- Trial Phase
- Phase 2b (completed, met primary endpoint); Phase 3 planned
- Time to Market
- Several years out — Phase 3 pivotal trial planned to start Q4 2026; no PDUFA date exists yet, so realistic US approval is likely 2028-2029 at the earliest if the pivotal study succeeds.
- Why 5/10
- The next hard, dated catalyst is the FDA End-of-Phase 2 meeting on October 1, 2026 to align on the RAD101 pivotal Phase 3 design, followed by a planned Phase 3 launch in Q4 2026 — a near-term regulatory milestone on the company's lead asset, but not a PDUFA/pivotal readout, so the score is capped at 5 per the no-dated-binary-in-12-months rule.
Watch the October 1, 2026 FDA End-of-Phase 2 meeting outcome (alignment on Phase 3 design) and the Q4 2026 Phase 3 launch announcement — both are the main near-term drivers for this ~$37M-market-cap, pre-revenue story. Beware continued dilution: the company just raised ~US$13M across tranches at a ~26% discount and burned ~$15M in one quarter, so a further capital raise before Phase 3 data is a real risk.
Price Chart
Executive Summary
RAD101 is Radiopharm Theranostics' lead asset: an F-18 PET imaging agent for diagnosing recurrent brain metastases in cancer patients after radiotherapy, where MRI is unreliable. A US Phase 2b trial met its primary endpoint with 93% concordance versus MRI, FDA granted Fast Track designation, and an End-of-Phase 2 meeting is scheduled for October 1, 2026 to align a global Phase 3 pivotal trial planned for Q4 2026. The company (Nasdaq: RADX, ADS of Australia's ASX-listed Radiopharm) is pre-revenue with a ~$37M market cap, recently raised ~US$13M at a ~26% discount amid ~$15M/quarter cash burn, and its ADS has fallen from a $16.25 52-week high to ~$2.39 — a high-risk, high-upside speculative setup where the stock's direction hinges on Phase 3 execution and continued financing, not near-term approval.
How It Works
RAD101 is a diagnostic imaging agent, not a treatment. It is a fluorine-18-labeled small molecule (18F-fluoropivalate) that binds to fatty acid synthase (FASN), an enzyme that is overproduced in many solid tumors including brain metastases. After a patient is injected, a PET scan lights up where the tracer collects, so doctors can tell whether a new-looking brain lesion after radiation is actual tumor regrowth or harmless radiation-related scar tissue — something standard MRI often cannot distinguish.
Trial Status
Phase 2b (NCT06777433), an open-label, single-arm US trial in ~30 patients with suspected recurrent brain metastases, met its primary endpoint of concordance with gadolinium MRI (final read 93% concordance; interim reads were ~90-92% across company releases). FDA granted Fast Track in June 2025, an End-of-Phase 2 meeting is set for October 1, 2026, and a global registrational Phase 3 imaging trial is slated to launch Q4 2026 with Siemens Healthineers supplying the F-18-labeled doses.
The Two-Sided Case
Upcoming Catalysts
- FDA End-of-Phase 2 meeting for RAD101 — October 1, 2026 (outcome on pivotal Phase 3 trial design)
- Planned launch of the global Phase 3 registrational imaging trial — Q4 2026
- Any additional financing announcements (the multi-tranche raise required shareholder approvals for later tranches)
- Quarterly 6-K reports and ASX operational updates on RAD101 enrollment
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Radiopharm Theranostics Ltd 6-K RADX ·Originating report