Clarity Pharmaceuticals (ASX:CU6) has revealed it’s received fast track status from the US FDA for its prostate cancer imaging compound designed for PET scans.
In short, for a PET scan to work, the body needs to be injected with a compound that shows up on the scanner. This is the crash course explanation of how that tech works; not all compounds are equal and some compounds can target some parts of the human body better than others.
In that light, the FDA sees enough merit to Clarity’s product – named ’64Cu-SAR- bisPSMA’ – to give it fast track status to accelerate the approvals process, just in case it turns out the compound can, in fact, show superior performance in imaging prostate cancers over competitor products.
The news is ultimately a win for shareholders – assuming all cards in order and positive results along the way, the regulatory journey through the FDA universe is thus, literally, fast tracked.
The fundamental benefit is a potentially faster path towards commercialisation. Clinical program trials are ongoing.
“Receiving Fast Track Designation for 64Cu-SAR- bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product,” Clarity EC Dr. Alan Taylor said.
“The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic.”
CU6 last traded at $6.62.