Latest Therapeutics News

Tryptamine Therapeutics has enrolled its second patient in a pioneering clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with first dosing scheduled for December and results expected early next year.

Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Starpharma’s 2025 AGM highlighted breakthrough partnerships and clinical progress, positioning the biotech for growth. Key deals with Genentech and Radiopharm Theranostics underpin a promising pipeline and expanding revenue streams.

Biotron Limited’s lead HBV drug BIT-HBV001 demonstrates superior antiviral activity and synergy with the current standard treatment Tenofovir in preclinical models, advancing hopes for a more effective Hepatitis B therapy.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

Resonance Health has revealed ambitious growth plans at its 2025 AGM, projecting revenue to nearly quadruple by FY26 while maintaining positive EBITDA guidance. The company is broadening its global footprint and diversifying its clinical trial services across multiple therapeutic areas.

Chimeric Therapeutics reports promising interim results from its CHM CDH17 Phase 1/2 trial, with 75% disease control at 28 days and durable responses in gastrointestinal cancers.

Actinogen Medical’s XanaMIA Phase 2b/3 trial for Alzheimer’s disease has received a positive safety recommendation from its independent Data Monitoring Committee, allowing the study to proceed unchanged. Investors now await the critical efficacy analysis scheduled for January 2026.

Radiopharm Theranostics has successfully enrolled the second cohort in its Phase 1 trial of 177Lu-RAD204, with the Data Safety Monitoring Committee greenlighting a dose increase to 90mCi for the third cohort. Early results show promising tumor targeting and safety in multiple advanced cancers.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.