Telix shares drop on FDA application setback
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The news: Shares in Telix Pharmaceuticals fell after the US Food and Drug Administration (FDA) declined to accept its biologics license application (BLA) for a renal cancer imaging agent.
The numbers: Telix said the FDA identified a filing issue relating to sterility assurance for its TLX250-CDx candidate. The company expects to complete remedial action within 90 days and resubmit the BLA.
Telix shares were down more than 5% at $18.47 on the news, but have climbed more than 80% so far in 2024.
The context: Telix said it will engage with the FDA to agree on the required submission amendments and said it continues to target a full US commercial launch for TLX250-CDx in 2025. Its phase three trials were completed in 2022 and met all primary and secondary endpoints.
The company said this iwas a non-material delay and confirmed there was no impact on research and development expenditure for 20204 or the revenue guidance for FY24.
Earlier this month, the US FDA accepted Telix’s new drug application for a prostate cancer imaging kit, called TLX007-CDx.
The source: ASX announcement
