Latest Drug Development News

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

InhaleRx Limited has successfully closed its entitlement offer and placement, raising $857,730 to support the clinical development of inhaled treatments targeting cancer pain and mental health conditions.

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

Invion Limited’s partner Hanlim Pharm, backed by South Korea’s government grant, has secured up to A$2 million in non-dilutive funding to advance preclinical studies of HL270 for oesophageal cancer, paving the way for human trials in Australia.

INOVIQ Limited has reported compelling preclinical results for its CAR-NK-exosome therapy targeting triple-negative breast cancer, showing significant tumor reduction and perfect survival in treated mice.

Biotron Limited has closed its non-renounceable rights issue, raising $645,861 to advance its Hepatitis B virus drug development, with a shortfall commitment from Peak Asset Management still pending.

PYC Therapeutics reports positive safety outcomes from the initial phase of its clinical trial for PYC-003, a promising treatment for Polycystic Kidney Disease. The drug was well tolerated in healthy volunteers, paving the way for patient dosing and further trials.

Opthea Limited has announced a strategic pivot to develop OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women, aiming for ASX reinstatement in 2026. The company leverages strong intellectual property and cash reserves to pursue orphan drug designation and clinical development.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.