Latest Biotechnology News

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.

Opthea Limited has terminated its sozinibercept wet AMD program following Phase 3 trial failures and settled a major funding agreement, setting the stage for a strategic reset.

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 reported solid FY25 financials with 5% revenue growth and announced a strategic transformation including a $500 million annual cost saving target and plans to spin off its vaccine business, CSL Seqirus, as a separate ASX-listed entity.

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.

CSL Limited reported robust FY25 results alongside a sweeping strategic overhaul, including a major cost-saving program and plans to spin off its vaccine unit CSL Seqirus as a standalone ASX-listed company.

Rhythm Biosciences has launched a $3.75 million placement alongside an offer of over 52 million new options, all contingent on shareholder approval. The move aims to bolster working capital as the company advances its cancer diagnostic products.

Rhythm Biosciences has announced a $3.75 million placement to accelerate the commercial launch of its ColoSTAT® cancer detection test and expand its geneType™ product suite into key markets. The capital raise includes director participation and attaching options, pending shareholder approval.

Rhythm Biosciences is raising up to $3.75 million through a share placement to fund the launch of its ColoSTAT® colorectal cancer diagnostic and accelerate commercialization of its geneType™ portfolio.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.