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Telix (ASX:TLX) has copped a sharp jab on Monday as the FDA says its drug TLX101-CDx, AKA Floretyrosine, can’t be accepted for imaging the rare brain cancer glioma.
In short, the US regulator is asking for more data from Telix with regards to the drug before it allows the company to go ahead with trials.
While this isn’t a high-level death blow for Telix, it does represent a set-back, given that these procedures to pass regulatory hurdles generally take around at least six months.
(Still, at the start of the year, Telix shares clocked YoY gains of +150% – in late April, that read now sits at +81%.)
So what’s the problem? All in all, the FDA wants more information to satisfy itself.
“The FDA stated additional confirmatory clinical evidence is required to progress the application, despite a robust consultation process prior to submission and during review of the [application],” TLX wrote on Monday.
Telix also noted that FDA’s decision was not based on safety, but rather the total volume of background data available to it.
“This is a disappointing outcome for American glioma patients,” Telix continued.
“The FDA has [already] granted TLX101-CDx Orphan Drug and Fast Track designation, a tacit acknowledgement of the drug candidate’s importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.”
But perhaps mitigating the sell-off was Telix chief Dr. Christian Behrenbruch’s suggestion the company may be able to get more data on the FDA’s desk quicker than thought.
“We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studiesWe have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studies,” Behrenbruch said.
“Our immediate focus is understanding the FDA’s feedback.”
Make of that what you will.
TLX last traded at $27.10/sh.
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