Two phase III failures with Roche Holding AG subsidiary Genentech Inc.’s gantenerumab in staving off mild cognitive impairment tied to Alzheimer’s disease (AD) revealed the level of amyloid-beta removal was lower than the company expected. The protein amyloid beta accumulates in the brains of AD patients and its removal is suspected to be an eventual boon to AD patients. But there are still plenty of doubts. Top-line results from Genentech’s phase III Graduate I and II studies show gantenerumab, a fully human monoclonal IgG1 antibody, missed the primary endpoints of slowing clinical decline in those with mild cognitive impairment due to AD and mild AD dementia.
Minoryx Therapeutics SL is banking what it described as “a significant double-digit up-front payment” and could earn up to €258 million (US$262.1 million) more in milestone payments and development funding from a license agreement with Neuraxpharm GmbH, which covers European rights to its lead drug candidate, leriglitazone, in central nervous system indications. It will also receive tiered double-digit royalties on product sales.
NRG Therapeutics Ltd. has closed a £16 million (US$18.3 million) series A round to take forward programs in Parkinson’s disease and amyotrophic lateral sclerosis, after pinning down the target of its brain penetrant small molecules.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.
Sensorium Therapeutics Inc. closed a $30 million series A round to fund the discovery and development of new psychiatric drugs, inspired by human ethnobotanical practices that date back hundreds or even thousands of years.
Once pharma’s great hope to replace opioid painkillers, it looks like the end for nerve growth factor (NGF) inhibitors after Regeneron Pharmaceuticals Inc. quietly axed fasinumab, the late-stage painkilling injection it was developing in partnership with Teva Pharmaceuticals Ltd. and Mitsubishi Tanabe Pharma Corp.
By pairing the expression of an inhibitory ion channel with an activity-dependent promoter, researchers have developed the first on-demand gene therapy that specifically silenced hyperactive cells and prevented epileptic seizures.
Compass Pathways plc is poised to start the first ever phase III trial of the psychedelic drug psilocybin, after getting U.S. FDA backing for a study in treatment-resistant depression.
Emalex Biosciences Inc. closed an upsized and oversubscribed $250 million series D funding round intended to support a soon-to-start phase III trial and preparations for potential commercialization of ecopipam, its first-in-class drug for Tourette syndrome, a neurological disorder characterized by involuntary motor and vocal tics.
Alkermes plc’s decision to explore separating its commercial-stage neuroscience business from earlier-stage oncology efforts – forming a distinct, publicly traded company to investigate cancer therapies – drove speculation about the launch of the firm’s Lybalvi (olanzapine and samidorphan), approved by the U.S. FDA in the middle of 2021 for schizophrenia and bipolar I disorder.