Latest Gene Therapy 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.

Cryosite Limited reported a robust half-year with revenue up 25% and net profit rising 36%, driven by strong demand in temperature-controlled logistics and a strategic warehouse acquisition that doubles its storage capacity.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

CSL Limited reported a sharp 80% drop in net profit for the half year ended December 2025, driven by significant restructuring and impairment charges, yet maintained its growth guidance and dividend payout.

CSL Limited announces the retirement of CEO Dr Paul McKenzie, with veteran executive Gordon Naylor appointed as interim CEO and Managing Director. The leadership change marks a new chapter for the biotech giant amid ongoing strategic transformation.

Vitrafy Life Sciences has delivered key milestones in the first half of FY26, including a strategic partnership with IMV Technologies and progress in clinical studies, while maintaining a strong cash position to support its U.S. expansion and product launches.

AdAlta Limited has launched its 'East to West' cellular immunotherapy operations through a strategic collaboration with Shanghai Cell Therapy Group to co-develop BZDS1901, an innovative CAR-T therapy targeting mesothelioma and other solid cancers. The company also strengthened its balance sheet by raising $2.8 million via private placements and repaying key investment agreements.

Vitrafy Life Sciences has marked significant progress in Q2 FY2026 with a strategic partnership, commercial launch in North America, and advancing clinical trials, underpinning its growth in cryopreservation technology.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Vitrafy Life Sciences has secured a 12-month exclusive partnership with global animal reproduction leader IMV Technologies to co-develop and commercialise next-generation cryopreservation solutions for farm animals and aquaculture.

NeuroScientific Biopharmaceuticals has secured regulatory approval for initial patient treatments under its Special Access Program for StemSmart™ in Crohn’s disease, alongside key executive appointments and a manufacturing partnership to support upcoming clinical trials.

Vitrafy Life Sciences has delivered its first production unit of the next-generation cryopreservation device, advanced its US commercial footprint, and maintained a strong financial position heading into FY2026.