Latest Pharmaceuticals News

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Cambium Bio has secured a strategic partnership with French pharmaceutical leader Benta SAS to commercialise its regenerative dry eye treatment, Elate Ocular, across Europe and the Middle East. This follows a second platelet-lysate licensing deal within days, underscoring growing industry confidence in Cambium’s platform.

Botanix Pharmaceuticals’ ECCLOCK® gel, a treatment for excessive sweating, has secured regulatory approval in South Korea, paving the way for a commercial launch in early 2026.

Acrux Limited has received a $3.04 million R&D Tax Incentive rebate for FY25 and fully repaid its short-term funding facility, underscoring its commitment to Australian pharmaceutical innovation.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Holista Colltech reports a sharp 70% reduction in net loss and an 8.6% revenue rise, driven by strong supplements sales and a landmark collagen partnership with Regenerex Pharma.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.

Unith Ltd reported a 19% revenue increase to $5.37 million for FY25, driven by its new Digital Human platform launch and B2C expansion, yet net losses widened significantly to $4.95 million. The company’s strategic partnerships and capital raise underpin its growth ambitions amid ongoing cash burn.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.