Are Telix shares a buy after its big US FDA news?

Telix announced some big news this week.

Telix Pharmaceuticals Ltd (ASX: TLX) shares have been on fire this week.

Despite the market weakness, the radiopharmaceuticals company's shares have rocketed around 14% higher.

The catalyst for this has been news that the company's Pixclara product has been granted US FDA approval.

So, should you be buying Telix shares as well because of this big news? Let's find out what Bell Potter thinks.

Male and female scientists analysing data on a computer.

Image source: Getty Images

What is the broker saying?

Bell Potter was pleased with the Pixclara news, highlighting that Telix is entering a new era with revenues set to jump in FY 2027. It said:

The FDA's approval of the new drug application for Pixclara (floretyrosine F18 aka FET-PET) heralds a new era for TLX, expanding its revenue base beyond the PSMA imaging. In fact, TLX now has multiple revenue streams inclusive of it is isotope manufacturing business, with FY27 revenues now likely to expand well beyond the US$1bn mark .

Speaking about the product, the broker adds:

The work now commences to execute on the commercialisation strategy commencing with the establishment of reimbursement and the appointment of radiopharmaceutical networks for distribution.

We expect strong demand from the outset as FET-PET is the standard of care for the management of gliomas outside of the US. The drug has been available to a limited extent under the expanded access program in the US and there is a highly concentrated user group amongst radiation oncologists. The premium reimbursement relative to reimbursement on most other nuclear medicine exams will help prioritise FET-PET for machine time.

Should you invest?

According to the note, in response to the news, Bell Potter upgraded Telix shares to a buy rating with a $19.00 price target.

Based on its current share price of $17.75, this implies potential upside of 7% for investors.

Commenting on its investment thesis, it said:

First revenues expected 2Q27. Revenues will be modest in the initial instance and not material to overall revenue growth in the short term. Despite this, the Pixclara approval is an important catalyst, particularly if the label expands to the larger brain metastases indication. We had previously included revenues from Pixclara in forecasts, hence no changes to earnings required. We upgrade our recommendation from Hold to Buy, PT $19.00.

Overal, the broker appears to see potential for Telix shares to keep climbing in the near term. Though, the easy gains appear to be behind them.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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