FDA shares concerns about new imaging agent, sinking shares for radiopharma firm Telix
Telix Pharmaceuticals saw its shares sink 20% on Thursday after the U.S. Food and Drug Administration revealed concerns about its application for a new imaging agent.
Telix is seeking approval for TLX250-CDx (brand name Zircaix), a novel PET (positron emission tomography) product geared toward kidney cancer. However, the company reported Thursday the FDA is asking for more data about the drug, demonstrating the product used in clinical trials is similar to the one planned for commercial production. Authorities also have documented deficiencies at two third-party manufacturing and supply chain partners, which the drugmaker said will “require remediation” before reapplying for approval.
“Telix believes these concerns are readily addressable and submission remediation will begin immediately,” the Melbourne, Australia-headquartered company said in an Aug. 28 news update, adding that it will request a meeting with the FDA soon. “TLX250-CDx has a Breakthrough Therapy designation and Priority Review status, acknowledging its importance in addressing a significant unmet medical need and clinically demonstrating benefit over available diagnostics,” Telix added later.
Zircaix is indicated for the diagnosis and characterization of clear cell renal cell carcinoma. Telix previously reported one year ago the FDA had denied its initial application for the new imaging agent. The concerns at that time pertained to sterility assurance issues during the drug’s production On Monday, the company said it does not expect the setback to impact its 2025 revenue guidance.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.