Telix Pharmaceuticals Expected to Present Data from First Part of Phase Three Study to Seek Investigational New Drug Amendment, Jefferies Says

MT Newswires Live
Mar 10

Telix Pharmaceuticals (ASX:TLX) is expected to present data from the first part of its ProstACT Global phase three study to the US Food and Drug Administration (FDA) to seek an Investigational New Drug amendment to progress the second part in the US, which is expected to be granted, according to a Tuesday note by Jefferies.

Telix said the first part of its ProstACT Global phase three study achieved its primary objectives, confirming the safety profile, biodistribution, and dosimetry of the drug candidate TLX591-Tx, or lutetium-177 rosopatamab tetraxetan in combination with one of three standard of care therapies, abiraterone, enzalutamide, or docetaxel.

Grade 3 and 4 thrombocytopenia across the three groups in the study was 45%, with rapid thrombocytopenia recovery in the docetaxel group by day 50.

The investment firm retained its buy rating and its AU$23.40 per share price target.

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