Alpha Tau Medical makes Alpha DaRT, small radioactive sources placed inside tumors to treat them with alpha radiation; it is approved in Japan for head and neck cancer but not in the U.S.
Alpha Tau's case rests on Alpha DaRT, an intratumoral radiation device approved in Japan for head and neck cancer. ReSTART enrolled 88 recurrent cutaneous squamous cell carcinoma patients; top-line data around the end of 2026 remain the central U.S. approval milestone, with the first modular PMA submission begun. IMPACT's early 2027 data and expanded REGAIN program provide additional opportunities. The Korean pancreatic MOU adds a potential trial requiring approvals. Management believes capital covers at least the next two years.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: ReSTART top-line data support a U.S. PMA
Do ReSTART's response results and durability support completing the U.S. PMA?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
ReSTART remains central as Alpha Tau explores a Korean pancreatic trial
Alpha DaRT's ReSTART pivotal readout will decide whether a Japan-approved, BTD-laden platform earns U.S. PMA or stalls on single-arm cSCC data
Alpha DaRT's ReSTART PMA readout will determine whether a novel brachytherapy platform earns its first U.S. regulatory foothold across a multi-indication strategy
Alpha DaRT's ReSTART pivotal readout will determine whether alpha-particle brachytherapy can secure U.S. PMA in recurrent cSCC and validate a multi-indication platform
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Gastrointestinal cancers, Other cancers
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
11 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.