June 29 Quick Takes: Disclosure of impropriety jeopardizes integrity of BioXcel’s trial

Although BioXcel Therapeutics Inc. (NASDAQ:BTAI) said the top dose of orally dissolving dexmedetomidine formulation BCXL1501 met the primary endpoint in the Phase III TRANQUILITY II study to treat Alzheimer’s disease agitation, the company’s disclosure that an investigator in the study apparently fabricated email correspondence concerning an adverse event weighed on BioXcel’s shares, which sank 64% on Thursday. The company said the investigator was at a site that included 40% of the subjects enrolled in the study, and acknowledged that the developments jeopardize its plans to seek the therapy’s approval.

Shanghai-based Laekna Inc. (HKEX:2105) climbed 21% to HK$15 on Thursday, its first trading day, after raising HK$790.9 million ($101 million) through the sale of 63.7 million shares at HK$12.41 in an IPO, giving it a post-money valuation of HK$4.8 billion ($618.4 million). The company’s two lead cancer therapies are partnered with Novartis AG (SIX:NOVN; NYSE:NVS); both are in Phase II testing. LAE002 is an AKT inhibitor in development for ovarian, prostate and breast cancer as well as solid tumors resistant to PD-1/PD-L1 inhibitors. LAE001 is a dual inhibitor of CYP17A1 and CYP11B2 for prostate cancer. ...