The Telix Pharmaceuticals Ltd (ASX: TLX) share price is under the spotlight after announcing a negative update from the US FDA.
Telix Pharmaceuticals describes itself as a biopharmaceutical company that’s focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. It’s headquartered in Melbourne and has operations in the US, Brazil, Canada, Belgium, Switzerland and Japan.
It’s developing a portfolio of clinical and commercial stage products that aim to help significant unmet medical needs in oncology and rare diseases.
Telix Pharmaceuticals’ FDA update
Telix announced it has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for TLX101-CDx, an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.
The FDA has received the application and ruled that it cannot be approved in its current form. The FDA said additional confirmatory clinical evidence is required to progress the application.
Telix notes this occurred despite a “robust consultation process prior to submission and during review” of the application.
The FDA said it hasn’t raised any concerns about the product’s safety. Telix is going to request a hearing with the FDA to review the basis for its decision and is assessing clinical strategies available to add to its application package in the near-term.
Telix said this is a disappointing outcome for American glioma patients. It noted that FET-PET is recommended medical best practice in relevant international oncology practice guidelines and is used extensively in other parts of the world.
The ASX healthcare share also said the FDA has granted TLX101-CDx orphan drug and fast track designation, a “tacit acknowledgement of the drug candidate’s importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.”
Management commentary
The Telix Managing Director and CEO Dr Christian Behrenbruch said:
We are committed to commercializing TLX101-CDx and fulfilling the unmet need to improve imaging to enable timelier and more accurate decisions for the clinical management of glioma. We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studies. Our immediate focus is understanding the FDA’s feedback and augmenting our submission with additional data to satisfy the Agency as soon as possible.
Final thoughts on Telix Pharmaceuticals shares
While this is not ideal, it will hopefully just be a short-term hurdle for the company to overcome. There is additional uncertainty for international healthcare companies considering the new US administration. It will be an interesting process for Telix to gauge how easy it is to work with the new US officials.
This news does not impact Telix’s FY25 guidance because guidance excludes revenue forecasts from unapproved products.
It’s not one of the ASX growth shares I’m currently looking to invest in because biotech businesses isn’t an area I have great knowledge in.
