Latest Biotechnology News

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Noxopharm has successfully completed the third dosing phase of its HERACLES trial for SOF-SKN™, confirming safety and moving forward to the highest dose cohort in this pioneering autoimmune drug study.

Cynata Therapeutics has entered a five-year At-the-Market Subscription Agreement with Acuity Capital, enabling access to up to $7.5 million in standby equity capital with full discretion over timing and pricing.

Prescient Therapeutics reported an 11.1% reduction in net loss for FY2025, progressing its lead candidate PTX-100 into Phase 2a trials with FDA Fast Track and Orphan Drug designations, supported by a recent $9.8 million capital raise.

Genetic Technologies Limited reports a 36% increase in half-year losses amid voluntary administration, followed by a recapitalisation and sale of core assets. The company pivots towards new financial services acquisitions under fresh leadership.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.

AdAlta Limited outlines its innovative 'East to West' cellular immunotherapy approach, in-licensing Asian CAR-T assets and progressing clinical trials in Australia to unlock value. The company also seeks partners for its anti-fibrotic and anti-malarial protein therapeutics.

Opthea has successfully settled its Development Funding Agreement, avoiding a potential $680 million liability and securing $20 million in cash. Leadership changes include the CEO and CFO stepping down, with the Chairman assuming CEO duties.

CSL Limited has announced an unfranked ordinary dividend of USD 1.62 per share for the first half of 2025, with payments scheduled in multiple currencies depending on shareholder location.

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

Tryptamine Therapeutics has locked in $2.6 million in non-dilutive funding to fast-track clinical trials of its lead psilocin-based therapy, TRP-8803, targeting binge eating disorder and other conditions.