres
25 Nov 2025
Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.
Ada Torres
Ada Torres
25 Nov 2025
PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for PYC-003, an RNA therapy targeting Polycystic Kidney Disease. This milestone moves the drug closer to pivotal Phase 2/3 trials.
Ada Torres
Ada Torres
24 Nov 2025
Alterity Therapeutics announces significant board changes, including the retirement of founding chairman Geoffrey Kempler and appointment of CEO Dr David Stamler as Managing Director, aligning leadership with its Phase 3 clinical ambitions.
Ada Torres
Ada Torres
21 Nov 2025
Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.
Ada Torres
Ada Torres
20 Nov 2025
AFT Pharmaceuticals delivered a robust first half for FY26, posting 33% revenue growth and a return to profitability, driven by strong Australian sales and recovery in Asia and international markets. The company is advancing its global footprint and R&D pipeline, positioning for sustained growth.
Victor Sage
Victor Sage
20 Nov 2025
AFT Pharmaceuticals has reported a robust first half of FY26, posting a 33% revenue increase to a record $114.9 million and returning to profitability amid strong growth in Australia and international markets. The company’s advancing R&D pipeline and strategic licensing deals position it well for ambitious FY27 targets.
Victor Sage
Victor Sage
20 Nov 2025
Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.
Ada Torres
Ada Torres
19 Nov 2025
Tryptamine Therapeutics has enrolled its second patient in a pioneering clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with first dosing scheduled for December and results expected early next year.
Ada Torres
Ada Torres
18 Nov 2025
Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.
Ada Torres
Ada Torres
18 Nov 2025