The FDA just told Telix “it’s not me, it’s you” for the second time this year… 

Telix just took another punch to the gut from the FDA. For the second time in less than a year, the agency has swatted away the company’s biologics license application for Zircaix, a PET imaging agent meant to finally give kidney cancer diagnostics something better than a biopsy needle and a prayer.

(Source: Giphy) 

The official line of the rejection is thus: manufacturing screw-ups. The FDA’s Complete Response Letter flagged “Chemistry, Manufacturing, and Controls” (CMC) issues and slapped two of Telix’s third-party suppliers with deficiency notices. Translation: The FDA doesn’t trust Telix can scale what it made in its trial to something safe and consistent in the real world. That means no U.S. launch until at least early 2027.

(Source: Benzinga) 

Naturally, investors weren’t exactly thrilled, shares were yeeted -16% as William Blair cut its fair value by a couple points and warned the “second CRL will likely influence sentiment on management’s regulatory execution.” No kidding.

However, it’s not like Zircaix is some run-of-the-mill me-too drug either. If approved, it would be the first PET imaging agent designed specifically for kidney cancer in the U.S., binding to a protein (CAIX) present on 95% of clear cell renal cell carcinoma tumors. In other words, the science is there… but in biotech, science only matters if you can bottle it. And right now, Telix can’t.

(Source: Giphy) 

The company insists the concerns are “readily addressable.” CEO Christian Behrenbruch chalked it up to the messy reality of radiopharmaceuticals: complex supply chains, exotic isotopes, regulators trying to wrap 1950s playbooks around 21st-century tech. That may be true, but this is still the second public face-plant in under 12 months. For instance, back in July 2024, the FDA wouldn’t even accept Zircaix’s filing because Telix couldn’t prove sterility in its radiopharmacies. Earlier this year, its glioma imaging candidate Pixclara also got rejected. Talk about fumbling the bag. 

And yet, the irony is that Telix actually has some things going right. Gozellix, its prostate cancer imaging product, is expected to secure Medicare “pass-through” reimbursement on October 1… a catalyst that should keep revenue guidance intact for 2025. Core business lines like Illuccix are still throwing off cash. And although analysts see the company holding up near-term… the missed timelines for Zircaix mean Telix investors will be only be hearing “eat sh*t” for another two years. 

(Source: Giphy) 

For investors, the playbook is pretty simple. And that’s the story hasn’t broken… yet, but the clock is ticking. If Telix can clean up its manufacturing and get Zircaix back on track, it’s sitting on a genuinely valuable franchise that could diversify beyond prostate cancer. If not? It risks becoming another case study where the science worked but the supply chain didn’t. Of course, anything can happen… but for now, stay clear of the falling knife (or just BTFD). Your choice… not financial advice. Until next time, friends… 

At the time of publishing, Stocks.News does not hold positions in companies mentioned in the article.