Latest Biotechnology News

Alterity Therapeutics announces significant board changes, including the retirement of founding chairman Geoffrey Kempler and appointment of CEO Dr David Stamler as Managing Director, aligning leadership with its Phase 3 clinical ambitions.

Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.

Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.

Bio-Gene Technology Limited updates on its development of two novel insecticides, Flavocide and Qcide, highlighting regulatory progress, commercial partnerships, and a strong market outlook across multiple sectors.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Biotron Limited has launched a $1.5 million non-renounceable rights issue to fund its strategic acquisition of Sedarex Limited and support ongoing drug development programs. The capital raise follows shareholder approval and aims to diversify Biotron’s portfolio with a next-generation general anaesthetic.

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.

Paradigm Biopharmaceuticals has drawn down US$5 million under its convertible note facility to fund the accelerated expansion of its global Phase 3 trial for knee osteoarthritis treatment.

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.

Algorae Pharmaceuticals has announced a non-renounceable Loyalty Options Offer to eligible shareholders, aiming to raise up to $337,678 before costs, with potential additional capital of $4.7 million if all options are exercised. The capital raise supports the company’s pharmaceutical and AI research and development ambitions.