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Once-Daily Treatment for Hypersomnia, Small Molecule Therapy Receives FDA Approval Again
Avadel Pharmaceuticals Announces FDA Approval of Lumryz sNDA for the Treatment of Cataplexy or Excessive Daytime Sleepiness (EDS) in Patients Aged 7 and Older with Narcolepsy
Lumryz is an extended-release formulation of sodium oxybate taken at bedtime, which was initially approved by the FDA on May 1, 2023, for the treatment of cataplexy or excessive daytime sleepiness in adult patients with narcolepsy. The approval of Lumryz in adults was based on positive results from the Phase 3 clinical trial REST-ON. The study demonstrated that, compared to placebo, Lumryz showed highly statistically significant (p<0.001) and clinically meaningful effects across three co-primary endpoints: Maintenance of Wakefulness Test, Clinical Global Impression of Improvement score, and weekly average number of cataplexy attacks.
Terray Therapeutics, Inc. Secures $120 Million in Financing to Advance Generative AI Pipeline into Clinical Stage
Terray Therapeutics Aims to Improve Human Health by Accelerating the Speed, Reducing Costs, and Increasing Success Rates of Small Molecule Drug Development Through Large-Scale Integration of Computation and Novel Data. Today, the Company Announced the Completion of a $120 Million Series B Financing. This Round of Funding Will Advance Its Internally Developed Pipeline, Based on Generative AI, Into Clinical Trials, and Further Enhance Terray’s Integrated AI Platform, tNova, to Support Both Internal and Collaborative R&D Projects.
Relying on its proprietary experimental platform, Terray Therapeutics has built one of the largest chemical datasets globally. Over the past three years, Terray has quantitatively measured more than 5 billion target-ligand interactions. This dataset grows twofold annually. Terray's data advantage endows it with potential "best-in-class" AI capabilities to identify and optimize novel small molecules that address complex problems. Terray applies this expertise to its internal pipeline focused on immunological diseases while collaborating with Bristol Myers Squibb and Calico to tackle more challenging targets.
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[1] Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy. Retrieved October 17, 2024, from https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-fda-approval-lumryztm-sodium[2] Terray Therapeutics Closes Oversubscribed $120M Series B to Advance Its Generative AI Pipeline of Small Molecule Therapeutics to the Clinic. Retrieved October 17, 2024, from https://www.businesswire.com/news/home/20241017147331/en/Terray-Therapeutics-Closes-Oversubscribed-120M-Series-B-to-Advance-Its-Generative-AI-Pipeline-of-Small-Molecule-Therapeutics-to-the-Clinic
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