FDA Accepts NDA for TLX101-Px (Pixclara®)
Telix Pharmaceuticals Limited - American Depositary Shares (TLX)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and INDIANAPOLIS, April 10, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara®2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026. The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients5. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines®6 – and TLX101-Px has been granted Orphan Drug7 and Fast Track8 designations by the FDA. “There remains a critical unmet need in improving our ability to image residual glioma a
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TLX
News
- Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent GlioblastomaGlobeNewswire
- Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent GlioblastomaPR Newswire
- Telix Successfully Prices and Upsizes US$600 Million Convertible BondsPR Newswire
- Telix Successfully Prices and Upsizes US$600 Million Convertible BondsPR Newswire
- Telix Refinances Convertible BondsPR Newswire
TLX
Sec Filings
- 4/14/26 - Form 6-K
- 4/14/26 - Form 6-K
- 4/13/26 - Form 6-K
- TLX's page on the SEC website