Latest Pharmaceuticals News

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Cogstate Ltd (ASX:CGS) has announced robust sales contract execution for the quarter ended 31 March 2026, with $25.4 million in new contracts and a growing revenue backlog supporting its clinical trial services business.

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.

Wellnex Life has extended its licensing and supply agreement with Haleon UK for soft gel liquid paracetamol products until March 2027, reinforcing its position in the global analgesics market.

Algorae Pharmaceuticals has reached a key regulatory milestone as the TGA accepts its initial registration dossier, paving the way for potential commercialisation of its generic medicines in Australia and New Zealand.

Pathkey.AI has secured a significant commercial contract with Imunexus Therapeutics, deploying its AI-driven TrialKey platform to enhance early-phase clinical trial design and capital raising efforts.

Emyria Limited has launched a targeted recruitment campaign in New South Wales to establish its fourth state-based clinical operation, aiming to tap into Australia's largest mental health market amid rising psychological injury claims.

Bioxyne Ltd has secured a manufacturing agreement with global cannabis giant Aurora Cannabis, marking a major step in its international expansion of pharmaceutical-grade medicinal cannabis products.

Firebrick Pharma has successfully secured $1.5 million through a strategic placement, positioning itself to accelerate business development and launch new products in key markets.

Botanix Pharmaceuticals has successfully renegotiated its API supply agreement, deferring significant purchases to later years and strengthening its financial position ahead of Sofdra's market rollout.