The October 1 FDA meeting is the next major catalyst — a positive outcome aligning on Phase 3 design would significantly de-risk the program. The SNO26 late-breaking oral presentation in November provides additional near-term visibility. Traders should watch for any pre-announcement of FDA feedback before October 1.
Price Chart
Executive Summary
Radiopharm Theranostics announced positive interim Phase 2b data for RAD101, a PET imaging agent for recurrent brain metastases, showing 93% concordance with MRI (primary endpoint met) and 86% preliminary sensitivity. The data was selected for a late-breaking oral presentation at SNO26 (Nov 2026), and the company plans an FDA meeting on October 1, 2026 to align on a Phase 3 pivotal trial protocol. This is a significant clinical milestone for a pre-revenue biotech with a $28M market cap, addressing a ~$600M market with no approved PET products.
Key Facts
- RAD101 Phase 2b interim analysis met primary endpoint with 93% concordance between PET and MRI across all evaluable lesions
- Preliminary 86% sensitivity in 14 patients with six-month follow-up and/or biopsy data (secondary objective)
- Data selected for late-breaking oral presentation at SNO26 (Nov 12-15, 2026)
- FDA meeting planned for October 1, 2026 to align on Phase 3 pivotal trial protocol
- RAD101 has FDA Fast Track Designation for distinguishing recurrent brain metastases from treatment effect
- Brain metastases imaging has ~$600 million total addressable market with no currently approved PET products
- Partnership with Siemens Healthineers for manufacturing and distribution of 18F-labeled RAD101 for Phase 3 trial
Financial Impact
~$600M total addressable market for brain metastases imaging; no currently approved PET products; pre-revenue company with $28M market cap
Risk Factors
- Phase 3 trial may fail to replicate Phase 2b results
- FDA may require additional studies or data before approving pivotal trial design
- Company is pre-revenue with limited cash runway (clinical-stage biotech)
- Competing imaging modalities or emerging technologies could reduce market opportunity
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-099435 |
| Document: ea0305391-6k_radiopharm.htm | 0001213900-26-099435 |
| Document: 0001213900-26-099435-index-headers.html | 0001213900-26-099435 |
| Document: 0001213900-26-099435-index.html | 0001213900-26-099435 |
| Document: 0001213900-26-099435.txt | 0001213900-26-099435 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 6-K | — | awaiting T+5 | — | — |
Oct 20, 2026 6d ago | 6-K | $0.9900 | awaiting T+5 | — | $0.9600 (−3.03%) |
Oct 14, 2026 11d ago | SC 13G | $1.08 $0.9500 | ▼ −12.04% | ▼ −11.02% | $0.9600 (−11.11%) |
Oct 5, 2026 21d ago | 6-K | $1.27 $1.11 | ▼ −12.60% | ▼ −13.02% | $0.9600 (−24.41%) |
Oct 1, 2026 25d ago | 6-K | $1.48 $1.11 | ▼ −25.00% | ▼ −26.30% | $0.9600 (−35.14%) |
Sep 30, 2026 26d ago | 6-K | $1.62 $1.15 | ▼ −29.01% | ▼ −30.93% | $0.9600 (−40.74%) |
Sep 24, 2026 4w ago | EFFECT | $1.57 $1.48 | ▲ +5.85% | ▲ +5.43% | $0.9600 (+38.93%) |
Sep 22, 2026 4w ago | 6-K | $1.65 $1.52 | ▼ −7.88% | ▼ −6.69% | $0.9600 (−41.82%) |
Sep 14, 2026 6w ago | 6-K | $2.01 $1.61 | ▼ −19.90% | ▼ −20.01% | $0.9600 (−52.24%) |
Sep 11, 2026 6w ago | 6-K | $1.98 $1.65 | ▼ −16.67% | ▼ −16.45% | $0.9600 (−51.52%) |
US Market Status
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