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.

Rising from Case Western Reserve in Cleveland was science that Roche Holding AG's Genentech Inc. could not pass up, so it struck a deal with Convelo Therapeutics Inc. to discover and develop remyelinating medicines for patients with neurological disorders such as multiple sclerosis.

LONDON – Cytox Ltd. is launching a genetic test that can predict the risk of developing Alzheimer's disease and is able to single out which people presenting with symptoms of mild cognitive decline will go on to most rapidly develop Alzheimer's disease.

Prospects for the new wave of migraine therapies targeting calcitonin gene-related peptide (CGRP) – with three approved already and more in developers' pipelines – have been the topic of talk lately, with analysts such as Evercore ISI's Umer Raffat pointing to what some might see as a dispiriting level-out in sales among those treatments to reach the market so far.

Word from the FDA to Axsome Therapeutics Inc. about the effort with oral N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.

Merck & Co. Inc. has tapped Skyhawk Therapeutics Inc. for its expertise in the discovery and development of small molecules that modulate RNA splicing, agreeing to pay it up to $600 million per program target plus royalties on sales of any commercialized products of the collaboration. The deal, focused on potential treatments for certain neurological diseases and cancer, was accompanied by news of an expansion of Skyhawk's collaboration with Biogen Inc., which originally signed on with the Waltham, Mass-based company in January.

Positive data from one clinical trial evaluating lumateperone in patients with bipolar disorder wasn't enough to lift Intra-Cellular Therapies Inc.'s stock Monday as another trial's failure with the same drug severely dampened the price of shares, while analysts took the long, more optimistic view.

PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).