Radiopharma firm Telix touts progress after FDA rejects brain imaging agent application
Telix Pharmaceuticals is touting progress in its bid to release a new brain imaging agent after the U.S. Food and Drug Administration dealt it a setback earlier this year.
The Australia-based drug manufacturer is working to release Pixclara, a PET contrast agent for diagnosing glioma, a rare form of brain cancer. In April the company reported the FDA had denied its initial application, contending additional clinical evidence is needed.
However, Telix announced Tuesday it has now reached an agreement with the FDA regarding resubmission of its New Drug Application. Following a meeting with the agency, in which it received detailed feedback, the company will share additional existing data on the drug’s efficacy, hoping to quell regulators’ concerns.
“This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the [New Drug Application],” Dr. David N. Cade, MBA, Telix Group’s chief medical officer, said in a Sept. 9 announcement. “We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the U.S. to support improved diagnosis and management of glioma.”
Telix said the FDA will share an estimated Prescription Drug User Fee Act goal date following successful resubmission of the application. It noted the agency has already acknowledged Pixclara meets an unaddressed medical need, indicating an “expedited review is likely to be granted on this basis.” The company currently is not including the drug in its 2025 revenue guidance, which excludes any yet-to-be-approved imaging products.
The radiopharmaceutical firm also is seeking FDA approval for Zircaix, another PET imaging agent geared toward kidney cancer. Last month, Telix reported the agency also has cited concerns with that application, including documented deficiencies at two third-party manufacturing and supply chain partners.
Meanwhile, the U.S. Securities and Exchange Commission, which enforces laws against market manipulation, has launched an investigation into Telix’s business practices.
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.