Latest Therapeutics News

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.

CLINUVEL Pharmaceuticals secures Canadian marketing approval for SCENESSE®, expanding access to the only approved systemic photoprotective treatment for erythropoietic protoporphyria (EPP).

Patrys has assigned its deoxymab intellectual property to Yale University in a deal granting it half of all future commercialisation revenue, reducing capital needs while keeping long-term upside.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

Nexalis Therapeutics has ended funding negotiations with Point8 Capital after failing to secure a formal agreement, while successfully completing its IRX-616a Phase 1 trial with no serious adverse events. The company is reassessing clinical priorities amid funding uncertainty.

Starpharma has reached a key milestone in its collaboration with Radiopharm Theranostics, unlocking a $0.5 million option fee and advancing the partnership toward a potential $91 million licensing deal.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.

Neurotech International has received Notices of Allowance from the USPTO for two patents covering its lead drug NTI164, reinforcing its intellectual property position as it advances Phase 3 trials for autism spectrum disorder.

Imugene reports a second complete response in its Phase 1b trial of azer-cel combined with BTK inhibitors, including the first patient with Mantle Cell Lymphoma who had failed prior BTKi therapy.