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Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

Key Takeaway: Radiopharm Theranostics has announced that it has received Investigational New Drug (IND) approval from the US FDA. This approval enables the company to initiate a Phase I therapeutic clinical study targeting B7H3 with its drug Betabart (RV-01). This marks a significant step forward in their clinical development efforts.
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POSITIVE FACTORS

  • Radiopharm Theranostics has received IND approval from the FDA.
  • The approval allows the initiation of a Phase I therapeutic clinical study.
  • The study targets B7H3 with Betabart (RV-01), indicating progress in cancer treatment.

Full Press Release Details

• Announcements , Updates
• PDF
• July 29, 2025
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Frequently Asked Questions

What is the purpose of the Phase I study?

The Phase I study aims to target B7H3 using the drug Betabart (RV-01).

Who approved the IND for Radiopharm?

The IND was approved by the US FDA.

What is Betabart (RV-01)?

Betabart (RV-01) is a therapeutic drug developed by Radiopharm Theranostics.

When was the IND approval announced?

The IND approval was announced on July 29, 2025.

Last updated: Jul 29, 2025