Welcome to our dedicated page for Radiopharm Theranostics news (Ticker: RADX), a resource for investors and traders seeking the latest updates and insights on Radiopharm Theranostics stock.
Radiopharm Theranostics Limited (NASDAQ: RADX, ASX: RAD) generates frequent news flow as a clinical-stage radiotherapeutics company developing radiopharmaceutical diagnostics and therapies for solid tumor cancers. Its announcements cover progress across a pipeline that includes peptides, small molecules and monoclonal antibodies radiolabelled with medical isotopes for oncology applications.
Readers of this page can follow updates on key clinical programs such as 18F‑RAD101, a FASN‑targeting imaging agent in a U.S. Phase 2b trial for suspected or recurrent brain metastases, which has received FDA Fast Track Designation. News also highlights dose‑escalation and safety milestones for 177Lu‑RAD202 in HER2‑positive advanced solid tumors and 177Lu‑RAD204 in PD‑L1‑positive cancers including NSCLC, SCLC, triple‑negative breast cancer, cutaneous melanoma, head and neck squamous cell carcinoma and endometrial cancer.
Company releases provide interim data on tumor uptake, concordance with MRI, safety profiles and recommendations from Data Safety and Monitoring Committees, as well as regulatory events such as IND clearance for RV‑01 (Betabart), a Lu177‑B7H3 monoclonal antibody developed through Radiopharm Ventures with MD Anderson Cancer Center, and ethics approval to initiate the RAD402 prostate cancer trial. Financial and corporate news items include capital raisings, cash flow reports, board changes and strategic supply agreements for radioisotopes like Lutetium‑177 and Terbium‑161.
This news feed aggregates these disclosures so investors and researchers can review clinical trial milestones, regulatory designations, joint venture developments and financing activities related to Radiopharm Theranostics. For ongoing insight into the company’s oncology radiopharmaceutical pipeline, users can monitor this page for new releases and regulatory filings linked to RADX.
Radiopharm Theranostics (ASX:RAD) has received ethics approval in Australia to initiate a Phase 1 First-In-Human therapeutic trial of 177Lu-RAD202 for treating HER2-expressing solid tumors. The open-label trial, named 'HEAT' (HER2 Antibody Therapy with Lutetium-177), will evaluate safety and preliminary clinical activity in patients with HER2-expressing advanced cancers.
The multicenter study follows previous successful data showing safety and biodistribution of 99mTc-labeled RAD 202 in humans. Preclinical findings with 177Lu-labeled RAD 202 demonstrated tumor growth inhibition and significantly prolonged survival time in HER2-positive xenografts. The treatment targets HER2, which is overexpressed in breast cancer and other solid tumors.
Radiopharm Theranostics announces the listing of its American Depositary Shares (ADSs) on the Nasdaq Capital Market under the ticker symbol RADX, effective November 27, 2024. Each ADS represents 300 ordinary shares, complementing the company's primary ASX listing. The Nasdaq listing was achieved without an associated capital raise, with Deutsche Bank Trust Company Americas appointed as depositary. Currently, 21% of Radiopharm's shareholders are US-based. The company expects initial trading volume may be as existing shareholders convert ordinary shares to ADSs.