Latest Biopharmaceuticals News

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

NeuroScientific Biopharmaceuticals reports encouraging early clinical results for its StemSmart™ MSC therapy in preventing and treating kidney transplant rejection and injury.

McPherson’s Limited reported a 3.9% revenue decline to $139 million in FY25 amid a strategic shift to a pharmacy wholesaler model, posting a $15 million net loss but signaling moderate EBITDA growth ahead.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.

An independent in vivo study from the University of South Florida reveals ArtemiC™ significantly boosts survival and reduces inflammation in a severe viral model, reinforcing its promise as a novel immunomodulatory therapy.

CLINUVEL Pharmaceuticals is preparing to elevate its American Depository Receipt program to a Nasdaq Level II listing by the end of 2025, aiming to enhance visibility and trading access in the U.S. without altering its primary ASX listing.

Cogstate Ltd has reported a strong FY25 with 22% revenue growth and a near doubling of profit before tax, declaring its first fully franked dividend and preparing to launch its inaugural AI-powered product in FY26.

Telix Pharmaceuticals reported a robust 63% revenue increase in H1 2025, driven by commercial growth and strategic investments, while advancing key clinical trials and maintaining full-year guidance.

Argent BioPharma has signed a binding term sheet to acquire key assets from AusCann Group Holdings, significantly expanding its clinical pipeline, intellectual property, and European manufacturing and distribution capabilities ahead of a planned US stock exchange listing.

Telix Pharmaceuticals has recast its historical financials from AUD to USD to better reflect its US-centric revenue streams and reports increased operating expenditure tied to recent acquisitions and growth initiatives.

Race Oncology’s Phase 1b/2 trial of RC110 bisantrene for relapsed or refractory acute myeloid leukemia has demonstrated a 40% response rate, exceeding expectations and offering new hope for difficult-to-treat patients.

Argent BioPharma has achieved a significant milestone by commencing formal supply of its EU-GMP cannabinoid API for epilepsy treatment at a leading Slovenian hospital and gaining prescription approval for CannEpil™ in Germany, marking key steps in its European expansion.