SAN DIEGO – Three months ago, Acadia Pharmaceuticals Inc. said Nuplazid (pimavanserin), its serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor, met the primary endpoint during an interim look at the phase III Harmony study in patients with dementia-related psychosis (DRP).
In its second large deal of the calendar year, Neurocrine Biosciences Inc. acquired the rights to Xenon Pharmaceutical Inc.’s selective sodium channel inhibitor for treating epileptic encephalopathy. Xenon receives $30 million up front, $20 million in equity and up to $1.7 billion in potential development, regulatory and commercial milestone payments.
Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%.
A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.
A Chinese study has identified small-molecule compounds that can selectively reduce levels of the mutant Huntingtin (HTT) protein involved in the pathogenesis of Huntington's disease (HD), and possibly other neurodegenerative diseases involving mutant protein accumulation.
Good news from San Diego-based Acadia Pharmaceuticals Inc.'s phase III trial with Nuplazid (pimavanserin) in dementia-related psychosis (DRP) had analysts trotting out music metaphors in reports about the study called Harmony, while talking already about would-be sales of the drug, a selective serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor.
Shares of New York-based Neurotrope Inc. (NASDAQ:NTRP) fell 77.3% to close at a record low of $1 Monday after a phase II study of its lead candidate, bryostatin-1, failed to outperform a placebo in helping people with moderate to severe Alzheimer's disease (AD) achieve improvement on a standardized measure of cognition.
DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003.
Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.
Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021.