ASX Health Stocks: Clarity's prostate cancer imaging agent gets FDA 'Fast Track' status

Clarity’s prostate cancer imaging agent gets FDA Fast Track status
Next Science drops revenue guidance for FY24
Next Science’s share price falls 10% after the news

Clarity’s 64Cu-SAR-bisPSMA gets FDA Fast Track

Clarity 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.

“We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis.”

The product’s dual-targeting structure and longer half-life offer advantages over existing diagnostics, such as better tumour uptake and longer shelf-life, which could improve accuracy and accessibility in prostate cancer management.

Next Science to skip revenue guidance this year

Meanwhile, Next Science Limited (ASX:NXS) has revised its FY24 guidance.

The company, known for its XBIO suite aimed at reducing biofilm-based infections, has faced delays with its new sales strategy and will no longer provide revenue forecasts for the year.

Despite this, Next Science anticipates achieving cash flow positivity in Q4 of FY24 or Q1 of FY25, and expects to be EBITDA positive on an adjusted basis during the same period.

“The sales reorganisation will enable us to drive efficiencies from the top down, maximise the revenue potential within our existing customer base, and access new opportunities,” said Next Science CEO, I.V. Hall.

Hall also pointed out that the company expects future growth due to better revenue and a new flexible cost structure.

The updated strategy is designed to simplify operations and boost revenue, and there’s a US$5 million loan available for extra funds if needed.

NXS’s share price dropped 10% on the news this morning.