TLX101-Px

July 21, 2026: Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) provided a Q2 2026 (quarter ended June 30, 2026) market update highlighting multiple regulatory, clinical, and filing catalysts across its radiopharmaceutical portfolio.

Therapeutics

• TLX591-Tx (¹⁷⁷Lu rosopatamab tetraxetan), ProstACT Global Phase 3 in mCRPC: FDA confirmed Part 1 safety data are sufficient to progress to Part 2 in the U.S., with alignment on Part 2 protocol/statistical plan and safety monitoring; U.S. Part 2 start remains subject to FDA review of an IND amendment. Part 2 continues enrolling outside the U.S. and has approval to commence in China.
• TLX597-Tx (¹⁷⁷Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA (mCRPC) completed enrollment (120 patients); first patients dosed in OPTIMAL-e Phase 2 in metastatic hormone-sensitive prostate cancer.
• TLX250-Tx (¹⁷⁷Lu girentuximab tetraxetan): first patient dosed in LUTEON pivotal trial in advanced clear cell renal cell carcinoma.
• TLX101-Tx (¹³¹I-iodofalan): first cohort enrolled in IPAX BrIGHT pivotal trial in recurrent glioblastoma; IPAX-2 Phase 1 in newly diagnosed glioblastoma completed enrollment with no dose-limiting toxicities observed to date.

Precision Medicine / Regulatory

• BiPASS Phase 3 (Illuccix®/Gozellix®): enrollment nearing completion (338 patients) for initial prostate cancer diagnosis (pre-biopsy) to support regulatory submissions in the U.S., Europe, and Australia.
• TLX591-Px (Illuccix) Japan: Phase 3 registrational enrollment completed; NDA preparation underway; PMDA Conditional Approval application under review.
• TLX101-Px (Floretyrosine F 18 / ¹⁸F-FET): FDA accepted resubmitted NDA for Pixclara® and set a PDUFA goal date of September 11, 2026; IND submitted for Pixclara Phase 3 study to expand indication to diagnosis of brain metastases. Europe: MAA for Pixlumi® validated/accepted for review.
• Zircaix® (TLX250-Px, ⁸⁹Zr-DFO-girentuximab): BLA resubmission in the U.S. expected “shortly,” with final CMC documentation nearing completion.

Business catalysts: strategic collaboration with Regeneron (US$40M non-refundable payment) to develop/commercialize next-generation radiopharmaceutical therapies (initially lung cancer); FY2026 revenue guidance reiterated (US$950–970M plus US$40M other income; >US$1B total).