Recent Updates — RADX
Radiopharm Theranostics announced that positive interim data from its Phase 2b imaging trial of RAD101 was selected for a late-breaking oral presentation at the Society of Neuro-Oncology Annual Meeting. The data demonstrated 93% concordance between RAD101 PET and MRI across all evaluable lesions, meeting the primary endpoint. Additionally, preliminary sensitivity was 86% based on six-month follow-up or biopsy data in 14 patients. The company plans to meet with the FDA on October 1, 2026, to align on a Phase 3 pivotal trial protocol and has partnered with Siemens Healthineers for manufacturing and distribution support. Radiopharm Theranostics operates in the biotechnology industry, developing radiopharmaceuticals for oncology diagnostics and therapeutics.
Radiopharm Theranostics announced positive Phase 1 imaging trial data for RAD301 in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The peptide-based molecule, bound to Gallium-68 and targeting αvβ6-integrin, demonstrated a favorable safety profile, significant tumor uptake in metastases, and low background uptake in the liver, lung, and bowel. These findings support the compound's potential for disease detection and patient selection, prompting plans to advance RAD301 into Phase 2 development. Radiopharm Theranostics is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.
Radiopharm Theranostics announced on August 26, 2026, that it has dosed the first patient in the second cohort of its Phase 1/2a First-In-Human clinical trial for RV-01 (177Lu-Betabart). The Safety and Monitoring Committee recommended advancing to the 70 mCi dose level. RV-01 is a radiopharmaceutical therapeutic targeting B7-H3, developed through a joint venture with MD Anderson Cancer Center. The trial aims to enroll 61 participants across various solid tumors including prostate, colorectal, and lung cancers. Radiopharm Theranostics operates in the biotechnology industry, specifically developing clinical-stage radiotherapeutics for oncology.
Radiopharm Theranostics Limited is seeking shareholder approval at an Extraordinary General Meeting on September 11, 2026, for a capital raise totaling approximately $18.5 million. The transaction includes ratifying the prior issuance of 408,839,531 placement shares and 384,493,800 ADS shares, approving up to 40,000,000 second tranche placement shares at $0.015 per share, and issuing attaching options with a $0.018 exercise price. The raise also involves a Shareholder Participation Plan for up to 666,666,667 shares capped at $10 million, alongside warrants for US subscribers and agent compensation. Funds will support drug manufacturing, clinical trials, and working capital. Radiopharm Theranostics Limited operates in the biotechnology industry, focusing on radiopharmaceuticals for theranostic applications.