Latest Biotechnology News

Memphasys has signed a three-year exclusive distribution agreement covering the Czech Republic, Slovakia and Kazakhstan, with minimum purchases worth approximately A$674,000. The deal expands Felix’s European footprint while adding dedicated commercial leadership in the region.

Patrys has formed an international Clinical Advisory Committee to help shape the next stages of RLS-2202, its injectable quetiapine candidate for delirium in acute-care settings. The appointments add recognised expertise in delirium research, intensive care and trial design, but do not yet provide clinical efficacy or regulatory evidence.

Cambium Bio has secured firm commitments for a conditional A$7.1 million placement, taking its proposed funding package to A$10.85 million for the pivotal Elate Ocular Phase 3 program. Completion depends on three inter-conditional shareholder resolutions at the company’s expected November AGM.

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.

Imagion Biosystems has signed nanoComposix to resume GMP-aligned manufacturing of the MagSense nanoparticle core, a move designed to support its FDA-cleared HER2 breast cancer programme without the fixed cost of an in-house facility. The agreement improves manufacturing readiness, but its value, duration and production commitments remain undisclosed.

Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.

Dimerix has secured Mexican composition of matter protection for its Phase 2-ready kidney drug DMX-652 until June 2041. The grant expands the asset’s patent estate ahead of planned clinical testing in acute kidney injury, although it brings no new clinical data or regulatory approval.

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.

Paradigm Biopharmaceuticals has drawn the remaining US$2 million available in Tranche 4 of its convertible note facility, adding approximately A$2.8 million to working capital. The funding comes as its fully enrolled Phase 3 knee osteoarthritis trial advances towards interim analysis and top-line results.

Immutep has narrowed eftilagimod alfa’s potential registration pathway to PD-L1-negative head and neck cancer and neoadjuvant soft tissue sarcoma after identifying product differences between manufacturing scales used in earlier studies and TACTI-004. A new 200 L manufacturing run is planned, but replacement trials are not targeted to start until the second half of 2027 and remain subject to regulatory, funding and partnering decisions.

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.

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.