Latest Therapeutics News

Memphasys Limited has secured Therapeutic Goods Administration approval for its Felix™ System two months ahead of schedule, enabling immediate commercial sales and clinical use in Australia.

Neuren Pharmaceuticals has dosed the first patient in its groundbreaking Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome, a rare genetic disorder with no approved therapies. The trial marks a significant step forward for the PMS community and rare disease drug development.

PYC Therapeutics has successfully closed a $537 million institutional placement and entitlement offer, positioning the company to raise at least $600 million to advance its RNA-based therapies targeting genetic diseases.

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Biome Australia has secured ethics approval to commence a pivotal human clinical trial of its proprietary probiotic strain BMB18, aiming to validate its benefits on digestive, sleep, and mood health.

PYC Therapeutics has launched a A$653 million capital raising to fund the clinical advancement of four RNA-based drug candidates targeting genetic diseases with significant unmet needs. The raise extends the company’s cash runway to 2030, supporting key clinical milestones and a transition to commercialisation.

PYC Therapeutics has launched a substantial $653 million equity raise to fund clinical trials for four promising drug candidates targeting genetic diseases. This capital injection aims to advance the company’s pipeline through critical human efficacy milestones.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

Argenica Therapeutics has won a crucial regulatory waiver from the European Medicines Agency, removing the need for paediatric trials for its stroke drug ARG-007 and clearing the way for faster adult market approval in Europe.

Recce Pharmaceuticals has secured a second Cooperative Research and Development Agreement with the U.S. Army Institute of Surgical Research to test its RECCE 327 Gel in burn wound infection models, underscoring growing military interest in its synthetic anti-infectives.

Invion Limited has secured a $2 million non-dilutive grant from the South Korean government to advance preclinical studies for oesophageal cancer, expanded its global Photosoft technology license, and raised $1.3 million via convertible notes to strengthen its financial position.