Telix shares sink after FDA blocks approval for glioma imaging agent
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More news: Shares in Telix Pharmaceuticals slumped in early trade after the the US Food and Drug Administration said it could not approve a new drug application made by the biopharmaceutical company.
Telix shares were down 5.9% to $26.89 at 11:10am AEST, having advanced more than 80% over the last 12 months.
FDA setback for Telix Pharmaceuticals' glioma imaging agent
The news: Telix Pharmaceuticals said it received a "disappointing outcome" from the US Food and Drug Administration (FDA), after the regulator said it could not approve the company's new drug application for an investigational agent for the imaging of glioma.
The context: The regulator said additional clinical evidence is required to progress the application for the agent, TLX101-CDx, an imaging agent for the rare and life-threatening brain cancer.
Telix said its "immediate focus" is understanding the FDA's feedback and including additional data to its submission.
The company noted the decision does not impact the company's financial guidance, which excludes revenue forecasts from unapproved products.
What they said: "We are committed to commercialising TLX101-CDx and fulfilling the unmet need to improve imaging to enable timelier and more accurate decisions for the clinical management of glioma," said Telix managing director and group CEO Christian Behrenbruch.
"We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including company-led studies."
The source: ASX
