Latest Pharmaceuticals News

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

Clarity Pharmaceuticals has successfully completed recruitment for its pivotal Co-PSMA Phase II trial, testing its novel Cu-SAR-bisPSMA diagnostic against the current standard in detecting prostate cancer recurrence. This milestone advances their mission to improve early detection and treatment outcomes for men with low PSA levels.

IDT Australia has signed a memorandum with NASDAQ-listed Gelteq to establish a dedicated gel-based product manufacturing facility, marking a strategic expansion in pharmaceutical delivery technologies.

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

BPH Global Ltd (ASX, BP8) has initiated strategic discussions with Indonesia’s National Economic Council to deploy its innovative seaweed-based bioremediation solutions targeting pollution from nickel and coal mining operations.

Biome Australia Limited has reported a 69% increase in international sales revenue for FY25, reaching $1.5 million, driven by new strategic distribution agreements across Ireland, New Zealand, and Canada.

Clever Culture Systems has sold its APAS Independence instrument to Novo Nordisk for a comprehensive evaluation across the pharmaceutical giant’s manufacturing network, marking a key step in its global sales strategy.

Nyrada has initiated the last cohort of its Phase I trial for Xolatryp, following a clean safety review of the highest dose tested so far. This step sets the stage for critical data that could shape the drug’s next development phase.

Hydralyte USA has completed its Rights Issue by placing 5 million shortfall shares, raising a total of $608,878 before costs. The move finalizes the company’s recent capital raising efforts under full regulatory compliance.

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.

Resonance Health is expanding its clinical trial operations with a third TrialsWest site in Mandurah, WA, set to open in August 2025, enhancing participant recruitment and supporting ongoing pharmaceutical trials.