A Phase III trial of Axsome Therapeutics’ AXS-05 hit both the primary and secondary endpoints in patients with Alzheimer’s disease agitation, the New York-based company announced Monday.
The company had said this month that Blenrep failed the main goal of a key study designed to show it was better than an existing treatment on the market, stoking fears that regulatory approval could be rescinded by the FDA.
The company said its therapy involving cancer drug Keytruda in combination with chemotherapy met the main goal of a late-stage study for treating a type of gastric cancer.
Astellas’s Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.
After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.
New research out of McMaster University found a recently abandoned Bayer compound halted the growth of an aggressive form of pediatric medulloblastoma in mouse models.
Three Ebola vaccine candidates for a planned clinical trial are expected to be shipped to Uganda next week, World Health Organization Director-General Tedros Adhanom Ghebreyesus said on Wednesday.
When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise – including Biogen and Eisai.
Roche announced its investigational antibody gantenerumab failed to meet the primary endpoints in GRADUATE I and II – two Phase III studies in Alzheimer’s disease.
“We are surprised and disappointed” that the drug did not show superiority over the placebo, Chief Executive Officer John Kollins said.