Is Telix Pharmaceuticals (ASX:TLX) a Buy After Crashing 63%? Here’s What Investors Should Know

Telix Pharmaceuticals Shares Slide After Regulatory Setbacks

Telix Pharmaceuticals (ASX: TLX) has had a brutal twelve months. Shares have fallen around 63% from their February 2025 all-time high of A$31.97 to current levels near A$11.86. What makes this selloff puzzling is that the company achieved its preliminary FY 2025 revenue guidance of A$1.2 billion (US$804 million), up more than 50% from the year before. For investors watching Australian healthcare stocks, the big question is whether this crash has created a buying opportunity or a warning sign of deeper problems.

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Three FDA Setbacks Explain Why Shares Crashed

The dramatic decline stems from a series of regulatory disappointments that shook investor confidence in management’s execution.

The first blow came in April 2025 when the FDA rejected Pixclara, Telix’s brain cancer imaging product. The agency wanted more clinical evidence before approving it. Shares fell around 10% on the news.

Then, in July 2025, Telix Pharmaceuticals revealed it had received a subpoena from the US Securities and Exchange Commission (SEC). The regulator wanted documents about the company’s prostate cancer drug development. Shares dropped another 13% over two days.

The final and most damaging blow landed in August 2025. The FDA rejected Zircaix, the kidney cancer imaging product, citing manufacturing deficiencies at third-party suppliers. This was actually the second time Telix had faced Zircaix problems with the FDA; the first filing issue occurred back in July 2024. This “second strike” on the same product triggered a 21% share price collapse and sparked class action lawsuits. The lead plaintiff deadline for these lawsuits passed on January 9, 2026, and the litigation remains ongoing.

We believe this pattern of regulatory setbacks- three FDA rejections plus an SEC investigation within one year-  explains why investor confidence has eroded so severely, even as commercial revenue continued to grow.

Commercial Business Remains Strong With Two FDA-Approved Products

Here’s what many investors may be missing. Despite the pipeline troubles, Telix’s commercial business is thriving.

The company has two FDA-approved prostate cancer imaging products generating substantial revenue. Illuccix, approved in December 2021, remains the flagship product. Gozellix, approved in March 2025, received full Medicare reimbursement in October 2025, allowing broader patient access. Telix Pharmaceuticals is the only company worldwide with two FDA-approved PSMA-PET imaging products for prostate cancer.

The numbers tell a strong story. Q4 2025 revenue reached approximately US$208 million, up 46% compared to the same period last year. Illuccix now has approval across 19 European countries plus the UK, with sales underway in Germany, France, and Spain. This commercial momentum suggests the core business remains healthy despite the regulatory noise around pipeline products.

The Investor’s Takeaway for Telix Pharmaceuticals

At current prices around A$11.86, Telix Pharmaceuticals trades at a steep discount to analyst targets. The average 12-month price target sits around A$21-26, suggesting significant upside potential. Most analysts covering the stock maintain buy ratings. Crucially, as of January 2026, Telix has confirmed it has completed a ‘Type A’ meeting with the FDA to address the manufacturing comparability issues for Zircaix, signalling that a resubmission is imminent.

However, real risks remain that investors should consider carefully. The SEC investigation is ongoing and could reveal material issues. The Zircaix and Pixclara rejections mean pipeline products face uncertain timelines. Class action litigation adds headline risk even if the claims prove unsuccessful. And the therapeutic pipeline for prostate cancer treatment carries typical drug development uncertainty.

For growth investors comfortable with volatility, we believe the current valuation looks attractive given the strong commercial revenue growth. A profitable company growing at 50% annually rarely trades at these discounted levels. More cautious investors may prefer waiting for clarity on the regulatory matters before committing capital. Either way, Telix’s unique market position and proven revenue generation suggest this selloff could prove to be an opportunity rather than a permanent impairment.