Latest Gene Therapy News

Cryosite Limited delivered robust FY26 results with revenue up 18% to $16.7 million and net profit rising 19%, underpinned by a strategic warehouse acquisition that doubled storage capacity and a cool room expansion.

Vitrafy Life Sciences reported an 80% revenue surge and halved its net loss, buoyed by US military validation and major blood network partnerships. A $32 million capital raise fuels its US commercial expansion and manufacturing scale-up.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Vitrafy Life Sciences has secured A$30 million through an institutional placement to ramp up manufacturing of its Guardion cryopreservation devices and expand US sales operations, with an additional A$2 million sought via a shareholder plan.

Barramundi Limited’s May update reveals a 2.3% adjusted NAV decline, weighed down by CSL’s earnings downgrade and Brambles’ operational setbacks, despite positive contributions from Xero and Credit Corp.

Cryosite Limited delivered a robust 22% revenue increase and 28% EBITDA growth for the ten months to April 2026, powered by expanding clinical trial activity and infrastructure upgrades.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

CSL Limited’s interim CEO Gordon Naylor reveals a downgraded FY26 outlook amid slower growth and announces substantial impairments tied to CSL Vifor assets. Leadership changes and transformation efforts aim to restore momentum.

INOVIQ Limited is on track to complete its EXO-OC™ ovarian cancer screening study by mid-2026 and is accelerating its CAR-exosome therapy program, supported by a strong cash position of A$11.9 million.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

AdAlta, Oribiotech, and Cell Therapies have inked a Memorandum of Understanding to deploy Oribiotech’s IRO automated cell therapy manufacturing platform in Australia and Asia Pacific, aiming to slash costs and boost production speed for CAR-T therapies.

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.