Lipocine shares tumble (again) after the FDA shows another testosterone therapy the door
Another testosterone therapy is getting the heave ho at the FDA.
Lipocine $LPCN reported this morning that the agency has issued a complete response letter rejecting Tlando as a new therapy for hypogonadism. The biotech spelled out what the FDA says is lacking in the application, and plans to follow up with a sit-down to define a path back to a new pitch.
Shares of the biotech tumbled 15%.
The FDA has significantly raised the bar on testosterone replacement treatments, unhappy with the way they’ve been widely used by a graying generation of men — despite some health risks.
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