Radiopharm Theranostics (ASX:RAD, Nasdaq:RADX) Secures FDA IND Nod for Phase I Trial of RV-01 in Solid Tumors

July 28, 2025 11:11 AM AEST | By Sonal Goyal

Google News:

Radiopharm Theranostics (ASX:RAD, Nasdaq:RADX) Secures FDA IND Nod for Phase I Trial of RV-01 in Solid Tumors — Image source: Company Update

Recent News

Sysco Supports Texas Flood Communities With Food and Response

Resilient Aquatic Strategies: Driving Corporate Innovation, Resource S...

BIER Member Spotlight: Jade Mahuzier

Blockchain for Good Alliance Leads Global Digital Cooperation at UN IG...

Highlights

Radiopharm Theranostics has received the US FDA IND approval to begin a Phase I clinical trial for RV-01 (Betabart).

RV-01 is a first-in-class Lu177-conjugated monoclonal antibody targeting B7-H3, a protein highly expressed in solid tumors and minimally in normal tissues.

The first-in-human trial is expected to begin in the fourth quarter of 2025.

Radiopharm Theranostics Limited (ASX:RAD, Nasdaq:RADX), a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its radiotherapeutic candidate, RV-01 (Betabart).

This approval enables Radiopharm Theranostics to initiate a Phase I first-in-human clinical trial targeting solid tumors. The study is expected to begin in the fourth quarter of 2025 in collaboration with the MD Anderson Cancer Center.

RV-01, a Lu177-B7H3 monoclonal antibody, is a first-in-class targeted radiopharmaceutical targeting the 4Ig isoform of B7-H3, an immune checkpoint molecule commonly overexpressed in multiple tumor types but largely absent in healthy tissues.

RAD shares were trading 4.35% higher at AUD 0.024 per share at the time of writing on 28 July 2025.

Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (Kalkine Media, we or us), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.