Telix Pharmaceuticals leads ASX 200 gains on FDA progress
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More news: Telix Pharmaceuticals was the best performer on the ASX 200 in early trade after the biotech reached an agreement with the US Food and Drug Administration on the resubmission pathway for its glioma imaging agent TLX101-CDx.
Telix shares were up 5.2% to $14.31 at 10:50am AEST, having jumped more than 10% at the open. The stock is down 18.5% over the last 12 months.
Telix and FDA agree resubmission pathway for glioma imaging agent
The news: Telix Pharmaceuticals has reached an agreement with the US Food and Drug Administration on the resubmission pathway for its investigational agent TLX101-CDx for the imaging of glioma, a rare and life-threatening brain cancer.
The context: Telix said it has received detailed feedback from the FDA regarding the resubmission package, which will include additional confirmatory efficacy study analysis of existing data.
Based on the feedback, Telix said it believes the study will meet the FDA's request for additional confirmatory evidence to supplement its New Drug Application (NDA), and address review matters cited in the FDA's Complete Response Letter (CRL).
The FDA has acknowledged the unmet medical need, Telix said, and has indicated that an expedited review is likely to be granted on this basis.
Telix shares slumped in April after the FDA said it could not approve the biotech's NDA for the investigational agent.
What they said: "As previously advised, Telix had multiple options for delivering additional data requested by the FDA in the CRL response," said Telix group chief medical officer David Cade.
"This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the NDA.
"We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the US to support improved diagnosis and management of glioma."
The source: ASX
