Radiopharm Theranostics Limited
RADX evidence brief
What we can confirm
- Market Cap:
- $29.1M
- Next Catalyst:
- Phase1_Start · Oct 30, 2026
What it means
What to watch
Prepared research question
What matters most for RADX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · RADX
Radiopharm Theranostics Limited (RADX) is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, with a focus on imaging and therapeutic programs targeting brain metastases and solid tumors.
Key risk: Pre-revenue stage
Tracking 7 clinical trials · 1 catalyst for Radiopharm Theranostics Limited.
Radiopharm Theranostics Limited (RADX) is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, with a focus on imaging and therapeutic programs targeting brain metastases and solid tumors.
- RAD101 Phase 2b imaging trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the primary endpoint [news · published 2026-09-14].
- Cash and cash equivalents of approximately $34.52 million as of January 2026 provide runway into 2027 [news · published 2026-01-28].
- End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1, 2026 to align on RAD101 Phase 3 pivotal trial protocol [news · published 2026-08-17].
- First patient dosed in second cohort of Phase 1/2a trial of BetaBart (RV-01) targeting B7-H3 expressing solid tumors [news · published 2026-08-26].
- Positive safety and favorable biodistribution reported from Phase 1 imaging trial of RAD301 in pancreatic ductal adenocarcinoma patients [news · published 2026-09-09].
What works
- RAD101 achieved 93% concordance with MRI in brain metastases imaging, a ~$600 million total addressable market with no currently approved PET products [news · published 2026-09-14].
- Multiple clinical programs advancing: RAD202 Phase 1 cleared to dose level of 180mCi, RAD204 dose escalation ongoing, and RV-01 first-in-human trial dosed [news · published 2026-08-20] [news · published 2026-08-26].
- Cash runway into 2027 with $34.52 million as of January 2026 supports pipeline through key clinical and regulatory milestones [news · published 2026-01-28].
- U.S. FDA granted Fast Track Designation for RAD101, indicating regulatory support for the program [news · published 2025-07-29].
What to weigh
- Company is pre-revenue and clinical-stage, with no approved products generating sales; financial sustainability depends on continued funding and trial success [news · published 2026-01-28].
- RAD101 Phase 3 pivotal trial design is not yet finalized; FDA meeting on October 1, 2026 is a critical regulatory gate [news · published 2026-08-17].
- Multiple programs (RAD202, RAD204, RV-01) are in early Phase 1/2a stages with limited data; safety and efficacy remain unproven at scale [news · published 2026-08-20] [news · published 2026-08-26].
- Brain metastases imaging market (~$600M) is addressable but competitive; no currently approved PET products suggests regulatory and adoption hurdles [news · published 2026-09-14].
From the filings
Quoted directly from source documents.
RAD101 Phase 2b trial met primary endpoint with 93% concordance with MRI
“RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint”
News · September 14, 2026
Cash position as of January 2026
“Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regu”
News · January 28, 2026
FDA meeting scheduled for October 1, 2026
“End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1st , 2026; on track to be Phase 3 ready by year-end 2026”
News · August 17, 2026
First patient dosed in second cohort of RV-01 trial
“today announced that it has dosed the first patient in the second cohort of its”
News · August 26, 2026
Catalyst timeline
- 2026-10-30 · Phase1_Start: A Phase 1, Multicenter Study of the Safety and Imaging of NTH-2403, a Lutetium-177 Radiolabeled Monoclonal Antibody Targeting the LRRC15 Epitope, in Participants With Locally Advanced or Metastatic Solid Tumors — Initiation of a new Phase 1 trial for NTH-2403, expanding the pipeline into LRRC15-targeted radiotherapeutics.
Risks & what to watch (4)›
Key risks
- Pre-revenue stage — No approved products or revenue; financial sustainability depends on continued funding and clinical success [news · published 2026-01-28].
- Regulatory dependency — RAD101 Phase 3 design pending FDA alignment on October 1, 2026; delay could impact timeline [news · published 2026-08-17].
- Early-stage pipeline — Most programs (RAD202, RAD204, RV-01) are in Phase 1/2a with limited data; high attrition risk [news · published 2026-08-20].
- Market adoption risk — Brain metastases imaging has no approved PET products; regulatory and commercial adoption path unproven [news · published 2026-09-14].
What to watch
- Outcome of FDA End-of-Phase 2 meeting on October 1, 2026 for RAD101 Phase 3 alignment [news · published 2026-08-17].
- Interim data from additional cohorts of RAD202 and RAD204 Phase 1 trials expected in mid-2026 [news · published 2026-01-28].
- Progress of RV-01 (BetaBart) Phase 1/2a trial in B7-H3 expressing solid tumors [news · published 2026-08-26].
- Cash burn rate and any new financing or partnership announcements given $34.52M runway into 2027 [news · published 2026-01-28].
Sources: Catalysts · News · Generated October 12, 2026 · How we verify sources →
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Evidence & data
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
7
Total value held
$2.1M
| Holder | Shares | Value |
|---|---|---|
| silverarc capital management, llc | 187,406 | $806K |
| stonepine capital management, llc | 51,000,000 | $739K |
| hsbc holdings plc | 61,372 | $265K |
| regal partners ltd | 40,138 | $173K |
| pnc financial services group, inc. | 16,000 | $69K |
| ubs group ag | 3,000 | $13K |
| rhumbline advisers | 121 | $519 |
Short Interest
as of May 22, 2026- % of float
- 0.6%
- Days to cover
- 1.0
- Shares short
- 35,793
- Daily short volume (Oct 12, 2026)
- 41.6%
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
RADX short interestFrequently asked questions
What is the AI investment thesis for Radiopharm Theranostics Limited?
Radiopharm Theranostics Limited (RADX) is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, with a focus on imaging and therapeutic programs targeting brain metastases and solid tumors.
What is Radiopharm Theranostics Limited's next catalyst?
Radiopharm Theranostics Limited's next tracked catalyst is a Phase1_Start event — "Phase1_Start: A Phase 1, Multicenter Study of the Safety and Imaging of NTH-2403, a Lutetium-177 Radiolabeled Monoclonal Antibody Targeting the LRRC15 Epitope, in Participants With Locally Advanced or Metastatic Solid Tumors" — expected October 30, 2026.
Who is the CEO of Radiopharm Theranostics Limited?
Mr. Riccardo Canevari is the chief executive officer of Radiopharm Theranostics Limited (RADX).
Where is Radiopharm Theranostics Limited headquartered?
Radiopharm Theranostics Limited (RADX) is headquartered in Carlton, VIC, Australia.
What therapeutic areas does Radiopharm Theranostics Limited focus on?
Radiopharm Theranostics Limited develops therapies across Oncology, Dermatology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.