Neurosense Therapeutics Ltd. failed to impress Wall Street with top-line data from its phase IIb study called Paradigm with PrimeC, a fixed-dose combination of ciprofloxacin and celecoxib, in amyotrophic lateral sclerosis.

Clinical data disappointments and third-quarte results cast a shadow on the BioWorld Neurological Diseases Index, closing November with an 18.37% year-to-date decline. This marks a slight improvement from its low point in October, down 23.79%, in contrast to the previous year’s upward trend, which it concluded with an 18.24% increase.

The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures  to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.

For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc., which saw its shares (NASDAQ:BIVI) tumble $3.03, or 60%, to end Nov. 29 at $1.96 on missed-endpoint data from the phase III trial testing Alzheimer’s disease prospect NE-3107. The data fell short of statistical significance due to site exclusions caused by what Biovie said were “significant good clinical practice violations and protocol deviations.”

Xenon Pharmaceuticals Inc.’s Kv7 potassium channel opener XEN-1101 remains very much alive despite the primary endpoint miss in top-line data from the phase II proof-of-concept X-Nova trial in moderate to severe major depressive disorder.

Bioxodes SA has set the stage for the phase IIa study of its novel anticoagulant in the treatment of intracerebral hemorrhage (ICH), after raising a €12 million (US$13 million) series A. Days before announcing the closure of the round, the first patient in the proof-of-concept study was treated, on Nov. 17, and eight of 10 sites across Belgium are geared up to take part in the trial. The aim is to develop the product, Ir-CPI, as the first injectable antithrombotic that is suitable for use within the first 72 hours of an ICH.

The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.

In a global deal worth up to $770.5 million in up-front and milestone payments, Stevenage, U.K.-based Autifony Therapeutics Ltd. signed with Dublin-based Jazz Pharmaceuticals plc for two ion channel-targeting programs aimed at finding and developing new drugs for neurological disorders. Autifony will take selected candidates through preclinical development, while Jazz will cover clinical development, manufacturing, regulatory activities and commercialization.

The gene for Huntington’s disease “was cloned in 1993, and everyone thought there was going to be a treatment right around the corner,” Sarah Tabrizi told the audience at the 2023 Annual Meeting of the Society for Neuroscience. Then, “it took 25 years for the first trial targeting the Huntington gene.”