TLX telix pharmaceuticals limited

Ann: Telix Investor Day Presentation, page-4

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    From A.I

    The Telix Investor Day presentation contains multiple potential share price catalysts, but several standout developments could be considered groundbreaking and therefore likely to move the stock meaningfully. Here are the top ones:



    1.

    Zircaix (TLX250-CDx) FDA Review – PDUFA August 27, 2025



    • Why it’s big: Zircaix is a first-in-class PET imaging agent targeting clear cell renal cell carcinoma (ccRCC) with strong Phase 3 data (sensitivity 86%, specificity 87%, PPV 93%).

    • Market impact: Targets an underserved $500M+ U.S. market with expansion potential to $750M+.

    • Catalyst: A positive FDA decision in Q3 2025 could immediately validate the platform and significantly expand commercial revenue.





    2.

    TLX101 in Glioblastoma – Pivotal Trial Start in 2025



    • Why it’s big: Potential first systemic radiotherapy that crosses the blood-brain barrier to treat glioblastoma, one of the deadliest and most treatment-resistant cancers.

    • Differentiator: Outpatient IV therapy with promising OS data (32.2 months from initial diagnosis in IPAX-Linz).

    • Catalyst: If pivotal trial data remains consistent, this could redefine GBM therapy and open new market access.





    3.

    TLX591 – Phase 3 in mCRPC (Prostate Cancer)



    • Why it’s big: A novel antibody-based radioligand (rADC) therapy with only two doses vs. 6+ doses for competitors. Strong early OS data (42.3 months).

    • Catalyst: Interim data from Part 1 of the ProstACT Global trial (safety and dosimetry) expected soon. Strong results here could lead to accelerated interest in this asset as an alternative to Novartis’ Pluvicto.





    4.

    Dual PSMA-PET Imaging Strategy – Gozellix + Illuccix



    • Why it’s big: Telix is now the only company with two FDA-approved PSMA-PET imaging agents in the U.S.

    • Market impact: U.S. addressable market growing toward $6.7B annually. Potential for Gozellix to increase access and flexibility in radiopharma scheduling.

    • Catalyst: Continued commercial rollout and adoption of Gozellix may further increase market share and revenue trajectory.





    5.

    Next-Gen Alpha Therapies (TLX592, TLX252)



    • Why it’s big: Alpha-emitting radiopharmaceuticals like TLX592 (225Ac) and TLX252 are designed to overcome resistance in advanced cancers (prostate, CAIX-expressing tumors).

    • Catalyst: Clinical trials expected to start in H2 2025/2026, but investor excitement often front-runs real clinical data due to the scarcity and promise of alpha therapies.





    6.

    Revenue Trajectory



    • Q1 2025 revenue of US$186M (up 62% YoY), with Illuccix alone contributing US$151M.

    • Why it’s big: Telix is not just a speculative biotech — it’s a profitable, growing radiopharma platform with increasing commercial muscle.





    TL;DR — Top 3 Potential Share Price Movers


    Catalyst

    Timing

    Impact Potential

    Zircaix FDA decision

    Aug 2025

    High – New $500M market

    TLX591 interim Ph3 data

    Mid-2025

    High – Differentiated PSMA therapy

    TLX101 pivotal trial start

    H2 2025

    High – First systemic GBM radiotherapy


 
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