Latest Pharmaceuticals News

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Osteopore Limited has secured an exclusive multi-year distribution agreement with Majeton to commercialise its dental and maxillofacial products in China, Hong Kong, and Macau, marking a major step in its Asia-Pacific expansion.

Clarity Pharmaceuticals confirms continuation of its SECuRE Phase II trial for Cu-SAR-bisPSMA without protocol changes, reporting encouraging safety and efficacy data in metastatic prostate cancer patients.

Recce Pharmaceuticals has received a $5.3 million R&D tax rebate from the Australian Taxation Office, providing a significant cash injection to support its innovative synthetic anti-infective drug development programs.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

Argent BioPharma has signed a binding agreement to acquire AusCann’s 48% stake in CannPal, enhancing its clinical and intellectual property assets for CannEpil®. The deal includes an option for the Neuvis® drug-delivery platform and aligns with Argent’s U.S. dual-listing ambitions.

Racura Oncology has launched a strategic collaboration with Emory University to investigate (E,E)-bisantrene’s potential to overcome resistance to osimertinib in EGFR-mutated non-small cell lung cancer. This partnership aims to bolster Racura’s HARNESS-1 clinical trial and strengthen its position in the competitive lung cancer treatment landscape.

Clinuvel Pharmaceuticals has initiated dosing in a preclinical study of its novel controlled-release injectable peptide platform, VLRX-L, aiming to enhance drug delivery for melanocortin-based therapies. Preliminary results are expected in the second half of 2026.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

BPH Global has refined its Project 6-7 R&D program to concentrate on recovering gold and silver from seaweed, aiming to fast-track commercialisation of this innovative bio-mining approach.

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.