Radiopharm Theranostics Announces Alignment with U.S. FDA - GlobeNewswire
GlobeNewswire · Nov 4, 12:00 PM
Radiopharm plans phase 3 trial for brain cancer imaging drug - Investing.com
Investing.com · Nov 2, 1:44 PM
Radiopharm Theranostics Reports Business Update - GlobeNewswire
GlobeNewswire · Nov 2, 1:00 PM
Market reactionShares rose 17% on Nov 6.
Radiopharm Theranostics is a clinical-stage company developing radiopharmaceuticals, led by RAD101, a PET imaging agent for detecting recurrent brain metastases; none are approved.
Radiopharm's case rests on RAD101 imaging for suspected recurrent brain metastases: Phase 2b met its primary endpoint with 93% MRI concordance across evaluable lesions. Pivotal preparation continues after the FDA meeting, with initiation now expected in 1Q27. Completed equity fundraising and a tax refund supplemented cash; the subsequent secured tax-incentive advance adds working capital. Continued spending leaves funding a workable pivotal study central. Early therapeutic programs and RAD301 imaging offer additional potential.
Thesis checklist
1 risk needs 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
Next decision point
Tests: FDA minutes confirm a workable Phase 3 for RAD101
Do the FDA minutes support a pivotal study Radiopharm can execute and finance?
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.
RAD101 start moves to 1Q27; pivotal funding remains central
RAD101 meets Phase 2b endpoint with 93% concordance, but a Q4 2026 cash cliff arrives before the FDA design meeting lands
RAD101 met its Phase 2b primary endpoint, but cash runs out in Q4 2026 before Phase 3 can deliver data
RAD101 Phase 2b interim data: 92% primary endpoint achievement
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
5 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.