Latest Biotechnology News

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.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.

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.

Anatara Lifesciences reported a 35% rise in net loss to $1.95 million for FY25, following pivotal Phase II trial results for its GaRP product that missed the primary efficacy endpoint but showed promising secondary benefits. The company is advancing commercialisation efforts and launching a new anti-obesity project amid tightened cash reserves.

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.

Invex Therapeutics reports a significantly reduced net loss for FY25, driven by lower R&D costs after closing its Phase III trial, while advancing promising pre-clinical Alzheimer’s research through a collaboration with Tessara Therapeutics.

Neuren Pharmaceuticals has added SYNGAP1-related disorder to its NNZ-2591 development program following encouraging pre-clinical findings, targeting a rare condition with no approved treatments.