Latest Clinical Data News

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.

PYC Therapeutics reports durable retinal gene expression and visual improvements from its PYC-001 candidate in Autosomal Dominant Optic Atrophy, supporting longer dosing intervals and expansion into glaucoma research.

Chimeric Therapeutics reports encouraging interim data from its Phase 1/2 trial of CHM CDH17 CAR-T therapy, with tumour shrinkage up to 40% and stable disease maintained for months at the highest dose level.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Biotron Limited has met the first milestone in its Sedarex acquisition by securing pivotal regulatory feedback from the European Medicines Agency, charting a clearer path for its next-generation anaesthetic SedRx.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Imugene has secured $11.12 million through a placement to advance its allogeneic CAR-T therapy azer-cel after early clinical data showed complete responses in BTKi-resistant lymphoma patients.

ReNerve Limited has secured regulatory approval to market its flagship NervAlign Nerve Cuff in Indonesia, marking a major step in its Asia-Pacific expansion and unlocking access to one of the region’s largest nerve repair markets.

Echo IQ has locked in a pivotal exclusive data licensing deal with Advara HeartCare, gaining access to as many as one million de-identified echocardiography studies, a move set to turbocharge its cardiovascular AI development.

OncoSil Medical secures a spot in the PALACROS consortium, advancing its OncoSil™ device through a cost-efficient Phase II trial targeting unresectable locally advanced pancreatic cancer.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.