Telix Pharmaceuticals Ltd (ASX: TLX) shares have dropped another 2.54% in Tuesday morning trade. At the time of writing, the shares are trading at $12.84 a piece.
Over the past month, the global biopharmaceutical company's shares have plunged 9.61% and they've crashed 58.6% from their all-time high of $21.14 in February this year.
What happened to Telix Pharmaceuticals' shares?
The commercial-stage biopharmaceutical company's shares plunged following an issue with the United States Food and Drug Administration (FDA).
At the time, the FDA said it had identified deficiencies related to the Chemistry, Manufacturing, and Controls (CMC) package. The FDA said it would seek additional data before moving forward with Telix's Biologics License Application (BLA) for the company's TLX250-CDx (Zircaix) product.
Zircaix is a PET imaging agent designed to non-invasively diagnose and characterise clear cell renal cell carcinoma (ccRCC), the most common kidney cancer, by targeting the Carbonic Anhydrase IX (CAIX) protein.
The company provided a statement on 28 August, saying it believes these concerns are readily addressable and submission remediation will begin immediately.
In early September, the company announced that it had agreed on a resubmission pathway with the FDA for its affected products. The company plans to resubmit the new drug application during Q4 2025.
Following the regulatory setbacks, brokers downgraded Telix Pharmaceuticals' stock due to increased risk and pushed-out revenue expectations. And investor sentiment was slashed too, with investors selling their shares in the face of uncertainty.
Is there any upside ahead, or will the shares keep falling?
I think the tide is about to turn for the beaten-down ASX 200 stock. The company has already had huge success with its flagship prostate cancer imaging product, Illuccix. Once it receives approval for Zircaix, it has the potential to open another multi-billion-dollar global market.
And that's not all. The company is developing new radiopharmaceutical candidates targeting brain cancer and other cancers, too. If everything progresses well, Telix Pharmaceuticals could well have a long road of growth ahead.
What do the experts think?
TradingView data shows 14 out of 15 analysts have a buy or strong buy rating on the shares, with a maximum target price of $34.30. At the time of writing, that represents a whopping potential 166.38% upside for investors over the next 12 months.
UBS is bullish on the stock. It has a buy rating on the ASX biotech share, with a price target of $31.
Bell Potter is also positive on Telix Pharmaceutical shares. It has a buy rating and $23.00 price target on the stock, which based on the current share price, implies a potential upside of 79.1% over the next 12 months.
RBC Capital is more reserved with a $17 price target on the shares, although this still implies a potential 32.4% upside at the time of writing. The broker said that the company has a large development pipeline but added that shareholders might have to wait some time for earnings and free cash flow to tick up.
