6 stories mentioning ASX:CU6Updated 18d ago
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Clarity Pharmaceuticals (ASX:CU6) logged a AU$0.291 loss per share for fiscal 2026, compared with a loss of AU$0.201 a year ago, a Thursday filing showed.For the 12 months ended June 30, revenue from ordinary activities was AU$8 million, which the Australia-listed developer of radiopharmaceutical diagnostics products said was up 68% from a year earlier.
Clarity Pharmaceuticals (ASX:CU6) said two new participants, evaluable at data cut-off in the group expansion phase of the phase I/IIa SECuRE trial in patients with prostate-specific membrane antigen-expressing metastatic castration-resistant prostate cancer at the 8 gigabecquerels of copper-67-SAR-bisPSMA dose level, achieved a complete response, according to a Wednesday Australian bourse filing.Nineteen participants from the SECuRE trial were included in the assessment of the safety and efficacy of the 8 gigabecquerels of copper-67-SAR-bisPSMA dose level, and 81% of the evaluable participants for radiographic assessment at data cut-off achieved disease control, the company said. Across all 19 participants, the median number of treatment cycles of 8 gigabecquerels of copper-67-SAR-bisPSMA was two.The company said 74% of evaluable participants at data cut-off achieved reductions of 25% or over in prostate-specific antigens, 63% achieved reductions of 50% or over, 53% achieved reductions of 75% or over, and 26% achieved reductions of 90% or over.This included three participants from group 2 of the dose escalation phase of the trial, as well as 16 participants from the ongoing group expansion phase.The most common related adverse events were gastrointestinal and hematological disorders, with the majority being mild or moderate and transient, per the filing.The company's shares jumped nearly 14% in recent trading on Wednesday.
Clarity Pharmaceuticals (ASX:CU6) plans to conduct a registrational phase three trial of the copper-64-SARTATE treatment candidate in neuroendocrine tumors, following an end of phase meeting with the US Food and Drug Administration, according to a Friday Australian bourse filing.Trial recruitment remains ongoing in the firm's Clarify phase three registrational trial for copper-64-SAR-bisPSMA as a diagnostic agent in patients with prostate cancer prior to undergoing radical prostatectomy. It is a non-randomized, open-label clinical trial in around 383 participants.The company held a cash position of AU$178.3 million as of June 30, per the filing. It said it holds over 60% of cash reserves in US dollars, adding that the recent appreciation of the Australian dollar resulted in an unrealized exchange loss of AU$5.9 million as of June 30.Clarity Pharmaceuticals' shares jumped nearly 12% in recent trading on Friday.
Clarity Pharmaceuticals (ASX:CU6) will start a registrational phase 3 trial of copper-64-SARTATE in neuroendocrine tumors, following a successful end-of-phase meeting with the US Food and Drug Administration (FDA), according to a Thursday Australian bourse filing.The company plans to recruit around 70 participants for the trial.Clarity is also conducting recruitment for its registrational phase 3 positron emission tomography imaging trial of participants with high-risk prostate cancer prior to radical prostatectomy using copper-64-SAR-bisPSMA in the US and Australia, per the filing. It plans to recruit around 383 participants.The trial will assess the diagnostic performance of copper-64-SAR-bisPSMA positron emission tomography in detecting prostate cancer within the pelvic lymph nodes, the filing said.Clarity Pharmaceuticals' shares fell nearly 2% in recent trading on Thursday.
Australian shares rose on Tuesday's close as investor sentiment was buoyed by optimism around a peace deal between the US and Iran, even as the US naval blockade of Iran took effect.The S&P/ASX 200 Index climbed 0.5% or 44.80 points to close at 8,970.80, reaching a new 20-day high.US President Donald Trump said Iran had called the White House over a potential peace agreement.Both countries had left room for further negotiations, and there was forward motion on trying to get to an agreement, Reuters reported, citing sources.Brent crude oil futures declined 1.5% to $97.90 per barrel.On the domestic front, the Westpac-Melbourne Institute Consumer Sentiment Index fell sharply around 13% to 80.1 in April from 91.6 in March, as rising fuel prices and interest rates added to cost-of-living pressures and weighed heavily on economic sentiment.Business confidence in Australia fell 29 points to negative 29 in March, its lowest level since April 2020 and one of the sharpest declines since the global financial crisis and COVID-19, following the Middle East conflict, National Australia Bank said in a report.Australia's consumer confidence lifted 2.2 points in the April 6 to April 12 week to 64.5 points, recording its second consecutive weekly rise, while the four-week moving average fell 1 point to 62.2 points, ANZ said in a report.In company news, Qantas Airways (ASX:QAN) now expects fuel cost for the fiscal second half to be AU$3.1 billion to AU$3.3 billion, as February jet refining margins peaked at about $120 per barrel. The airline said it has hedged about 90% of its fiscal H2 crude oil exposure but remains largely exposed to movements in jet refining margins.Cleanaway Waste Management (ASX:CWY) now expects fiscal 2026 earnings before interest and taxes of AU$460 million to AU$480 million, down from a previous range of AU$480 million to AU$500 million, due to the impact of the Middle East conflict. Its shares declined 2% at close.Lastly, Clarity Pharmaceuticals (ASX:CU6) signed a commercial manufacturing agreement for its copper-64 SAR-bisPSMA next-generation diagnostic imaging agent with Nucleus Radiopharma. The agreement includes manufacturing at Nucleus Radiopharma's facility in Rochester, Minnesota. Clarity's shares closed down 5%.
Clarity Pharmaceuticals (ASX:CU6) signed a commercial manufacturing agreement for its Cu-64 SAR-bisPSMA next-generation diagnostic imaging agent with Nucleus Radiopharma, according to a Tuesday filing with the Australian bourse.The agreement includes manufacturing at Nucleus Radiopharma's facility in Rochester, Minnesota, which has a production capacity of around 50,000 patient doses per year, as well as future production at a Spring House, Pennsylvania, facility planned to open in 2028 with a capacity of up to 600,000 doses per year.The two facilities will service key commercial markets, with distribution to all 50 US states and some international locations including Europe, per the filing.Clarity Pharmaceuticals plans to commercially launch the new diagnostic imaging agent after completing phase 3 registrational trials and obtaining new drug application approval from the US Food and Drug Administration.
