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BUZZ-Morningstar expects FDA nod for Telix Pharmaceuticals' Pixclara to be delayed, not denied

Reuters
Apr 29, 2025
BUZZ-Morningstar expects FDA nod for Telix Pharmaceuticals' Pixclara to be delayed, not denied

** Morningstar analysts expect Telix Pharmaceuticals TLX.AX to receive a delayed regulatory approval, instead of a denial, for co's Pixclara, an imaging agent for glioma brain cancer

** Telix on Monday said that the U.S. Food and Drug Administration declined to approve its new drug application for Pixclara

** FDA has requested additional clinical evidence to progress the application

** Brokerage expects the product to make first sales and contribute to earnings from 2026, instead of 2025

** Adds, it sees no material effect on co over the medium term

** Stock rated "buy" on average; median price target stands at A$35, per data compiled by LSEG

** Stock last up 8.4% YTD

(Reporting by Jasmeen Ara Shaikh in Bengaluru)

((JasmeenAraIslam.Shaikh@thomsonreuters.com))

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