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Radiopharm Theranostics Limited American Depositary Shares

RADXFDA catalysts, PDUFA dates & pipeline intelligence
$1.02
▼ -0.06 · -5.56%

Financials

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52W LOW $0.9052W HIGH $16.25
Volume
22.24 K
Value Traded
29.46 K
Short % Float
-
Days to Cover
2.4
+2.41%Week
-19.69%1 Month
-67.2%3 Month
-77.33%6 Month

Cash Data

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  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
14.88 M
EPS (TTM)
-2.94
P/E Ratio
-
Ent. Value
30.80 M
Total Shares
14.59 M
Float Shares
-
Insiders
-
Institutions
1.81%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 2b data presentation
18F-RAD101
recurrent brain metastases from solid tumors
Fast Track
Phase 2bRadiopharmaceuticalsNervous System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

RADX Catalyst Timeline

Dated clinical, regulatory and corporate events for Radiopharm Theranostics Limited American Depositary Shares

Catalyst Timeline

Dated clinical, regulatory & corporate events for Radiopharm Theranostics Limited American Depositary Shares

243Total events
27Upcoming
62Tier-1 (high impact)
2024 to 2026Coverage

Upcoming catalysts 2

T2Trial Initiation
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RAD101
T3Additional Data
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RAD101

Event history 50

▲End Of Phase 2 MeetingRAD101FDA Meeting
Radiopharm completes End-of-Phase 2 meeting with FDA for RAD101
brain metastases imagingsource ↗
▲Interim AnalysisRAD101Trial
Positive interim analysis data from Phase 2b imaging trial of RAD101
suspected recurrent brain metastases from solid tumorssource ↗
▲Primary Endpoint MetRAD101Clinical Data
RAD101 PET demonstrated 93% concordance with MRI, meeting primary endpoint
suspected recurrent brain metastases from solid tumorssource ↗
▲Topline ReadoutRAD301Clinical Data
Positive Phase 1 imaging trial data for RAD301 in PDAC
Pancreatic Ductal Adenocarcinoma (PDAC)source ↗
▲Safety Data UpdateRAD301Clinical Data
Favorable safety profile in all evaluable Phase 1 participants
Pancreatic Ductal Adenocarcinoma (PDAC)source ↗
▲Biomarker DataRAD301Clinical Data
Significant and selective tumor uptake in pancreatic cancer metastases
Pancreatic Ductal Adenocarcinoma (PDAC)source ↗
▲First Patient DosedRV-01Trial
First patient dosed in second cohort of Phase 1/2a trial of RV-01
B7-H3 expressing solid tumorssource ↗
▲DSMB ReviewRV-01Trial
SMC recommends advancement to 70 mCi dose of RV-01
B7-H3 expressing solid tumorssource ↗
▲DSMB ReviewRAD202Trial
DSMC positive recommendation to advance to Cohort 4 (180mCi)
HER2-positive advanced solid tumorssource ↗
▲Enrollment MilestoneRAD202Trial
Advance to Cohort 4 (180mCi)
HER2-positive advanced solid tumorssource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How RADX actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2025-12-31177Lu-RAD202 (RAD202) Phase 1 data readout Phase 1
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

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Every scored asset with PTRS, rNPV, enrollment velocity and trial design quality.
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Clinical Trial Results

Readouts, endpoints and source filings for every RADX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
RAD101
Fast Track
suspected recurrent brain metastases from solid tumorsPhase 2b2026-09-1493%; 86%Read MoreRadiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual MeetingRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
SILVERARC CAPITAL MANAGEMENT, LLC 0.1 % 805.85 K 187.41 K
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Shares held by hedge funds each quarter, and who bought or sold.

Ownership Trends

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Insider and institutional ownership, quarter by quarter.

RADX Short Interest

Shares sold short, counted twice a month.

-
Short % of Float
of tradable shares sold short
141.9K
Shares Sold Short
+313.3% vs prior count
2.4 Moderate
Days to Cover
trading days of normal volume to buy every short share back
60.2K
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

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Call OI
Put OI
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OI 30-day avg
Today vs avg
Option Volume
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Put-Call Ratio
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Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How RADX ranks across every disease it competes in

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See how RADX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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RADX News

-RADX
Nov 2, 2026
RADXGeneral
▼ -5.6%today

Radiopharm Theranostics Reports Business Update

Radiopharm Theranostics reported a successful End-of-Phase 2 meeting with the FDA for RAD101, clearing the path for a Phase 3 trial in brain metastases. The company also announced positive Phase 1 imaging data for RAD301 in pancreatic cancer and advanced RAD202 to its fourth dosing cohort. Cash reserves rose to $7.5 million following a $12.5 million institutional placement and an R&D tax refund.

Read more →
-RADX
Oct 5, 2026
RADXPhases
▼ -10.6%on this news· ran to -22% by day 3

Radiopharm Completes Productive End-of-Phase 2 Meeting with U.S. Food and Drug Administration for Pivotal Development Program of RAD101

Radiopharm Theranostics has successfully completed an End-of-Phase 2 meeting with the FDA for RAD101, a radiopharmaceutical imaging agent targeting brain metastases. The meeting provided constructive feedback, enabling the company to advance its pivotal clinical development plan. RAD101 has shown a 93% concordance with MRI in prior trials, and the company is now preparing for Phase 3 activities while awaiting official FDA feedback.

Read more →
-RADX
Sep 14, 2026
RADXPhases

Radiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual Meeting

Radiopharm Theranostics announced positive interim data from its Phase 2b trial of RAD101, which showed 93% concordance with MRI in detecting brain metastases. This data will be presented at the Society of Neuro-Oncology Annual Meeting. The company plans to discuss the Phase 3 trial protocol with the FDA on October 1.

Read more →
-RADX
Sep 9, 2026
RADXPhases

Radiopharm Theranostics Announces Positive Data from the Phase 1 Imaging Trial of RAD301 in Patients with Pancreatic Ductal Adenocarcinoma

Radiopharm Theranostics announced positive results from its Phase 1 imaging trial of RAD301 in patients with pancreatic ductal adenocarcinoma. The trial demonstrated significant tumor uptake and a favorable safety profile, supporting the potential of RAD301 as a diagnostic and therapeutic tool. The findings indicate a promising future for RAD301 in improving detection and treatment options for pancreatic cancer.

Read more →
-RADX
Aug 26, 2026
RADXPhases
▼ -6.5%on this news

Radiopharm Theranostics Doses First Patient in Second Cohort of Phase 1/2a Clinical Trial of BetaBart (RV-01) in B7-H3 Expressing Solid Tumors

Radiopharm Theranostics has successfully dosed the first patient in the second cohort of its Phase 1/2a clinical trial for RV-01, a radiopharmaceutical targeting B7-H3 expressing tumors. The trial follows a positive recommendation from the Safety and Monitoring Committee to escalate the dose. RV-01 has demonstrated promising preclinical results, indicating potential efficacy in oncology.

Read more →
-RADX
Aug 20, 2026
RADXPhases
▼ -8.4%on this news

Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee to Advance to Cohort 4 in 177Lu-RAD202 Phase 1 HEAT Clinical Trial

Radiopharm Theranostics has received a positive recommendation from the Data Safety and Monitoring Committee to advance its 177Lu-RAD202 Phase 1 HEAT clinical trial to the next dose level of 180mCi. This decision follows a previous study that demonstrated clinical proof-of-concept and positive safety results in HER2-positive advanced solid tumor patients. The trial is currently ongoing at various clinical centers in Australia.

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-RADX
Aug 17, 2026
RADXPhases

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

Radiopharm Theranostics has scheduled an End-of-Phase 2 meeting with the U.S. FDA for October 1, 2026, to discuss the pivotal Phase 3 trial design for RAD101, aimed at diagnosing brain metastases. The Phase 2b trial showed a 93% concordance with MRI, indicating strong potential for RAD101 in clinical settings. The company is on track for Phase 3 readiness by the end of 2026.

Read more →
-RADX
Jul 24, 2026
RADXGeneral
▼ -17.2%on this newsshared move

Radiopharm Theranostics Announces Concurrent US$4.1 Million Registered Direct Offering and Up To Additional A$12.7 (US$8.9) Million Australian Placement and Share Purchase Plan

Radiopharm Theranostics has announced a US$4.1 million registered direct offering of American Depositary Shares (ADSs) and a concurrent Australian placement potentially raising an additional US$8.9 million. The funds will be utilized for the RAD101 registrational study and other clinical programs. The offerings are subject to shareholder approval and customary closing conditions.

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-RADX
Jul 22, 2026
RADXPhases
▼ -17.2%on this newsshared move

Radiopharm Theranostics Achieves Confirmed Durable Partial Response in Ongoing Phase 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-Immunotherapy

Radiopharm Theranostics announced positive results from the Phase 1 trial of RAD204, a PD-L1-targeted radiotherapeutic for advanced solid tumors. The first patient achieved a durable RECIST-confirmed Partial Response, remaining progression-free for over seven months. The second patient also shows early signs of tumor shrinkage. RAD204 has been well-tolerated with no significant toxicities reported.

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-RADX
Jul 22, 2026
RADXPhases
▼ -17.2%on this newsshared move

Radiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain Metastases

Radiopharm Theranostics announced positive results from its Phase 2b trial of RAD101, achieving a 93% concordance with MRI for diagnosing brain metastases. The trial demonstrated an 86% sensitivity in 14 patients, supporting the advancement to a Phase 3 trial planned for Q4 2026. The company aims to address a significant market need for effective imaging in neuro-oncology.

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-RADX
Jun 3, 2026
RADXGeneral

Appendix 3H - Notification of cessation of securities Announcement Summary Entity name RADIOPHARM THERANOSTICS LIMITED Announcement Type New announcement Date of this announcement Wednesday

Radiopharm Theranostics Limited announced the cessation of certain securities, specifically 505,598 options expiring on various dates. This cessation is attributed to the expiry of options or other convertible securities that were not exercised or converted. The announcement details the company’s issued capital following this cessation, with substantial asset holdings in other options and ordinary shares. The entity did not provide any consideration for the cessation of the securities.

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-RADX
May 1, 2026
RADXGeneral

Services and Company Secretary Changes

Radiopharm Theranostics announced changes in its financial services and company secretary roles. Mr. Phillip Hains has resigned as Chief Financial Officer and Joint Company Secretary, with the Board expressing gratitude for his contributions. Mr. Aaron Laurita has been appointed to assume the CFO role, while Ms. Amritha Sushil will serve as Joint Company Secretary, enhancing the company's governance structure. These changes reflect Radiopharm's commitment to maintaining effective leadership in their operations.

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-RADX
Apr 23, 2026
RADXPhases

Radiopharm Theranostics Reports Business Update Completed enrolment in Phase 2b clinical trial

Radiopharm Theranostics has completed enrollment in a Phase 2b trial for RAD 101, achieving a promising 90% concordance with MRI in patients with recurrent brain metastases. The company also presented encouraging data for RAD 202, which indicated good tumor uptake and a favorable safety profile. Furthermore, the Data and Safety Monitoring Committee has recommended advancing RAD 202 to higher dosing levels, highlighting its potential for effective cancer treatment. Radiopharm is enhancing its pipeline with two new First-In-Human clinical trials for additional radiotherapeutics.

Read more →
-RADX
Apr 20, 2026
RADXPhases

Radiopharm Theranostics Presents Initial Findings from Phase 1 First-in-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026

Radiopharm Theranostics presented initial findings from its Phase 1 HEAT clinical trial for 177Lu-RAD202 at the AACR Annual Meeting 2026. The trial demonstrated promising tumor uptake and a favorable safety profile in patients with HER2-positive solid tumors. The Data Safety and Monitoring Committee has approved advancing to a higher dose, indicating potential for further therapeutic evaluation.

Read more →
-RADX
Apr 16, 2026
RADXPhases

Radiopharm Theranostics Completes Enrollment in U.S. Phase 2b Imaging Trial of RAD 101 for Diagnosis of Brain Metastases

Radiopharm Theranostics has completed the enrollment of the final patient in its U.S. Phase 2b imaging trial for RAD 101, which targets brain metastases. Interim results indicate a 90% concordance with MRI, which positions the product favorably in detecting recurrent brain metastases. The CEO expressed optimism about the upcoming clinical trial readout scheduled for June 2026 and plans to initiate the next Phase 3 trial. The company received FDA Fast Track Designation for RAD 101, which highlights its significance in addressing a crucial unmet medical need in oncology.

Read more →
-RADX
Apr 8, 2026
RADXPhases

Radiopharm Theranostics advances to Cohort 3 in 177Lu-RAD202 Phase 1 Dose Escalating Clinical Trial

Radiopharm Theranostics has progressed to Cohort 3 in its Phase 1 HEAT' clinical trial for 177Lu-RAD202, a treatment targeting HER2-positive advanced solid tumors. Following a positive recommendation from the Data Safety and Monitoring Committee, the company plans to escalate the dose level to 130mCi. The trial is currently ongoing at various clinical centers across Australia, with an objective to complete the dose escalation by the end of 2026. CEO Riccardo Canevari expressed optimism regarding the trial's favorable safety profile and rapid progress.

Read more →
-RADX
Apr 7, 2026
RADXPhases

Radiopharm Theranostics and Siemens Healthineers Sign Clinical Supply Agreement for RAD101 in the U.S.

Radiopharm Theranostics has entered into a Clinical Supply Agreement with Siemens Healthineers for RAD101, a novel imaging agent for diagnosing recurrent brain metastases. Interim analysis from the Phase 2b trial revealed significant tumor uptake and a 90% concordance rate with MRI. The partnership is crucial for scaling up production for a forthcoming Phase 3 trial. Additionally, RAD101 has received FDA Fast Track Designation, indicating its potential importance in U.S. clinical settings.

Read more →
-RADX
Mar 27, 2026
RADXPhases

Radiopharm Theranostics Doses First Patient in Phase 1 Clinical Study of RAD 402 in Advanced Prostate Cancer On track to share data from first two dose levels

Radiopharm Theranostics announced the dosing of the first patient in its Phase 1 clinical trial of RAD 402, aimed at treating advanced prostate cancer. The trial will assess the drug's safety, tolerability, and preliminary clinical activity. RAD 402 is a monoclonal antibody targeting KLK3, with promising preclinical results indicating effective tumor targeting and minimal off-target exposure. The company plans to share data from the first two dose levels in the second half of 2026.

Read more →
-RADX
Mar 24, 2026
RADXPhases
▼ -10.8%on this newsshared move

Radiopharm Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases

Radiopharm Theranostics announced positive results from the second interim analysis of its Phase 2b clinical trial of RAD 101 in patients with brain metastases. The trial showed that 90% of the 20 evaluated patients achieved concordance with MRI imaging, meeting the primary endpoint. Additionally, the early data from five patients indicated an encouraging trend in sensitivity and specificity for the imaging agent. The company looks forward to final results from the full study, which will guide future trials.

Read more →

About Radiopharm Theranostics Limited American Depositary Shares

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