Latest Therapeutics News

Prescient Therapeutics has extended its Share Purchase Plan by three days after shareholders reported delays receiving application documents. The revised timetable places the offer’s results announcement just ahead of a planned briefing on the company’s PTX-100 development program.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Neurizon will redeem 1 million convertible notes held by Obsidian for US$1.15 million, while securing a two-month standstill on share sales. The biotechnology company says the transaction leaves it funded through the HEALEY ALS trial readout and completion.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

A multimillion-dollar, multiyear NIH grant will fund an expanded access program for Neurizon’s investigational NUZ-001, potentially giving up to 200 US patients access to the therapy for as long as 96 weeks. The program is designed to add long-term safety, survival and biomarker data alongside the pivotal HEALEY ALS trial.

Prescient Therapeutics has given shareholders another week to participate in its A$7 million share purchase plan, citing delayed documentation and requests for more time. The capital raising is intended to fund PTX-100 through a planned December 2026 Dose Optimisation Committee meeting.

Emyria has reported a sharp increase in FY26 revenue while expanding its psychedelic-assisted therapy network to five operational or announced clinics and 18 beds. Its first Sydney clinic is now fitted out and scheduled to begin treating patients in September, but utilisation and funding remain the next tests.

Neurizon has appointed Dr Chris Bremer as chief executive as its NUZ-001 ALS program moves towards topline Phase 2/3 results expected in late Q2 2027. The incoming CEO brings more than 20 years of pharmaceutical and biotechnology experience, including over US$1 billion in licensing transactions.

Arovella Therapeutics has released the first clinical batch of its off-the-shelf cell therapy ALA-101 and activated its inaugural trial site at The Alfred, setting the stage for patient dosing later this month.

Immuron Limited has inked an exclusive US distribution deal for PROIBS®, a European-certified medical device targeting abdominal discomfort, marking a key step in its digestive health portfolio growth.

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

Nexalis Therapeutics reports a 52% rise in half-year losses to $1.3 million amid funding facility cancellation and clinical trial suspensions, highlighting ongoing cash flow challenges.