Telix Pharmaceuticals Limited

ASX:TLX

Telix Pharmaceuticals Limited

ASX:TLX
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$14.81 (+1.7%)
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#20
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40
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Pinned straw:
mikebrisy
Added 7 months ago

FDA has not approved the NDA for Pixclara for imaging glioma.

Looks like grounds are efficacy. $TLX will try to arrange a meeting to understand the basis for the rejection.

Obviously bad news. But not a thesis breaker, as $TLX has many irons in the fire.

For any who need a reminder, these milestones are often binary events!

We’ll need to wait the readout from any FDA meeting, but given the timescales, even if they progress with gathering more evidence, the timeline is pushed out a year or two in the success case, as this is pretty fundamental.

Only 30-40% of drugs go on to receive approval after receiving a CRL rejection from the FDA.

TAM for Pixclara is quite small, so I’ll be keeping an eye out for any market over reaction.

Disc: Held in RL and SM
topowl
Added 7 months ago

Great example.

Sometimes the FDA does rejects things.

Even with established companies like Telix.


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lowway
Added 7 months ago

So I'll admit to being quite conflicted when it comes to $TLX @mikebrisy & @topowl. I do like the strategy and possible treatment products (yet to be approved of course) for kidney, prostate & brain and I believe the current missed approval was overreacted to by shareholders (so my time to buy as I had been watching an entry price for some time). The conflicted comes from personal experience and use of their isotope solution using Gallium 68 for my own PSMA PET Scan at iMed. Unfortunately, it was a failure in my case and the best summary stated inconclusive!!

On the other hand, another PSMA PET solution using F18 DCFPyL via Qscan worked great when recently undertaken before my prostatectomy.

I'll put it down to "horses for courses" (I think the stats say approx 15% have no postive reaction to Gallium 68 type solutions, or so my Urologist said) as I do like the $TLX story, so hopefully I don't get to trial any more of their products, but if I do, that they actually work for me!!

That said, my Urologist was pretty sure Qscan would get an outcome, which they did, but also to be fair to iMed and Gallium 68, Qscan knew that solution did not work, so they went with the more onerous 2.5 injection of F18 and got the desired result.

Anyway, still bought $TLX in SM portfolio, but will continue to watch closely as a shareholder, not a patient!!

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