Daily Roundup

Thursday, 5th June 2025
Last updated: 20:00

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Maas Group Reaffirms Guidance, Clarity Pharma Announces Positive Trial Results

Maas Group Holdings (MGH) has reaffirmed its FY25 guidance, with the construction materials company expecting Underlying EBITDA in the range of $215 million to $245 million. MGH also reiterated its plans to sell over $100 million worth of assets by FY25, with the proceeds expected to be at or above book value.

In a separate announcement, Clarity Pharmaceuticals shared positive topline results from its DISCO Phase II trial. The company's 64Cu-SARTATE PET imaging agent substantially outperformed the standard-of-care 68Ga-DOTATATE in detecting lesions in neuroendocrine tumor (NET) patients. 64Cu-SARTATE identified 393 to 488 lesions, compared to just 186 to 265 lesions detected by the standard agent. Importantly, 93.5% of the discordant lesions were only picked up by Clarity's product, which also demonstrated very high lesion-level sensitivity of 93.4% to 95.6%. Clarity plans to rapidly progress discussions with the FDA to initiate a registrational Phase III study of 64Cu-SARTATE in NETs.

Elsewhere, Universal Biosensors (UBI) has received a $2.2 million R&D Tax Incentive rebate from the Australian government for the 2024 financial year. The rebate will help support UBI's continued research and development efforts in designing electrochemical cells and point-of-use devices.

Finally, PainChek Ltd has completed a successful final feedback review meeting with the US FDA, paving the way for the submission of additional clinical study data and a final decision on De Novo regulatory clearance within 75 days. The company remains confident it will be able to launch a version of its pain assessment and monitoring application in the US market later this year.

Overall, it's been a busy day for ASX-listed companies, with a mix of reaffirmed guidance, positive clinical trial results, government support, and regulatory progress. As always, investors should do their own research and consult a licensed financial advisor before making any investment decisions.