Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions
Telix Pharmaceuticals Limited - American Depositary Shares (TLX)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides a precision medicine portfolio update in relation to: TLX591-CDx (Illuccix® in approved jurisdictions, 68Ga-PSMA-11): Positive data from Phase 3 study in Chinese patients provides the basis for near-term NDA submission in China.TLX101-CDx (Pixclara®1, 18F-floretyrosine), PET imaging candidate for glioma: Following collaborative interactions with the FDA, finalizing NDA resubmission and expect to provide a further near-term update on FDA acceptance of the file.TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab), PET imaging candidate for ccRCC: Positive Type A meeting held with the FDA to align on remediation of CMC deficiencies identified in the CRL. Further details on each of these updates is provided below. Illuccix China Phase 3 Registration StudyTelix is pleased to announce positive top-line results from its Phase 3 registration stud
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- Shareholders of Telix Pharmaceuticals Ltd. Should Contact The Gross Law Firm Before January 9, 2026 to Discuss Your Rights – TLXGlobeNewswire
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- TLX Investors Have Opportunity to Lead Telix Pharmaceuticals Limited Securities Fraud Lawsuit with the Schall Law FirmGlobeNewswire
- Portnoy Law Firm Announces Class Action on Behalf of Telix Pharmaceuticals Limited InvestorsGlobeNewswire
- 21% TLX PLUNGE: Hagens Berman Urges Telix Investors to Act by Jan. 9 in Class Action Suit Over SEC Subpoena & FDA CRL on Manufacturing FailuresPR Newswire
TLX
Sec Filings
- 12/22/25 - Form 6-K
- 12/17/25 - Form 6-K
- 12/8/25 - Form 6-K
- TLX's page on the SEC website