Clarity’s 64Cu-SAR-bisPSMA gets FDA Fast TrackClarity...

Clarity’s 64Cu-SAR-bisPSMA gets FDA Fast TrackClarity Pharmaceutical (ASX:CU6) has been granted FDA ‘Fast Track’ designation for its 64Cu-SAR-bisPSMA, a new imaging agent designed for detecting prostate cancer.
This designation will speed up the development and regulatory review process for the drug, allowing Clarity to submit parts of its application as they are completed and to communicate more frequently with the FDA.
The expedited process could shorten the time needed to bring the diagnostic tool to market.The 64Cu-SAR-bisPSMA has shown promising results in previous studies, including the Phase I PROPELLER study, which demonstrated favourable safety and efficacy.
Clarity has already started a registrational Phase III trial (CLARIFY) and is planning a second Phase III trial based on positive findings from earlier research
.“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,” said Clarity’s Executive Chairperson, Dr Alan Taylor.