Neurocrine Biosciences Inc. shares (NASDAQ:NBIX) were trading at $123.02, down $29.54, or 19%, after the San Diego-based firm disclosed top-line data from the phase II study with NBI-1117568 (NBI-'568) in adults with schizophrenia. The first investigational, oral, muscarinic M4 selective agonist in development for the condition, NBI-‘568 in the dose-finding study met the primary endpoint at the once-daily 20-mg level. Specifically, the drug demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale total score at week six with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline. The same dose turned up a statistically significant improvement for additional endpoints, including improvement in the Clinical Global Impression of Severity scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change.

Bringing it all back home: Lindy and Novartis cut a nearly $1B deal

Novartis Pharma AG continues to cut some of the biggest collaboration deals of the year through a new agreement with privately held subsidiary Lindy Biosciences Inc. The two plan to create self-administered injections for some Novartis medicines that are currently infused intravenously. Lindy is getting $20 million up front and could bring in as much as $934 million in milestones and net sales. In July, Novartis Pharma, a subsidiary of Novartis AG, and privately held Dren Bio Inc. inked a $3 billion agreement to develop bispecific antibodies for cancer. Novartis and Shanghai Argo Biopharmaceutical Co. Ltd. agreed in January to develop cardiovascular disease programs. The deal is worth about $4.2 billion. In May, Novartis Pharma and Peptidream Inc. agreed to identify and optimize macrocyclic peptides. Peptidream could bring in $2.89 billion.

Telix submits NDA to FDA for radiopharma brain imaging agent

Telix Pharmaceuticals Ltd. filed an NDA with the U.S. FDA for its radiopharmaceutical glioma imaging product, TLX-101-CDx (Pixclara, 18F-floretyrosine, 18F-FET), for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. The U.S. FDA granted fast track designation to TLX-101-CDx for glioma imaging and orphan drug designation as an imaging agent for managing glioma. TLX-101-CDx targets L-type amino acid transporters 1 (LAT1) and LAT2, enabling it to be used as a “companion” theranostic imaging agent for TLX-101, Telix’s investigational neuro-oncology candidate, which targets the same amino acid transporter mechanism with therapeutic targeted radiation, currently in a phase II trial.

Yunovia cleared for Korea phase I trial of small-molecule GLP-1 asset

Yunovia Co. Ltd. gained clearance in South Korea to start a multiple ascending dose (MAD) phase I study for ID-110521156 – a novel, orally available, small-molecule, glucagon-like peptide-1 (GLP-1) agonist. Hwaseong-si, South Korea-based Yunovia said Aug. 27 that the Ministry of Food and Drug Safety cleared its IND application for the MAD trial, following successful completion of a phase I single ascending dose (SAD) study that included a food effect study in July 2024. Yunovia is a subsidiary split from Seoul-based Ildong Pharmaceutical Group in October 2023, inheriting all R&D assets from the parent firm. Results of the phase I SAD trial of the GLP-1 candidate showed ID-110521156 was well-tolerated and demonstrated potential as a once-daily drug with a sustained pharmacokinetic profile, according to the company.

Glial glucose restoration rescues cognition in Alzheimer’s disease

Restoring glucose metabolism in astrocytes, which is impaired in Alzheimer’s disease, has a direct effect on neurons, which replenish their fuel supply and resume synaptic activity. A group of scientists from Stanford University School of Medicine has revealed the pathway that explains where this efflux is interrupted and which molecules restore it in mouse models with amyloid and tau pathology. Their findings could help prevent the progression of this neurodegenerative disease. “The presence of this pathway in astrocytes was very intriguing. So, we wondered what it could be doing. And we found that this pathway is induced when you have amyloid or tau,” senior author Katrin Andreasson, a professor of neurology and neurological sciences at Stanford Medicine, told BioWorld.

Also in the news

Addex, Agile, Arca, Avanzanite, Basilea, Bavarian Nordic, Bioarctic, Biovie, Camp4, Clearpoint Neuro, Eli Lilly, Elite, Harvard Apparatus Regenerative Technology, Humacyte, Indivior, Insud, Invivyd, Janssen, JW, Lexaria, Navigator Medicines, Oruka, Roche, Soleno, Spago, Structure, Vaderis, Yoltech, Zyus