Latest Biotechnology News

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.

PYC Therapeutics has escalated dosing to the highest level in its Phase 1a trial of PYC-003 and begun dosing patients with Polycystic Kidney Disease, marking key progress toward regulatory milestones.

Nyrada’s Phase I clinical trial for Xolatryp™ concludes with positive safety and pharmacokinetic results, paving the way for a Phase IIa study in acute myocardial infarction patients.

Amplia Therapeutics reports encouraging interim results from its ACCENT trial, with its drug narmafotinib improving progression-free survival and response rates in advanced pancreatic cancer.

Vitrafy Life Sciences reported a 75% increase in FY25 sales driven by aquaculture and human health sectors, progressing its cryopreservation technology towards commercialisation in both unregulated and regulated markets in FY26.

Zoono Group Limited has closed its recent rights issue, raising $785,000 with a significant shortfall remaining. Managing Director Paul Hyslop fully subscribed and may provide further financial support as the company targets growth in Asia and product innovation.

Immutep has received encouraging feedback from the FDA on its immunotherapy eftilagimod alfa combined with KEYTRUDA for patients with low PD-L1 expression in head and neck cancer, opening potential accelerated approval pathways.

Vitrafy Life Sciences reported strong FY25 progress with 75% sales growth, advanced cryopreservation technology development, and a robust cash position. The company outlines a clear commercialisation roadmap for FY26, including product launches and expanded U.S. operations.

Vitrafy Life Sciences reported a $32.7 million loss for FY25, driven by investments in its next-generation cryopreservation platform following a $35 million IPO and a $4.8 million government grant. The company is progressing commercialization efforts with key partnerships in human and animal health.