Alpha Tau's Alpha DaRT Could Get Japan Green Light By Year-End—Here's What It Means

Alpha Tau Medical (DRTS) is quietly building one of the most ambitious cancer treatment platforms in biotech. Their Alpha DaRT technology sounds like sci-fi: inject tiny alpha-emitting particles directly into tumors to obliterate cancer cells while leaving healthy tissue untouched. Think of it as precision nuclear medicine at the cellular level.

The Regulatory Sprint

Here’s the catalyst: Japan’s PMDA is expected to greenlight Alpha DaRT for recurrent head and neck cancer by year-end 2025. This isn’t some distant maybe—it’s an anticipated milestone that could validate the entire platform. If Japan approves, other regulators will pay attention.

Meanwhile in the U.S., their pivotal ReSTART trial (testing the tech in recurrent cutaneous squamous cell carcinoma) should wrap recruitment by Q1 2026. This trial is literally the foundation for FDA submissions. Two regulatory pathways advancing simultaneously = de-risking the whole bet.

The Pipeline is Actually Stacked

Beyond head and neck, Alpha Tau is going after the hard cases:

• Glioblastoma: First patient enrollment expected before 2025 year-end in the U.S.
• Pancreatic cancer: Multi-center pilot running now, recruitment complete by Q1 2026. This one matters because most pancreatic patients are inoperable at diagnosis—Alpha DaRT could be a game-changer
• Brain metastases, liver metastases, lung cancer, prostate, vulvar cancer: All in various stages of exploration

They’re not just chasing sexy indications. They’re systematically mapping solid tumors where conventional surgery/chemo struggle.

The Financial Reality Check

9-month 2025 net loss: $30.5M (up from $23.6M YoY). Not surprising—R&D and clinical trials burn cash. Cash on hand: $75.9M, runway into 2027. They’ve licensed a New Hampshire manufacturing facility, meaning they’re serious about scaling production.

Stock’s been choppy: $2.20-$4.69 range over 12 months, currently $3.47. Classic biotech volatility—one regulatory win could swing it hard.

Why This Matters

Alpha DaRT is a rare example of novel mechanism + real clinical data + multiple shots on goal. Japan approval would be proof of concept. The pancreatic cancer angle is particularly intriguing because there’s massive unmet need. If they can show survival benefit in an inoperable population, this gets interesting fast.

Watch the PMDA decision closely. It’s the first domino.