FINWIRES · TerminalLIVE
FINWIRES

Radiopharm Theranostics to Meet With US FDA on Phase 3 Brain Metastases Diagnosis Trial

By

Radiopharm Theranostics (ASX:RAD) will meet with the US Food and Drug Administration (FDA) on Oct. 1 to seek alignment on the design of a phase 3 trial to evaluate its RAD101 imaging agent in patients with suspected recurrence of brain metastases following radiotherapy, according to a Monday filing with the Australian bourse.

The meeting will focus on the trial's design criteria, including the number of patients to be enrolled and the primary and secondary endpoints, per the filing.

The FDA will also review data from a phase 2b trial of RAD 101, which showed 93% concordance between MRI and PET imaging of brain metastases in the targeted patient population, the company said.

Related Articles

Asia

Sands China's Attributable Profit Slips 3.6% in H1; Interim Dividend Declared

Sands China (HKG:1928) recorded a 3.6% decline in profit attributable to equity holders in the first half to $398 million from $413 million a year prior.Earnings per share slipped to $0.0492 from $0.051 previously, according to a Friday Hong Kong bourse filing.Net revenue increased 11% to $3.88 billion from $3.49 billion in the year-ago period.The company declared an interim dividend of HK$0.50 per share for the period, payable Oct. 9 to shareholders of record as of Sept. 18.

HKG:1928
Asia

Longfor Warns of Lower H1 Profit

Longfor (HKG:0960) expects profit attributable to owners of between 1.8 billion yuan and 2 billion yuan for the six months ended June 30, down from 3.22 billion yuan a year prior.The property developer attributed the forecast to a continued decline in recognized revenue from the property development business and pressure on the recognized gross profit margin.

HKG:0960
Asia

MCC Logs 447.5 Billion Yuan in January-July New Contract Value

Metallurgical Corp. of China (SHA:601618, HKG:1618), or MCC's, newly-signed contract value for the seven months ended July 31 stood at around 447.5 billion yuan.Of the total, the value of newly-signed overseas contracts reached roughly 39.1 billion yuan, according to a Friday Hong Kong bourse filing.

HKG:1618SHA:601618