Expect near-term upside as the market digests the first-ever RECIST response in RAD204's Phase 1 and the regulatory-path-clearing Phase 2b for RAD101. Key catalysts to watch: RAD101 Phase 3 launch details and enrollment timeline in Q4 2026, and any additional RAD204 data from further dose escalation. Given the small market cap, even modest institutional accumulation could drive disproportionate moves.
Price Chart
Executive Summary
Radiopharm Theranostics announced positive clinical data from two programs: RAD204 Phase 1 achieved a confirmed partial response with one patient progression-free beyond 7 months, and RAD101 Phase 2b met its primary endpoint (93% concordance with MRI) with 86% sensitivity, supporting advancement to a Phase 3 pivotal trial in Q4 2026. For a $55M market cap biotech, these early-stage but compelling efficacy signals represent a material pipeline de-risking event.
Key Facts
- RAD204: First RECIST-confirmed partial response at dose level #3 (90 mCi); patient remained progression-free beyond 7 months.
- RAD204: No dose-limiting toxicities observed across all cohorts; generally well-tolerated.
- RAD101 Phase 2b: 93% concordance between PET and MRI across all evaluable lesions (primary endpoint met).
- RAD101: Preliminary sensitivity of 86% (12/14 patients) from six-month follow-up/biopsy data.
- RAD101: Company plans to initiate a U.S. Phase 3 pivotal trial in Q4 2026, with FDA Fast Track designation already granted.
- Brain metastases imaging addressable market estimated at ~$600M with no currently approved PET product.
Financial Impact
No financial figures disclosed; positive clinical data likely to increase valuation for this clinical-stage biotech; RAD101's $600M+ TAM represents significant revenue opportunity if approved.
Risk Factors
- RAD204 data from only two patients in the highest cohort; small sample size limits statistical robustness.
- RAD101 specificity data not yet available (expected Q4 2026); a poor specificity result could dampen enthusiasm.
- Clinical-stage biotech with no approved products or revenue; heavily dependent on successful Phase 3 outcomes and financing.
- Potential dilution risk given the $55M market cap and need for capital to fund Phase 3 trials.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-080180 |
| Document: ea029883601ex99-2.htm | 0001213900-26-080180 |
| Document: ea0298836-6k_radiopharm.htm | 0001213900-26-080180 |
| Document: 0001213900-26-080180-index-headers.html | 0001213900-26-080180 |
| Document: 0001213900-26-080180-index.html | 0001213900-26-080180 |
| Document: 0001213900-26-080180.txt | 0001213900-26-080180 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 6-K | — | awaiting T+5 | — | — |
Oct 20, 2026 6d ago | 6-K | $0.9900 | awaiting T+5 | — | $0.9960 (+0.61%) |
Oct 14, 2026 11d ago | SC 13G | $1.08 $0.9500 | ▼ −12.04% | ▼ −11.02% | $0.9960 (−7.78%) |
Oct 5, 2026 21d ago | 6-K | $1.27 $1.11 | ▼ −12.60% | ▼ −13.02% | $0.9960 (−21.57%) |
Oct 1, 2026 25d ago | 6-K | $1.48 $1.11 | ▼ −25.00% | ▼ −26.30% | $0.9960 (−32.70%) |
Sep 30, 2026 26d ago | 6-K | $1.62 $1.15 | ▼ −29.01% | ▼ −30.93% | $0.9960 (−38.52%) |
Sep 24, 2026 4w ago | EFFECT | $1.57 $1.48 | ▲ +5.85% | ▲ +5.43% | $0.9960 (+36.64%) |
Sep 22, 2026 4w ago | 6-K | $1.65 $1.52 | ▼ −7.88% | ▼ −6.69% | $0.9960 (−39.64%) |
Sep 14, 2026 6w ago | 6-K | $2.01 $1.61 | ▼ −19.90% | ▼ −20.01% | $0.9960 (−50.45%) |
Sep 11, 2026 6w ago | 6-K | $1.98 $1.65 | ▼ −16.67% | ▼ −16.45% | $0.9960 (−49.70%) |
US Market Status
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