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TLX - Telix Pharmaceuticals

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pushed through $30

Telix Pharmaceuticals has forecast full-year 2025 revenue of $1.18bn to $1.23bn, driven by strong sales of its prostate cancer imaging agent.
 
finicky said:
@Miner, don't know mate. All I know with certainty is .. it's getting closer, haha.
This one may never get cheap enough.
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@finicky
Looks like your predicted crash happened today and more on Monday
On December 1, it was around $24, and today, it shot up to $30.
It is always a challenging game. I bought it for $2 and sold it for $6 or so (I have to check the dates and transactions), thinking, OMG, it was too much. I would have retired by holding it just a bit more. We can look back and find our sure-win Lotto numbers but never pick up the actual numbers before the game.
This report highlights some real game changers through Phase 2 and 3 in 2025. I am guessing and not believing myself that 2025 will raise the bar for TLX to a higher level


 
Last edited:
the recent update ...
Q2 2025 Highlights
• Q2 2025 unaudited group revenue of approximately $204 million, up 63% year-over-year.
• FY 2025 revenue guidance of $770 million to $800 million is reaffirmed.
• Gozellix® launched in the U.S. and commercial dose deliveries commenced.
• Gozellix has been assigned a Level II HCPCS code (effective 1 October 2025), a prerequisite for receiving Transitional Pass-Through payment status.
• ProstACT™ Global Phase 3 trial milestone – all 30 patients consented for Part 1. Global expansion with regulatory approvals to expand the trial into China, Japan and Canada.

... may have given early money a chance; & results were met with a rush to the exits.


a recent investor, AFI, may continue to be circumspect ... from their annual report:
...The range of potential outcomes is widely dispersed, accordingly we elected to establish a small holding looking to increase our weighting should our conviction grow.
Click to expand...
 
and below $17
........ a reveal the beancounters don't like?!

Telix Provides Historical Financial Information in USD and Operating Expenditure for H1 2025 (Unaudited)​
 
Dona Ferentes said:
and below $17
........
Click to expand...
whoops ... down 20+ percent ... as low as sub $14

Telix has received a Complete Response Letter from the United States Food and Drug Administration for the Biologics License Application (BLA) for TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls package. The FDA has requested additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally, the FDA has documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission.

Telix believes these concerns are readily addressable and submission remediation will begin immediately. The Company will request a Type A meeting with the FDA as soon as practicable to address the deficiencies and determine an appropriate timeframe for resubmission. TLX250-CDx has a Breakthrough Therapy designation and Priority Review status, acknowledging its importance in addressing a significant unmet medical need and clinically demonstrating benefit over available diagnostics.

Dr. Christian Behrenbruch, Managing Director and Group CEO, said, “TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope. Like many radiopharmaceuticals, it has a complex supply chain, and as the field advances this creates new challenges around the regulatory framework applied to these products. We believe the outstanding matters are resolvable and that we can address the remaining FDA requests within a reasonable time frame.”

The CRL does not impact Telix’s stated revenue guidance for 2025, as guidance excludes revenue forecasts from unapproved products. The Company intends to continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program, subject to consultation with the FDA.
 
TLX @ $14.95

Telix Pharmaceuticals (TLX) -18.75% hit yet another regulatory hurdle as the FDA flagged packaging issues with its Zircaix product.

Not Held
 
3 solid step downs in 2 months with a faltering share price for quite some time before that.
Watching for a convincing turn around on this one.

 
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