Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
As expected, weight mitigation and opioid-related risks turned up as the main concerns in briefing documents for the joint advisory panel meeting Oct. 9 to mull the approvability of Alkermes plc’s ALKS-3831.
HONG KONG – Shanghai-based Bioshin Ltd., the Asia-Pacific arm of New Haven, Conn.-based Biohaven Pharmaceutical Holding Co. Ltd., has added $60 million to its war chest via a series A investment.
In the past 10 years, the advances in understanding the etiology of neurodegenerative diseases have been dramatic. “The development of novel biomarkers and other tools as well are key in aiding diagnostic potential and the ability to track disease progression have been phenomenal,” Isaac Veinbergs, CEO of newly created Libra Therapeutics Inc., told BioWorld.
DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease.
Shares of Vaccinex Inc. fell to an all-time low on Sept. 22 after top-line results of the phase II trial, Signal, found its SEMA4D inhibitor, pepinemab, failed to improve measures of cognition in people with early manifest Huntington's disease following 18 months of treatment.
Shares of Marinus Pharmaceuticals Inc. climbed 51.7% to close at $3.20 on Sept. 15 following news that the company's sole clinical asset, ganaxolone, met the primary endpoint of its phase III Marigold study in CDKL5 deficiency disorder, a rare genetic condition that can leave children unable to walk, talk or feed themselves.
A new analysis of biomarkers, superseding confusing results released in May, appears to have re-ignited enthusiasm for the experimental Alzheimer’s disease (AD) candidate, sumifilam, the lead development candidate at Texas-based Cassava Sciences Inc.
Click Therapeutics Inc. and Boehringer Ingelheim GmbH inked a deal valued at more than $500 million to collaborate on the development and commercialization of a prescription-based digital therapeutic for schizophrenia. The mobile application, currently called CT-155, uses cognitive and neurobehavioral techniques to reduce the symptoms of schizophrenia, such as cognitive deficits and impaired social functioning.
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