RADX

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

SYDNEY, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing tumors. This follows a positive recommendation from the Safety and Monitoring Committee (SMC), an independent multidisciplinary committee, to advance to the 70 mCi dose of RV-01. RV-01 is a 177Lutetium-tagged engineered monoclonal antibody, des

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

Advancing RAD202 Phase 1 trial to next dose level of 180mCi in patients with HER2+ advanced solid tumors Previous diagnostic study of RAD202 in ten HER2-positive breast cancer patients demonstrated clinical proof-of-concept with positive safety and biodistribution SYDNEY, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic a

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint 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 SYDNEY and MALVERN, Pa., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1st , 2026, to align

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

Reported positive results from the Phase 2b clinical trial of imaging agent RAD 101, showing 93% of evaluable patients treated with RAD 101 achieved the primary endpoint  Plans to initiate Phase 3 registrational trial of RAD 101 in Q4 2026 Raised approximately $12.5M through an institutional offer and launched a $6million Share Purchase Plan, post balance date SYDNEY, July 31, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced financial results for the quarter ended June 30,

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

424B5 - Radiopharm Theranostics Ltd (0001949257) (Filer)

NEW YORK and SYDNEY, July 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics Limited (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announces that it has entered into a Securities Purchase Agreement ("SPA") with certain U.S. accredited institutional investors to issue, in a registered direct offering, 1,281,646 American Depositary Shares ("ADSs"), representing 384,493,800 ordinary shares (with each ADS representing 300 ordinary shares) of the Company, at an offering price of US$3.16 per ADS, to raise aggregate gross proceeds of app

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

424B5 - Radiopharm Theranostics Ltd (0001949257) (Filer)

First RECIST-confirmed durable Partial Response at current highest dose level #3 (90mCi) with the patient remaining progression free beyond seven months Second patient dosed remains progression free on treatment with RAD204 with early tumor shrinkage observed after first treatment RAD204 is generally well-tolerated with no dose-limiting toxicities observed in any of the dosing cohorts thus far SYDNEY and MALVERN, Pa., July 22, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint. 14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14) Sensitivity (secondary objective). Specificity data will be available in Q4 2026. The Company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026 The imaging Brain Metastases total addressable market is ~$600+m for which there is no currently approved PET product SYDNEY, July 22, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiop

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

H.C. Wainwright initiated coverage of Radiopharm Theranostics with a rating of Buy and set a new price target of $6.00

6-K - Radiopharm Theranostics Ltd (0001949257) (Filer)

Issued on behalf of GT Biopharma, Inc. From bispecific ADCs at IDEAYA to a GSK partnership at Summit, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology — and a new natural killer cell engager just entered the clinic SAN FRANCISCO, May 14, 2026 (GLOBE NEWSWIRE) -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy ti