Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate
Telix Pharmaceuticals Limited - American Depositary Shares (TLX)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3. Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET
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News
- Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging CandidatePR Newswire
- Telix Pharmaceuticals (TLX) was downgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=TLX&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> from "hoMarketBeat
- ProstACT Global Phase 3 Study (Part 1) Achieves Primary ObjectivesGlobeNewswire
- ProstACT Global Phase 3 Study (Part 1) Achieves Primary ObjectivesPR Newswire
- Telix Pharmaceuticals (TLX) was upgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=TLX&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> from "sellMarketBeat
TLX
Sec Filings
- 3/16/26 - Form 6-K
- 3/10/26 - Form 6-K
- 2/20/26 - Form F-3ASR
- TLX's page on the SEC website