Telix (ASX:TLX) has experienced a jolt in its recovery following its July 22 quarterly that saw prices sink – now, the FDA has knocked back an investigational PET scan agent Telix submitted, lengthening out that product’s path to sales. Perhaps of most interest is the news does not impact Telix’s 2025 guidance.
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But with year-to-date performance down -25% as at market open today, it’s probably not the best year in memory for the company’s longer-term shareholders – despite the stock being a bullish pick among brokers. According to Market Index data, nobody is rating it either ‘hold’ or ‘sell.’
So what went wrong with this latest submission?
Having lodged the documents for its product TLX250-CDx, or Zr-DFO-girentuximab if you like, the FDA has come back to the company with the unfortunate news that Telix hasn’t provided adequate information around key manufacturing and chemistry information, along with “notices of deficiency issued to two third-party manufacturing and supply chain partners that will require remediation.”
“The FDA has requested additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial,” Telix wrote on Thursday, adding it “believes these concerns are readily addressable and submission remediation will begin immediately.”
Telix’s relationship with the U.S. regulatory landscape has been a little interesting lately, one could say. In July, the company’s share price sank after the U.S. share trading regulator hit the company with a subpoena over allegations it had misled investors on claims around its cancer drugs; in April, the FDA rejected another drug of Telix’s at a stage in the approvals chain after having earlier approved it.
TLX last traded at $18.40/sh heading into Thursday morning.
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