Latest Clinical Development News

Recce Pharmaceuticals has gained key regulatory and ethics approvals for its Phase 3 clinical trial in Indonesia and completed patient dosing for its Phase II trial, while securing a substantial A$6.75 million R&D tax rebate to bolster its financial position.

Paradigm Biopharmaceuticals has launched a Loyalty and Piggyback Options program aimed at rewarding shareholders and raising up to $111.96 million to support its pivotal Phase III clinical trial.

Prescient Therapeutics has secured FDA clearance for its PTX-100 Phase 2 trial targeting relapsed/refractory cutaneous T-cell lymphoma, while also appointing James McDonnell as its new CEO. The company reports steady progress in its cell therapy platforms and maintains a solid cash position bolstered by a recent R&D tax rebate.

Tissue Repair Limited reports initial patient enrolment in its pivotal Phase 3 trial for TR987®, alongside a robust 35% quarterly sales increase for its TR Pro+® product. The company is also advancing manufacturing and distribution strategies to support growth.

Chimeric Therapeutics has dosed the first three patients in its Phase 1/2 CHM CDH17 CAR-T trial targeting gastrointestinal cancers, alongside advancing its AML and NK cell therapy programs. The company also secured $5 million in funding and appointed Dr Rebecca McQualter as CEO.

Vectus Biosystems reports completion of Phase Ib trials for its lead drug VB0004 and a robust cash position bolstered by a significant R&D tax refund, setting the stage for licensing discussions.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for Autosomal Dominant Optic Atrophy, marking a pivotal step in developing a treatment for this currently untreatable blinding disease.

Race Oncology has advanced its Phase 1 clinical trial for RC220, submitting ethics approvals and bolstering its cash reserves to $18.78 million following a $5.25 million R&D tax incentive.

AdAlta Limited has bolstered its leadership team and progressed its 'East to West' cellular therapy strategy alongside its lead drug candidate AD-214, despite a tightening cash position. The company’s recent non-binding term sheet and new clinical data signal promising momentum in its biotech pipeline.

Neurotech International has secured a $2.44 million R&D tax incentive refund, strengthening its cash position as it advances clinical trials for paediatric neurological disorders and prepares for regulatory submissions in FY2025.

Avecho Biotechnology progresses its Phase III clinical trial for a TPM®-enhanced CBD insomnia capsule, expands patient recruitment, and completes a major manufacturing campaign for its U.S. partner Ashland.