Telix Pharmaceuticals Ltd (ASX: TLX) shares are charging higher today.
Shares in the S&P/ASX 200 Index (ASX: XJO) diagnostic and therapeutic product developer closed yesterday trading for $13.04. In afternoon trade on Tuesday, shares are swapping hands for $13.54 apiece, up 3.8%.
For some context, the ASX 200 is up 0.8% at this same time.
With today's intraday gains factored in, shares in the ASX 200 healthcare stock are now up an eye-popping 56.9% since notching a multi-year closing low of $8.63 on 16 February.
Despite that meteoric rise, Telix shares remain down 48.9% over 12 months. The stock has faced investor pushback on several fronts over the past year, including regulatory filing issues for some of its leading products with the US Food and Drug Administration (FDA).
But with the company actively engaging with the FDA, MPC Markets' Mark Gardner believes the market is undervaluing this $4.6 billion ASX stock (courtesy of The Bull).
Image source: Getty Images
Should you buy Telix shares today?
"The company's prostate imaging agent is generating strong sales in the United States," said Gardner, who has a buy recommendation on Telix shares.
According to Gardner:
The near-term story is about brain cancer imaging. The company recently re-submitted its drug application to the US Food and Drug Administration (FDA) for Pixclara, an imaging agent for a particularly aggressive form of brain cancer.
Telix reported on that resubmission on 16 March. While shares finished lower on the day, the ASX 200 stock is now up 23.4% since market close on 16 March.
Gardner continued:
The FDA has given it priority status, and Telix has gone through a formal meeting to address every question raised in its previous application. In our view, a re-submission isn't a setback, but the last step before approval.
Summing up his buy recommendation on Telix shares, Gardmer said, "We believe the market isn't pricing in the benefits of a potentially successful FDA outcome."
What's happening with Pixclara?
Commenting on the company's ongoing engagement with the FDA on its brain cancer imaging agent, which could support Telix shares longer-term, Telix chief medical officer David Cade said:
We appreciate the FDA's recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting.
Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the US can benefit from this important patient management tool.
Telix said that it expects the FDA review of Pixclara to progress in the coming months.
