Latest Drug Development News

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

TrivarX has made Stabl-Im its central development bet, but the ASX-listed health technology company also reported an $8.76 million FY2026 loss and an auditor-flagged material uncertainty over its ability to continue without further funding. The planned Phase 1 study remains subject to regulatory, ethics and operational clearances.

Argent BioPharma has secured exclusive commercialisation rights to selected Tollovir, Tollovid and NutraVir antiviral products in a worldwide deal excluding China. The agreement adds a new commercial pillar alongside CimetrA®, but does not itself grant pharmaceutical development rights or establish clinical efficacy.

Telix will acquire ITM in a proposed US$1.65 billion deal that combines a commercial radioisotope supplier with Telix’s precision medicine and therapeutic pipeline. The transaction could give Telix greater supply-chain control and entry into a validated cancer treatment market, but it also brings dilution, integration risk and an unresolved FDA pathway for ITM-11.

Vectus Biosystems swung to a $1.56 million FY2026 profit, but the result was driven largely by the sale of its VB4-P5 compound for XORTX shares and warrants rather than recurring operations. The company is now directing its resources towards VB0004 while its auditor flags material uncertainty over ongoing funding.

Emyria has presented its regulated Australian psychedelic-treatment experience to the US FDA, putting clinical delivery systems rather than drug development at the centre of its US ambitions. The appearance raises the company’s profile, but does not yet disclose regulatory approval, a commercial agreement or a financial commitment.

Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.

Emyria has reported a sharp increase in FY26 revenue while expanding its psychedelic-assisted therapy network to five operational or announced clinics and 18 beds. Its first Sydney clinic is now fitted out and scheduled to begin treating patients in September, but utilisation and funding remain the next tests.

Nexalis Therapeutics reports a 52% rise in half-year losses to $1.3 million amid funding facility cancellation and clinical trial suspensions, highlighting ongoing cash flow challenges.

Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.

BLS Pharmaceuticals (ASX: BLS) reported a standout FY26 with revenue surging 161% to $74.2 million and net profit more than tripling to $15.4 million, driven by expanded manufacturing and major international contracts including a $50 million German supply deal.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.