Latest Therapeutics News

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Chimeric Therapeutics' CHM CORE-NK cell therapy achieved a 60% complete response rate in high-risk frontline AML patients, significantly exceeding typical outcomes and maintaining a strong safety profile.

Biome Australia has taken a significant step in its innovation journey by filing a patent for its next generation probiotic strain BMB18, with a clinical trial set to begin in Q4 FY26 in partnership with La Trobe University.

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.