Latest Biotechnology News

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.

Microba Life Sciences has voluntarily suspended trading of its shares from 5 June 2026, ahead of a material capital raise and an update on its path to break even, expected by 11 June.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Cynata Therapeutics secures a crucial regulatory green light from the EMA’s Paediatric Committee for its CYP-001 treatment in children with acute graft versus host disease, paving the way for sequential adult and paediatric trials in Europe.

Opthea Limited resumes ASX trading as it pivots to develop OPT-302 for lymphangioleiomyomatosis, outlining a disciplined 18-month staged clinical program backed by A$31.2 million in cash.

Biome Australia has inked a binding deal with Specialty Probiotics Australia to shift its Activated Probiotics manufacturing onshore, aiming to boost gross margins above 65% and streamline working capital within 18 months.

AFC Group Holdings reported a sharp 78% drop in revenue to NZ$161,000 and a net loss of NZ$818,000 for FY2026, but secured shareholder backing and plans to expand its wine portfolio and distribution reach.

Vitrafy Life Sciences has teamed up with Vitalant Innovation Center to tackle the impending gap in red blood cell cryopreservation technology in the US, aiming to replace soon-to-be-discontinued legacy methods and potentially expand into other blood products.

The Takeovers Panel has declined to investigate Skin Elements Limited's allegations of undisclosed investor associations following a $2.5 million placement, after 62 Capital agreed to waive transfer restrictions on placement securities.

Bio-Gene Technology has expanded its capital raise to $2.775 million through a share placement priced at 2.5 cents, attaching options exercisable at 3.5 cents pending shareholder approval.

Imagion Biosystems has secured FDA clearance to proceed with its Phase 1b/2 trial of the MagSense® HER2 Imaging Agent, targeting improved detection of HER2+ breast cancer. Patient recruitment is expected to start in Q3 2026, marking a crucial step toward commercialisation.

Entropy Neurodynamics has successfully dosed all six participants in the first cohort of its Phase 2 trial for TRP-8803, an intravenous psilocin therapy targeting Binge Eating Disorder. The study demonstrated controlled psychedelic responses, setting the stage for a Data and Safety Monitoring Board review and topline results expected in July 2026.