Latest Therapeutics News

Chimeric Therapeutics has raised $6.6 million through a discounted two-tranche placement to accelerate its promising CAR-T and NK cell therapy clinical programs. The capital raise, strongly backed by institutional and professional investors, signals growing confidence in the company’s oncology pipeline.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

LTR Pharma has expanded patient access to its fast-acting erectile dysfunction treatment SPONTAN by partnering with TerryWhite Chemmart’s extensive pharmacy network, marking a significant step in its commercial rollout and regulatory strategy.

ITM Isotope Technologies Munich SE and Radiopharm Theranostics have entered a strategic supply agreement for the critical radioisotope Lutetium-177, underpinning Radiopharm’s clinical development of targeted cancer therapies.

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.