Radiopharm Theranostics secures IND approval for RV-01 radiotherapy

Rhea-AI Filing Summary

Radiopharm Theranostics Limited ("RAD") filed a Form 6-K noting that it has received Investigational New Drug (IND) approval from the U.S. FDA for its radiopharmaceutical candidate Betabart (RV-01). The information, first released to the Australian Securities Exchange on 28 July 2025, marks a key regulatory milestone that permits RAD to proceed with U.S. clinical studies. No financial figures, study design specifics, timelines or guidance were provided in this filing.

Positive

• IND approval from U.S. FDA for Betabart (RV-01) advances the asset into clinical development and validates the company’s R&D platform.

Negative

• No financial, timeline or trial design information was provided, limiting visibility into cost, dilution risk and development pace.

Insights

Biotech Equity Analyst

TL;DR – FDA IND clearance is a positive catalyst, but lack of trial details limits immediate valuation impact.

IND approval transitions Betabart (RV-01) from pre-clinical to clinical stage, materially de-risking the asset and expanding RAD’s addressable capital markets. While the filing omits start dates, endpoints or funding needs, the regulatory green light typically lifts sentiment and can unlock partnerships or grant funding. Investors should watch for upcoming protocol disclosures and initial dosing, which will determine cash burn and dilution risk. Overall, the event skews positive, especially for an early-stage radiopharma company.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

For the Month of July 2025

Commission File Number: 001-41621

RADIOPHARM THERANOSTICS LIMITED

(Name of Registrant)

Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒       Form 40-F ☐

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ☐       No ☒

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

RADIOPHARM THERANOSTICS LIMITED

EXPLANATORY NOTE

Radiopharm Theranostics Limited (the “Company”) published one announcement (the “Public Notice”) to the Australian Securities Exchange on July 28, 2025 titled:

-   “RAD receives IND approval from US FDA for Betabart (RV-01)”  

A copy of the Public Notice is attached as an exhibit to this report on Form 6-K.

This report on Form 6-K (including the exhibit hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

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EXHIBITS

Exhibit Number		Description
99.1		RAD receives IND approval from US FDA for Betabart (RV-01)

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	RADIOPHARM THERANOSTICS LIMITED
Date: July 28, 2025	By:	/s/ Phillip Hains
		Phillip Hains
		Company Secretary

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FAQ

What did RADX disclose in its July 2025 Form 6-K?

The company reported FDA IND approval for its radiopharmaceutical candidate Betabart (RV-01).

Why is FDA IND approval important for Radiopharm Theranostics?

IND clearance allows the company to commence human clinical trials in the United States.

Were any financial figures or guidance included in the filing?

No; the Form 6-K contained no revenue, expense or funding guidance.

Does the filing mention trial start dates or study design?

No details on timeline, dosage, endpoints or phase structure were provided.

How might IND approval impact RADX shareholders?

It de-risks the pipeline and can improve access to capital, though actual impact depends on subsequent trial progress.