ASX Health Stocks: Clarity to expand Phase 3 trial sites; CSL downgrades profit on FX headwinds

• Clarity Pharma signs supply deal to expand Phase 3 clinical trials
• Atomo Diagnostics sells HIV test kits in Europe
• CSL says it faces currency headwinds

Clarity Pharma (ASX:CU6) has entered into a supply agreement covering its 64Cu SAR-bisPSMA, a diagnostic radiopharmaceutical product for prostate cancer imaging.

Under the deal, PETNET Solutions will manufacture ready-to-use 64Cu SAR-bisPSMA according to the current Good Manufacturing Practice (cGMP) guidelines for Clarity’s US-based clinical trials.

Specifically, PETNET’s supply of 64Cu SAR-bisPSMA will allow Clarity’s two standalone diagnostic Phase 3 clinical trials to proceed at a large number of clinical sites across the US.

This will enable centralised manufacture and supply for both planned Phase 3 trials from just one facility.

Clarity is anticipated to be entering a pivotal Phase 3 trial in the US before the end of 2023 and, potentially, a second Phase 3 trial in 2024.

The prostate cancer market is one of the largest in oncology, and the company says the growing US market for PSMA PET diagnostics is anticipated to generate sales of US$1 billion during 2023.

Atomo to sell HIV test kits in Europe

Atomo Diagnostics (ASX:AT1) has entered into an exclusive supply deal with UK-based Newfoundland Diagnostics for HIV rapid testing in Europe.

This agreement follows an initial purchase order of HIV Self-Tests worth approximately $900k received from Newfoundland in February.

The agreement today will see Newfoundland commit to placing a larger follow-on order worth approximately $1.2m prior to December 31, which, added to the initial order, secures exclusivity for 2024.

Newfoundland is an emerging company in the growing European diagnostic consumer-initiated testing market that has arisen out of the COVID pandemic.

The company has established extensive distribution networks in Europe, including recent contracts with leading retailers Tesco and Boots in the UK.

CSL downgrades profit on currency headwinds

Meanwhile, Australia’s biggest healthcare company CSL (ASX:CSL) dropped 7% this morning after releasing a market update.

CSL said foreign currency movements will impact the company’s FY23 forecast profit.

CSL now expects a negative foreign currency impact of around US$230 million to $250 million, up from US$175 million anticipated at the time of the half year result.

Constant currency profit guidance for FY231 remains unchanged, albeit now skewed to the top end of the range.

CSL also notes the broad range of published analyst profit projections for FY24.

Following finalisation of next year’s budget, CSL said that NPATA is expected to grow between 13–18% to US$2.9-$3 billion at constant currency.

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