$RADX

Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) completed an End-of-Phase 2 meeting with the FDA for RAD101, its investigational imaging agent for brain metastases. The FDA provided a clear framework for the pivotal development plan. The company is preparing for Phase 3 trials and expects to receive official meeting minutes within 30 days. RAD101 has shown 93% concordance with MRI in Phase 2b trials and has received FDA Fast Track Designation.

Radiopharm Theranostics (RADX) announced positive interim data from its Phase 2b trial of RAD101, a PET imaging agent for brain metastases, was selected for a late-breaking presentation at the SNO26 meeting. The data showed 93% concordance with MRI and 86% sensitivity. RAD101 has FDA Fast Track designation. The company plans a Phase 3 trial and expects to meet with the FDA in October 2026. RADX stock is up 0.17% at $1.98.

Radiopharm Theranostics (RADX) reported positive Phase 1 imaging trial results for RAD301 in pancreatic cancer patients, showing favorable safety, selective tumor uptake, and potential for improved disease detection. The company plans to advance to Phase 2 development. RADX stock closed at $2.12, up 1.92%, and is trading at $2.20 in pre-market.

Radiopharm Theranostics (RADX) announced its Phase 1 HEAT trial for 177Lu-RAD202 will advance to Cohort 4 at a higher 180mCi dose level, per the Data Safety and Monitoring Committee's recommendation. The trial, evaluating RAD202 for HER2-positive advanced solid tumors, previously used a 130mCi dose. RADX stock closed at $2.50, up 1.20% in pre-market trading.

Radiopharm Theranostics (RADX) said it will hold an End-of-Phase 2 meeting with the FDA on Oct. 1, 2026 to align on pivotal Phase 3 trial design for RAD101 in suspected recurrent brain metastases after radiotherapy. The company cited Phase 2b results showing 93% MRI concordance and selective tumor uptake. RAD101 has Fast Track status and Siemens will manufacture and distribute it for a planned Phase 3 starting Q4 2026.

Radiopharm Theranostics (NASDAQ: RADX) entered a securities purchase agreement for a registered direct offering of 1,281,646 ADSs (384,493,800 ordinary shares) at $3.16 per ADS, raising about $4.1 million gross. Investors also receive unregistered warrants for up to 1,281,646 ADSs, exercisable after shareholder approval at $3.79 per ADS, expiring July 31, 2029. Closing expected around July 28, 2026.

Radiopharm Theranostics (NASDAQ: RADX) shares fell about 21% after the company announced a $13 million capital raise via concurrent U.S. and Australian offerings. It will issue 1,281,646 ADS at $3.16 in a registered direct offering, raising about $4.1 million gross. It also plans warrants at $3.79 per ADS, expiring July 31, 2029, subject to shareholder approval.

Radiopharm Theranostics (RADX) reported positive clinical updates. In a Phase 2b trial, RAD101 met its primary endpoint, showing 86% accuracy for detecting brain metastases across tumor types, with specificity due in Q4 2026. In a Phase 1 trial, RAD204 showed a RECIST-confirmed durable partial response at 90 mCi, with no dose-limiting toxicities. RADX stock last $4.29.

DSMC concluded that Phase 1 study may continue as planned without any modifications On track to complete the enrollment of the first two cohorts by mid-2025