Latest Therapeutics News

Alterity Therapeutics has secured FDA alignment on the chemistry and manufacturing controls for its ATH434 Phase 3 trial in Multiple System Atrophy, marking a pivotal regulatory milestone ahead of the planned mid-2026 End-of-Phase 2 meeting.

Noxopharm’s Sofra™ oligonucleotides, delivered via InhaTarget’s inhalable lipid nanoparticles, achieved a significant reduction in lung inflammation in preclinical models, broadening Sofra’s therapeutic reach and delivery versatility.

Invex Therapeutics reported promising preclinical findings on Exenatide’s effects in a human Alzheimer's disease model, alongside a steady cash position and reduced operating outflows in Q3 FY26.

Noxopharm signed a strategic MoU with Tezcat Biosciences, published major Sofra RNA research, and appointed Dr Olivier Laczka as CEO, while reporting positive safety data from its HERACLES trial and improving cash flow.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Racura Oncology has detailed how its lead drug candidate, (E,E)-bisantrene, silences the cancer-driving MYC gene by stabilising G-quadruplex DNA structures, providing critical preclinical validation ahead of ongoing clinical trials.

Alterity Therapeutics has unveiled fresh Phase 2 data revealing ATH434’s ability to slow functional decline in Multiple System Atrophy patients, measured by the novel MuSyCA scale. This reinforces the drug’s disease-modifying potential ahead of pivotal Phase 3 trials.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Invion Limited is broadening its non-melanoma skin cancer trial to include basal cell carcinoma patients following encouraging safety and efficacy data from squamous cell carcinoma cohorts, targeting the largest skin cancer segment.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

Nexalis Therapeutics has advanced its IRX-211 program by screening the first patient in a pivotal Phase 2 trial for Breakthrough Cancer Pain, aiming to address a significant unmet need in oncology supportive care.