Latest Biopharmaceuticals News

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

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.

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.

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.

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.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.

Zelira Therapeutics reports promising diabetic neuropathy study results with ZLT-L-007 surpassing Lyrica, while converting $3.25 million in notes to equity to bolster HOPE® 1 clinical development.