TLX Stock Surges Overnight After FDA Agrees To Review Brain Cancer Imaging Agent Application

• The NDA application was resubmitted to the U.S. FDA for approval, and the company expects the PDUFA goal date of September 11, 2026.
• The TLX101-Px(Pixclara) approval will help in the treatment of both adult and pediatric patients 
• The pharma major has not included revenue contribution from this imaging agent into their FY26 financial guidance

U.S.-listed shares of Telix Pharmaceuticals rose nearly 9% overnight heading into Friday after the FDA accepted a New Drug Application(NDA) for its TLX101-Px1, a brain cancer imaging agent. 

The Australian company said the approval was given for the resubmission of its application, sending shares on the ASX surging over 7% on Friday, their best session in a month.

The company now expects to receive the U.S. FDA's Prescription Drug User Fee Act (PDUFA) decision on the application on September 11, 2026. The company said that the TLX101-Px (Pixclara) has already been granted Orphan Drug and Fast Track designations by the FDA. 

If approved, the imaging agent would cover a large unmet medical need for the “characterization of recurrent or progressive glioma from treatment-related changes in both adult and pediatric patients.” That means it will be able to distinguish between the recurrence of brain cancer and the side effects of the treatment, which otherwise could look similar in standard imaging.

“Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States.” Telix CEO Kevin Richardson said in a statement.

The pharma company also stated that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for TLX101-Px. It hopes to expand access to its advanced brain imaging agent in Europe.  The company has excluded revenue from this imaging agent from its FY26 financial guidance.

What’s The Word On Wall Street About TLX?

On April 6, the company announced its first-quarter 2026 results, and its precision medicine revenue grew 16% from the year-ago quarter. It was driven by an uptick in Gozellix, a prostate cancer imaging agent. 

Following the results, H.C. Wainwright reiterated its Buy rating on the stock with a target price of $20.00. TLX’s 52-week high was $20, and at current levels the stock is roughly 46% below that. Of the 14 analysts on the street, 9 recommend ‘Buy,’ and 5 recommend ‘Strong Buy, as per Koyfin data.

How Did The Retail Traders React?

On Stocktwits, there has been an overall positive sentiment surrounding the stock. Retail investors have a ‘Bullish’ sentiment, while the message volumes are also ‘High.’

One user on Stocktwits mentioned that he sees the stock surging over 40% from the last close.

https://stocktwits.com/JFais/message/649836353

Shares of Telix Pharma have risen about 30%, year to date.

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