Latest Biotech News

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 posted a 14% rise in net profit for FY2025, underpinned by strong immunoglobulin sales and new product launches, while announcing plans to demerge its vaccines business, CSL Seqirus, to sharpen strategic focus.

Regal Asian Investments Limited posted a sharp 92% decline in net profit for FY25 amid volatile Asian markets but maintained a fully franked 6 cent dividend and continued its on-market share buy-back program.

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.

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.

Nyrada Inc has responded to ASX inquiries confirming the timely and compliant disclosure of positive safety data from its Phase I clinical trial of Xolatryp. The company detailed the timeline of its awareness and release of information, affirming adherence to continuous disclosure rules.

Tetratherix has landed a $3.3 million Australian Government grant to co-fund a $7.4 million project expanding its synthetic polymer production and supporting its US market entry in 2026.

Opyl Limited has formalized its partnership with UK-based Innovatrix Capital, positioning its AI platform TrialKey at the forefront of clinical trial failure insurance. This deal not only validates Opyl’s technology but also opens doors to global biotech markets and valuable data streams.

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.

Syntara Limited is set to update investors on the clinical progress of its lead drug candidate amsulostat, targeting myelofibrosis, in a webinar scheduled for 11 August 2025. The company highlights recent regulatory milestones and advancing trials.

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

Noxopharm Limited has successfully completed the second dose cohort in its HERACLES Phase 1 trial for SOF-SKN™, confirming safety and tolerability and moving forward to a higher dose. This progress marks a key step in developing a novel autoimmune disease treatment.