Telix Pharmaceuticals (TLX) Announces That US FDA Approves Label Expansion for Illuccix

Telix Pharmaceuticals Limited (NASDAQ:TLX) is one of the 7 Best ASX Stocks to Buy Now. On June 23, the company announced that the US FDA approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting.

Telix Pharmaceuticals (TLX) Announces That US FDA Approves Label Expansion for Illuccix®

A closeup of pills in a pharmacy, representing the high quality medications of the company.

This update gets applied to Illuccix’s third indication, for selecting patients who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products. The label expansion follows the approval by the US FDA of an expanded label for Pluvicto® (lutetium Lu177 vipivotide tetraxetan) for use in metastatic castration-resistant prostate cancer (mCRPC) patients after the treatment with androgen receptor pathway inhibitor (ARPI) therapy and before chemotherapy. Now that RLT is approved for earlier usage in the patient journey, the clinical utilization of Illuccix® is projected to increase by a minimum of 20,000 scans annually.

In Q1 2025, Telix Pharmaceuticals Limited (NASDAQ:TLX)’s unaudited revenue came in at ~$186 million, representing an increase of 62% over the prior year corresponding quarter (Q1 2024: $115 million) and a QoQ rise of 31% (Q4 2024: $142 million). This includes $151 million from global sales of Illuccix® and $33 million from RLS Radiopharmacies (RLS) since the acquisition was completed on 27 January 2025.

Telix Pharmaceuticals Limited (NASDAQ:TLX) stated that Illuccix continued to gain market share and maintain price stability amidst competition. Furthermore, Telix Pharmaceuticals Limited (NASDAQ:TLX) happens to be the only company with 2 FDA-approved PSMA-PET imaging agents – Illuccix and Gozellix. This allows it to broaden patient reach and maximize choice for the customers. Telix Pharmaceuticals Limited (NASDAQ:TLX)’s stock has a consensus one-year price target of $22.90.

While we acknowledge the potential of TLX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than TLX and that has 100x upside potential, check out our report about this cheapest AI stock.

READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now

Disclosure: None.