Telix files EU approval request for TLX101-Px

Telix Pharmaceuticals Limited submitted a European Marketing Authorization Application for its product candidate TLX101-Px, which is designed for brain cancer imaging.

Rhea-AI Filing Summary

Telix Pharmaceuticals Limited submitted a European Marketing Authorization Application for its product candidate TLX101-Px, which is designed for brain cancer imaging. The company reported this regulatory milestone to U.S. investors by furnishing on Form 6-K the related announcement it filed with the Australian Securities Exchange.

Insights

Biotech regulatory specialist

Telix advances TLX101-Px with a European approval filing.

Telix Pharmaceuticals Limited has submitted a European Marketing Authorization Application (MAA) for TLX101-Px, a brain cancer imaging product, and furnished this information to U.S. markets via Form 6-K.

An MAA is a key step toward commercial approval in Europe, following earlier development and clinical work. While this filing does not include financials, it signals that Telix believes it has sufficient data to seek authorization for TLX101-Px.

Future disclosures or regulatory updates about the progress or outcome of this European application would help clarify potential timing and commercial impact for TLX101-Px in brain cancer imaging.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Telix Pharmaceuticals Limited (TLX) report in this Form 6-K?

Telix reported that it submitted a European Marketing Authorization Application for TLX101-Px, a brain cancer imaging product. The company furnished to U.S. investors the same announcement it filed with the Australian Securities Exchange as an exhibit to this Form 6-K.

What is TLX101-Px mentioned by Telix Pharmaceuticals Limited (TLX)?

TLX101-Px is described as a brain cancer imaging product for which Telix has submitted a European Marketing Authorization Application. The filing does not detail clinical data or commercial plans but highlights that this product candidate has advanced to a formal European approval request.

Which regulatory step in Europe did Telix (TLX) take for TLX101-Px?

Telix submitted a European Marketing Authorization Application for TLX101-Px, seeking approval to market the brain cancer imaging product in European markets. This is a formal regulatory step following development and signals Telix is pursuing commercialization in Europe, subject to regulatory review and decision.

How did Telix Pharmaceuticals Limited (TLX) communicate the TLX101-Px update to investors?

Telix communicated the update by filing a Form 6-K in the United States that attaches its Australian Securities Exchange announcement titled “Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging” as an exhibit, making the same information available to U.S. investors.

Does this Telix (TLX) Form 6-K include financial results or earnings data?

No, this Form 6-K focuses on a regulatory milestone for TLX101-Px and does not present financial statements or earnings information. It primarily serves to furnish the European Marketing Authorization Application update that Telix announced on the Australian Securities Exchange to U.S. market participants.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 02/18/2026 - 09:12 AM Learn about SEC filing dates

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 OF

THE SECURITIES EXCHANGE ACT OF 1934

For the month of February, 2026

Commission File Number: 001-42128

Telix Pharmaceuticals Limited

(Translation of registrant’s name into English)

55 Flemington Road

North Melbourne, Victoria 3051, Australia

(Address of principal executive offices)

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 ☐

1

INFORMATION CONTAINED IN THIS FORM 6-K REPORT

On February 18, 2026 (Melbourne, Australia), Telix Pharmaceuticals Limited filed an announcement with the Australian Securities Exchange titled “Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging,” which is attached to this Form 6-K as Exhibit 99.1.

99.1 Press Release – February 18, 2026

2

SIGNATURES

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.

	Telix Pharmaceuticals Limited
Date: February 18, 2026	By:	/s/ Genevieve Ryan
		Name: Genevieve Ryan
		Title: Company Secretary

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EX-99.1 395 B