Telix Pharma Stock Hits 52-Week Low on FDA Rejection, SEC Probe
Shares tumble as the biopharmaceutical company faces a securities class-action lawsuit tied to manufacturing woes and an ongoing federal investigation.
Shares of Telix Pharmaceuticals Limited (NASDAQ: TLX) plunged to a new 52-week low Tuesday, as investors reacted to a cascade of negative regulatory and legal news that has engulfed the cancer-focused biotechnology firm.
The stock fell approximately 1.6% to $9.03 in morning trading, touching its lowest point in a year and wiping out significant shareholder value. The decline extends a period of intense pressure on the company, which is now grappling with a formal rejection from the U.S. Food and Drug Administration (FDA) for a key imaging agent, an ongoing investigation by the Securities and Exchange Commission (SEC), and a resulting securities class-action lawsuit.
The troubles escalated following the company's disclosure that it had received a Complete Response Letter (CRL) from the FDA for its new drug application for Zircaix (TLX250-CDx), an imaging agent for kidney cancer. According to a company press release, the FDA’s rejection was not related to the drug's clinical data but cited deficiencies in Chemistry, Manufacturing, and Controls (CMC), including issues at third-party manufacturing partners.
This manufacturing setback appears to be at the heart of the company's legal woes. A securities class-action lawsuit was filed against Telix, alleging the company made false and misleading statements between February and August 2025. The lawsuit claims Telix overstated the quality of its supply chain and the progress of its prostate cancer therapeutic candidates, TLX591 and TLX592.
The allegations gained significant weight with the prior revelation of an SEC subpoena, which the company disclosed in July 2025. The federal inquiry seeks documents related to the company's disclosures on the same prostate cancer programs mentioned in the lawsuit, creating a direct link between the regulatory probe and the investor litigation.
The combined impact has sent the company’s market capitalization tumbling to approximately $3.28 billion. The stock is now trading significantly below its 50-day moving average of $10.09 and its 200-day moving average of $14.60, signaling strong bearish momentum.
Despite the barrage of negative headlines and the stock's performance, some market analysts maintain a bullish long-term outlook. The consensus rating remains a 'Strong Buy' with an average price target of around $20.89, according to data from MarketBeat. This suggests Wall Street believes the company's underlying therapeutic platform holds value, provided it can navigate its current manufacturing and legal crises.
For investors, the path forward for Telix is clouded with uncertainty. The company must now resolve the FDA's manufacturing concerns before it can resubmit its application for Zircaix, a process that could be lengthy and costly. Simultaneously, management must contend with the SEC investigation and defend against the class-action lawsuit, both of which carry significant financial and reputational risks.
The market will be closely watching for any updates on Telix's remediation efforts with its manufacturing partners and any further disclosures related to the ongoing legal proceedings. The company's ability to address these fundamental operational and governance challenges will be critical to rebuilding investor confidence and reversing the stock's sharp decline.