Latest Biotechnology News

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Vitrafy Life Sciences has announced the completion of Phase II testing of a platelet cryopreservation study with the U.S. Army Institute of Surgical Research, showing consistent results for the legacy wash-based protocol and encouraging outcomes for an innovative no-wash approach.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

Memphasys Limited (ASX: MEM) announced an investor webinar and released an updated presentation detailing its transition from early-stage commercialisation to scaling global revenues, highlighting multi-market sales, recurring cartridge revenue, and regulatory progress.

Arovella Therapeutics has demonstrated that its novel CLDN18.2-targeting CAR incorporated into iNKT cells effectively eliminates pancreatic and gastric cancer cells in vitro, with IL-12-TM armouring enhancing potency and durability.

AdAlta’s BZDS1901 CAR-T therapy shows remarkable tumour shrinkage and complete responses in advanced mesothelioma patients, doubling expected outcomes and paving the way for higher dosing and expanded trials.

Actinogen Medical has initiated the open-label extension of its XanaMIA Alzheimer’s trial, offering all participants active Xanamem treatment for up to 25 months to gather long-term safety and efficacy data ahead of final trial results.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Paradigm Biopharmaceuticals has achieved 50% patient enrolment in its pivotal Phase 3 trial for injectable pentosan polysulfate sodium, advancing steadily towards an interim analysis expected in August 2026.

Patrys Limited is advancing a proprietary injectable formulation of quetiapine aimed at the large and underserved delirium treatment market, leveraging an accelerated FDA approval pathway and extensive existing safety data.

Genetic Technologies Limited remains under voluntary administration with minimal cash outflows and $0.276 million in cash as it navigates its Deed of Company Arrangement.