The End Brain Cancer Initiative Partners with Telix Pharmaceuticals for TLX101-Px (Pixclara®) and PDUFA Awareness

SEATTLE, WA, UNITED STATES, September 3, 2026 /EINPresswire.com/ — The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of September 11, 2026, for TLX101-Px (Pixclara^®), an investigational PET imaging agent developed by Telix Pharmaceuticals to help doctors evaluate brain cancer. The End Brain Cancer Initiative (EBCI) has partnered with Telix Pharmaceuticals to develop and provide patient disease education around TLX101-Px (Pixclara^®), what a PDUFA date is, and why it matters to patients.

A PDUFA date is the target date established by the U.S. Food and Drug Administration (FDA) for completing its review of a new drug or medical product application and determining whether it can be approved for use in the United States. PDUFA stands for the Prescription Drug User Fee Act, which helps provide the FDA with resources to review new drug applications within established timelines. By the PDUFA target date of September 11th, the FDA is expected to complete its review and may approve TELIX’s application, request additional information or requirements before approval, or take another regulatory action that affects the review timeline. A PDUFA date is therefore not a guaranteed approval date, but it is an important milestone for everyone following the development of a potentially meaningful new option for people affected, in this case, by brain cancer.

Patients, caregivers, healthcare providers, and the general public who would like more information about TLX101-Px (Pixclara^®) or PDUFA should visit https://endbraincancer.org/telix/. People can also directly contact EBCI’s Clinical Research Coordinator and Patient Navigator, Shreya Prakash, at Shreya@EndBrainCancer.org or at 425-436-8688.

About Telix Pharmaceuticals
Telix Pharmaceuticals uses a radioactive isotope as a payload, attached to a targeting agent, such as a small molecule or antibody, with an affinity for targeted biomarkers on the surface of cancerous or diseased cells. Depending on the choice of radioisotope payload, either imaging or therapy can be delivered. This specificity of the targeting agent is designed to concentrate radiation at the tumor sites and to limit off-target tissue exposure. For more information, visit the company’s website at https://telixpharma.com/.

About the End Brain Cancer Initiative
To support/donate to the End Brain Cancer Initiative’s increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org and make a donation today.

The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative or how to sponsor this annual campaign at EndBrainCancer.org.

Dellann Elliott Mydland, End Brain Cancer Initiative, 425-785-8489, Dellann@EndBrainCancer.org

Dellann Elliott Mydland
End Brain Cancer Initiative
+1 425-785-8489
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