Telix Pharmaceuticals (TLX-AU)

Ventures in biotech!!?

There is a big fat disclaimer at the rear of this post - read it. This is not financial advice, and is merely my honest and genuine analysis on the securities discussed.

SP: $14, M/C: ~A$4.7bn, ADV: ~A$14m/day

Telix has been under pressure lately.

August 2025. Telix receives a Complete Response Letter (‘CRL’) relating to it’s Biologics License Application (‘BLA’) for TLX250-CDx.

The CRL relates to comparability between the drug used in clinical trials and that being made in commercial manufacturing.

The find also triggered ‘483’s in third-party manufacturing.

This roughly translates to the FDA finding issues with the drug Telix has trialled and that to which they intend to commercially manufacture. Ala, there are issues in Telix’ supply-chain.

Is the manufacturer really a third party?

On the left are site locations for TLX250-CDx trials. The Australian locatons overlap with facilities of radiopharm company Cyclotek

Cyclotek have been fined prior for “unacceptable manufacturing practices”

Former Telix CFO Doug Cubbin is a director at Cyclotek. He worked at Telix when the cyclotek/Telix agreement was announced and this was not disclosed.

Cyclotek also appear as a top20 shareholder in Telix at the time of their 2017 IPO.

We have an undisclosed relationship manufacturer that has previously been fined for manufacturing issues and now complicit in TLX250-CDx being rejected.

This isn’t the first time TLX250 was rejected either.

Now the market waits to see if the SEC subpoena into TLX591 trial disclosures goes anywhere.

P.S the Feburary share sale by the CEO looks a timely trade right now.

Disclaimer:
The information contained in this post is for informational and entertainment purposes only and should not be construed as financial, investment, or other professional advice. I may hold or trade positions in the securities discussed, and such positions may change at any time without notice. All opinions expressed are solely my own, based on publicly available information, and do not constitute a recommendation to buy, sell, or hold any security.