MILAN, Nov. 12, 2025 (GLOBE NEWSWIRE) -- BetaGlue® Therapeutics (“BetaGlue” or the “Company”) a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose™ in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

“The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose™ and a meaningful step forward in our commitment to innovation in oncology,” said Alexis Peyroles, CEO of BetaGlue Therapeutics. “This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities.”

About BetaGlue Therapeutics

BetaGlue® Therapeutics is a clinical-stage oncology company developing a novel radiotherapy platform technology for the localised and targeted treatment of unresectable solid tumours called YntraDose® which is currently being evaluated for LA-PDAC and has further potential in other indications.

About YntraDose

YntraDose device is a locoregional therapy (LRT) intended for the percutaneous radio-ablation of unresectable solid tumors. It represents a novel technology that aim to deliver a targeted radiation dose using Yttrium-90 microspheres injected directly into the tumour site, within a glue matrix holding the Y-90 microspheres in place.

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Source: BetaGlue Therapeutics SpA