Clarity jumps as FDA awards fast track status for PET scan imaging agent

Clarity Pharmaceuticals (ASX:CU6) has seen the U.S. FDA fast-track its prostate cancer imaging compound for use in PET scans on patients with recurring prostate cancer.

The stock jumped 4% in the first hour of trade to $4.23 in what is likely a welcome move for shareholders who have already seen the company’s price climb to as much as $8/sh over the last six months.

Clarity’s market cap currently sits above $1 billion, seeing it join a class of companies on the ASX in biotech undergoing something of a boom.

Just look at Mesoblast, and far more recently, Orthocell as well.

While Clarity’s announcement it’s received fast-track status from the FDA for its copper-based Cu-64 SAR-bisPSMA imaging agent doesn’t reflect a full approval for use in the U.S., it does underscore regulator interest in the agent.

For the uninitiated, the compound is injected into the body such that PET scan machines can then image organs in the body due to small amounts of radiation.

This isn’t the first fast-track status the FDA has given Clarity; in its own words, the permits allow development focusing on prostate cancer patients.

“This milestone builds on Clarity’s earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy,” the company wrote on Friday.

“These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product.”

CU6 last traded at $4.23/sh.

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