In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.

Voyager Therapeutics Inc. has expanded its Alzheimer’s disease (AD) pipeline with the addition of a wholly owned program that modulates the expression of apolipoprotein E (APOE). Using a proprietary intravenous-delivered, blood-brain barrier (BBB)-penetrant Tracer capsid, the product delivers a bifunctional payload.

The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.

Illimis Therapeutics Inc. raised ₩58 billion (US$42 million) in a series B financing round. The funds will support development of ILM-01, its lead bispecific fusion protein candidate, into preclinical development for Alzheimer’s disease by the second half of 2025, along with the company’s neuroimmunology portfolio.

Acumen Pharmaceuticals Inc. and JCR Pharmaceuticals Co. Ltd. have entered a collaboration, option and license agreement to develop a novel therapeutic candidate for the treatment of Alzheimer’s disease (AD).