Latest Drug Development News

Cogstate Ltd (ASX:CGS) posted a 15.9% rise in profit before tax to US$16.1 million for FY26, driven by a 116% surge in clinical trial sales contracts to $89 million and a 15% revenue increase. The company doubled its final dividend to A$0.04 per share, supported by a strong $118.5 million contracted revenue backlog.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

Amplia Therapeutics reported encouraging mature data from its ACCENT trial, initiated a Phase 2b pancreatic cancer study, launched an ovarian cancer trial, and refreshed its board leadership while maintaining a solid cash balance of A$24 million.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

Prescient Therapeutics boosted enrolment in its PTX-100 Phase 2a trial to 28 patients and appointed Dr Rosalind Wilson as Chief Medical Officer, strengthening its clinical leadership as it advances targeted cancer therapies.

Syntara secured positive FDA feedback for its Phase 2b amsulostat trial in myelofibrosis and raised $8 million to extend its cash runway to Q3 2027, while preliminary data showed promising brain inflammation reduction in a Parkinson’s-related disorder.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

Dimerix has strengthened its kidney disease pipeline with a US patent grant for DMX-652, extending protection until 2043 and setting the stage for a Phase 2 trial targeting acute kidney injury after cardiac surgery.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its Phase 1b trial of PYC-003 for Polycystic Kidney Disease, alongside regulatory clearance for an Open-Label Extension allowing continuous dosing up to 24 months.