Latest Therapeutics News

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Chimeric Therapeutics reports encouraging interim results from its ADVENT-AML Phase 1B trial, with two of three newly diagnosed AML patients achieving remission using their novel CORE-NK cell therapy combined with standard treatment.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Amplia Therapeutics reports a significant milestone in its ACCENT trial, with 15 confirmed partial responses indicating that narmafotinib combined with chemotherapy outperforms chemotherapy alone in advanced pancreatic cancer.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

PolyNovo has secured Therapeutic Goods Administration clearance for thicker versions of its NovoSorb MTX product, broadening treatment options for complex wounds in Australia.

Botanix Pharmaceuticals clarifies its lead product Sofdra is unlikely to face price cuts under the proposed US executive order on drug pricing, citing its exclusive US market approval and distinct formulations abroad.

Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.

Vitura Health reports sustained revenue and EBITDA growth in Q3 FY2025, driven by recent acquisitions and operational improvements, positioning the company well for FY2026.

AVITA Medical reported a strong first quarter with revenues up 67% to $18.5 million, driven by expanded commercial sales and new product introductions. Despite a narrower net loss, the company faces ongoing challenges from revenue covenants and macroeconomic pressures.

AVITA Medical reported a robust 67% increase in first quarter 2025 revenue, driven by new product launches and a strategic commercial overhaul, while reaffirming its full-year growth and profitability targets.

Algorae Pharmaceuticals has partnered with Peter MacCallum Cancer Centre to validate AI-predicted drug combinations across multiple cancer types, aiming to accelerate its oncology pipeline development.