Latest Drug Development News

Paradigm Biopharmaceuticals has strengthened its balance sheet with a combined $5.75 million cash inflow from Australian Government R&D tax incentives, supporting its pivotal Phase 3 osteoarthritis trial and regulatory efforts.

Biotron has received pivotal regulatory feedback from the European Medicines Agency ruling out a Hybrid Marketing Authorisation for SedRx, prompting plans for pivotal clinical trials. The company also advances its lead antiviral candidate BIT-HBV001 against Hepatitis Delta Virus and appoints a new chairman.

Dimerix has acquired DMX-652, a Phase 2-ready oral drug candidate targeting acute kidney injury, expanding its renal disease portfolio. The acquisition includes patent rights, an FDA-approved trial protocol, and funding to initiate clinical development.

TrivarX has locked in investigational product supply critical for starting its Phase 1 clinical trial of the Stabl-Im MRI imaging platform, targeting a 2026 trial commencement.

Nexalis Therapeutics has issued share rights to directors in lieu of fees, with vesting contingent on successful Phase 2 clinical trial completion, aiming to conserve cash for ongoing drug development.

Recce Pharmaceuticals has expanded its intellectual property footprint with a key patent granted in Vietnam for its RECCE® anti-infective drugs, reinforcing its presence in a critical Southeast Asian market grappling with high antibiotic resistance.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Immutep’s INSIGHT-003 trial shows promising overall survival in first-line non-squamous NSCLC, yet the Phase III TACTI-004 trial was discontinued following a futility analysis. Ongoing root cause investigations aim to clarify the divergent outcomes.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Starpharma has reached a key milestone in its collaboration with Radiopharm Theranostics, unlocking a $0.5 million option fee and advancing the partnership toward a potential $91 million licensing deal.

Neuren’s partner Acadia secures positive CHMP opinion for DAYBU® in Rett syndrome, paving the way for first EU treatment approval and triggering significant milestone payments for Neuren.

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.