Forum Topics TLX TLX Resubmits NDA / FDA Pixclara B

Pinned straw:

Added a month ago

Telix Resubmits NDA to FDA for Pixclara Brain Cancer Imaging

What, and How long this will take 1month 2 month!

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Dr. David N. Cade, Telix Group Chief Medical Officer, said, “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.” Maggie Haynes, Executive Director, Head for the Cure Foundation, added: “Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.” 

Chart looks ok .. a break out here to get on


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mikebrisy
Added a month ago

@raymon68 given that addressing the CRL required additional data and/or analysis, this almost certainly makes the resubmission a Class-2 resubmission. The standard timeline for that is a 6-month review clock. Having Orphan and Fast Track status does not necessarily change that clock. Nor has there been any information to indicate that Pixclara will receive Priority Review.

How, having said that, it is entirely possible that the FDA do reach a decision earlier. It possibly comes down to how material the new information is to the decision as well as how important the FDA considers approving this new first-in-class drug.

So, my base case expectation is that the timeline here is 6-months, even though I believe there is some commentary in the market that it could be fast (e.g. Head for the Cure Foundation being "hopeful of an expedited review".) A positive earlier decsion would be a positive surprise.

On chances of success, on a statistical basis, Class 2 resubmissions have a 70% - 75% chance of success. (Generically, the pass rate is 60% - 75%, but with an imaging agent, we should be at the upper end of that.). This is lower than the initial NDA pass rate at the final hurdle. Basically, if you don't clear the hurdle at the first jump, your chances of clearing at a subsequent attempt are diminished. Of course, that's an industry average, generic kind of assumption. Who knows where Pixclara stands.

Disc: Held

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Foxlowe
Added a month ago

Good context in here already by @raymon68 and @mikebrisy  , so I’ll just add the bit I think matters.

TLX isn’t a one‑shot biotech swinging for the fences — they’re already doing US$800m revenue and have a proper commercial engine behind them. Pixclara is important, but it’s not the whole show.

On the resubmission: Class‑2 usually means a 6‑month clock, so September is the base case. Fast Track and Orphan don’t magically speed that up, but they do keep the FDA talking, which is half the battle.

From a market behaviour point of view, these things tend to drift for a while and only tighten up in the last month or so before a decision. That’s usually when sentiment and the actual approval odds (70–75% for Class‑2) start to diverge.

So for me it’s a ‘track it’ situation rather than a ‘rush in’ one. The real window is closer to the decision, not now


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mikebrisy
Added a month ago

@Foxlowe agree that there is a hell of a lot more to $TLX than Pixclara. (I think I posted their 2026 catalysts chart after 1H FY26.)

Shares have been beaten down following: Illuccix maturing and pricing pressure; slower Illuccix rollout beyond US than market was expecting; Gosellix yet to contribute materially; setbacks for both Pixclara and Zircaix (but both still in the game); theranostics still perceived as speculative (they are).

So, my point is, there is a lot of bad news in the SP now. While normally SP drifts and short selling dominates the price action until last month or two before a major milestone, there are so many moving parts for $TLX that I’m not sure that applies. As you rightly say, Pixclara is just one element. But it is true that the short position is large, and shorts seem to be betting that across the board $TLX is going to underperform.

I’ve placed my bets and happy to take a 3-5 year view. I could not have foreseen the bad news that has unfolded in the last 12 months. It could very easily have gone the other way. So I am happy to be patient.


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Foxlowe
Added a month ago

Great summary @mikebrisy I agree the last 12 months have thrown a lot at TLX, and most of it is already sitting in the price.

From my side, I still think the regulatory cadence matters. A Class‑2 resubmission typically runs on a 6‑month clock, which puts the base‑case decision around September. The final 4–6 weeks before that window is usually where sentiment and positioning start to diverge from the fundamentals — even when the company has multiple moving parts like TLX does.

Pixclara isn’t the whole story, but it’s still a meaningful catalyst in a business that already has scale, revenue and a pipeline. Shorts can dominate the drift phase, but they don’t get to dominate the decision phase.

I’m taking a similar multi‑year view, but I think the timing structure still matters.

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mikebrisy
Added a month ago

@Foxlowe For sure, it’s just a matter of degree, per your first post.

I have the unrisked success case for Pixclara worth $3-$4 ($2-$3 risked, today) but of course, success will blow a positive sentiment back into the stock more generally, which on its own, could add as much again or more into it while it lasts.

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