Latest Biopharmaceuticals News

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

Immuron Limited has launched PROIBS®, a new medical device aimed at relieving symptoms of Irritable Bowel Syndrome (IBS), entering a growing Australian market with strong early demand.

Telix Pharmaceuticals reports a robust 53% revenue jump in Q3 2025 and raises its full-year guidance, underpinned by key reimbursement wins and expanding clinical programs.

Immuron Limited reports a robust 34% year-on-year sales increase for Q1 FY26, driven by strong growth in Australia and the USA, while Canadian sales dip seasonally. The company’s marketing efforts and expanding retail presence underpin this momentum.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Opthea Limited has received a substantial A$10.8 million R&D tax incentive from the Australian government, reinforcing its commitment to advancing its novel drug candidate sozinibercept. This funding milestone underscores the company’s strategic focus on innovation and fiscal discipline.

Invex Therapeutics has ended negotiations on two neurological asset acquisitions following due diligence setbacks and shareholder disputes, while advancing R&D collaborations and managing financial stability.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

Race Oncology has uncovered that its anticancer drug bisantrene exists as three light-sensitive isomers, with only one showing potent activity. The company has filed patents to protect this active form, potentially extending its intellectual property rights until 2045.