Latest Biotechnology News

Microba Life Sciences secures $5 million in a placement led by Sonic Healthcare to fund its push towards cashflow break-even by 2027, backed by strong diagnostic sales and AI-driven efficiencies.

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.

Neurizon Therapeutics has dosed over 50% of participants in the HEALEY ALS Platform Trial's Regimen I, exceeding recruitment expectations after expanding the cohort from 160 to 240 patients. The accelerated pace puts the company on track for last patient dosing in Q2 2027 and topline results by early Q3 2027.

ReNerve has appointed J4 Biologics as a second manufacturer for its Empliq range to meet growing hospital approvals and market demand, strengthening its supply chain and scaling production capacity.

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.

Syntara Limited has completed a $0.84 million Share Purchase Plan, boosting its total capital raise to $8.84 million to fund multiple clinical trials and patent development through to Q3 2027.

Imugene’s off-the-shelf CAR T therapy azer-cel has won FDA Fast Track Designation for relapsed or refractory CLL/SLL and MZL, backed by compelling Phase 1b response rates.

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.