Latest Biologicals News

Algorae Pharmaceuticals strengthened its balance sheet with $5.47 million cash reserves and broadened its commercial footprint through new licensing deals and AI-driven drug validation.

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

European Metals Holdings has secured critical regulatory milestones for its Cinovec Lithium Project, submitting the full Environmental Impact Assessment and obtaining Regional Rezoning approval. The company also raised A$3.46 million to support ongoing development.

Cambium Bio has clinched FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development complexity, while bolstering its cash position through a A$2.4 million strategic placement by major shareholder ZYBT.

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

Immutep Limited has won FDA Orphan Drug Designation for its immunotherapy eftilagimod alfa in treating soft tissue sarcoma, opening regulatory incentives and potential market exclusivity. This follows encouraging Phase II data despite recent Phase III trial setbacks.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Algorae Pharmaceuticals has launched a second collaboration with Peter MacCallum Cancer Centre to validate AI-predicted drug combinations across multiple cancer types, aiming to accelerate its drug development pipeline.

Atlas Pearls Ltd has disclosed a significant 27% revenue decline and a net loss for the half year ended December 2025, attributing the results to weaker auction outcomes and one-off accounting impacts. The company affirms timely disclosure and compliance with ASX rules amid market sensitivity.