Alpha Tau's Eyes Set on Japan Approval: Alpha DaRT Heads Toward Year-End Regulatory Decision in Head & Neck Cancer Treatment

Alpha Tau Medical Ltd. (DRTS), a clinical-stage biopharmaceutical firm developing innovative approaches to solid tumor treatment, is approaching a critical juncture with regulatory authorities in Japan. The company has submitted marketing authorization requests to Japan’s PMDA for its lead candidate in recurrent head and neck cancer indications, with a decision anticipated around year-end 2025.

Regulatory Momentum Building

The submission represents a significant milestone for Alpha DaRT, the company’s proprietary platform designed to deliver localized alpha radiation directly to tumor sites. This mechanism allows the therapy to destroy malignant cells while preserving adjacent healthy tissue—a key advantage in treating challenging cancers where conventional approaches often cause collateral damage.

Multi-Front Clinical Development

Beyond the Japan regulatory pathway, Alpha Tau’s clinical pipeline spans multiple tumor types at varying developmental stages. The ReSTART trial, the company’s pivotal study, continues investigating Alpha DaRT in recurrent cutaneous squamous cell carcinoma (cSCC) across U.S. centers, with patient enrollment expected to conclude in the first quarter of 2026. This trial is positioned as foundational support for potential regulatory submissions.

In head and neck cancer specifically, the company is also conducting studies in Israel examining oral cavity squamous cell carcinoma and combination approaches pairing Alpha DaRT with pembrolizumab in locally advanced or metastatic disease.

Expanding Into High-Need Indications

The company is actively progressing into additional solid tumor categories where treatment options remain limited. A U.S. multi-center pilot study in pancreatic cancer is currently recruiting, with expected completion by Q1 2026. Given that the majority of pancreatic cancer patients present with unresectable disease, this study addresses a significant clinical unmet need.

Glioblastoma represents another focus area, with Alpha Tau targeting first-patient enrollment in its U.S. pilot before year-end 2025. Brain metastases investigations are concurrently underway in both Israel and U.S. locations. Earlier-stage feasibility assessments are also being conducted for liver metastases (Canada), lung cancer (Israel), prostate cancer (Israel), and vulvar cancer (U.K.).

Financial Position and Runway

For the first nine months of 2025, Alpha Tau reported a net loss of $30.5 million, compared to $23.6 million in the corresponding 2024 period. The increased burn rate reflects accelerated R&D and clinical trial spending. As of September 30, 2025, the company maintained $75.9 million in cash and equivalents, which management believes sufficient to fund operations through 2027.

The company has also highlighted progress in manufacturing readiness, including licensure of its New Hampshire facility, and ongoing collaborative discussions with Japan’s PMDA regarding potential approval pathways.

Market Performance

DRTS has traded between $2.20 and $4.69 over the past twelve months. Recent trading closed at $3.47, representing a 5.45% decline from the prior session.