Alpha Tau Medical Ltd. received FDA approval for an Investigational Device Exemption (IDE) supplement that expands its IMPACT pancreatic cancer study to include patients receiving gemcitabine with nab‑paclitaxel, in addition to the existing mFOLFIRINOX cohort. The supplement increases the total planned enrollment from 30 to 40 patients, allowing the company to gather more data on the safety and efficacy of its Alpha DaRT platform across two leading first‑line chemotherapy regimens.
The company also implanted Alpha DaRT sources in the first patient enrolled in its European ACAPELLA trial at CHU Grenoble Alpes in France. The procedure was performed under ultrasound‑guided endoscopic ultrasound and delivered in a single‑session approach that Alpha Tau claims preserves immune function and reduces toxicity compared with conventional therapies.
These milestones expand Alpha Tau’s global clinical evidence base. By running the IMPACT trial in the United States and the ACAPELLA trial in Europe simultaneously, the company positions itself to accelerate data readouts in the second half of 2026 and to demonstrate the platform’s feasibility across diverse patient populations and healthcare systems.
"Approval by the FDA to expand this important trial is wonderful news. The trial remains a key objective of ours as we seek to progress a new treatment for such a devastating cancer," said CEO Uzi Sofer.
"With the first ACAPELLA treatment, two multicenter trials – one in the US and now one across Europe – are now advancing simultaneously, marking a meaningful inflection point for Alpha DaRT in pancreatic cancer," added Chief Medical Officer Robert Den.
For the year ended December 31, 2025, Alpha Tau reported a net loss of $42.6 million, or $0.53 per share, compared with a net loss of $31.8 million, or $0.45 per share, in the prior year. The increase in loss reflects the company’s continued investment in clinical development and regulatory activities, typical for a clinical‑stage oncology company.
The company’s stock was trading around $8.08 on the day of the announcement, with a 52‑week high of $8.60. No immediate market reaction data were available beyond the current trading price.
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