JAZZ PHARMACEUTICALS FRANCE

Avadel Pharmaceuticals reports $50 million in LUMRYZ revenue, 2,300 patients on the drug, and FDA approval for pediatric use. The company also secured a court ruling affirming LUMRYZ's clinical superiority over twice-nightly oxybates and is progressing its Phase 3 REVITALYZ study.

AstraZeneca and Amgen's Tezspire showed efficacy in reducing nasal congestion and nasal polyps in a Phase 3 trial for chronic rhinosinusitis. Jazz Pharmaceuticals plans to start an early-stage study for narcolepsy treatment JZP441 in 2024. Geron secured $250 million, potentially $375 million, for its myelofibrosis drug Rytelo. Aditum Bio and Leads Biolabs formed Oblenio Bio to develop a T cell engager for autoimmune diseases. Gilead Sciences halted Trodelvy development in second-line non-small cell lung cancer, resulting in a $1.8 billion write-down. Avid Bioservices is being taken private by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion deal.

ALX Oncology's Q3 2023 Form 10-Q reports financial improvements, ongoing evorpacept trials, strategic initiatives, and challenges in advancing its CD47 checkpoint pathway therapies.

Seltorexant, a potent, selective orexin-2 receptor antagonist, improved symptoms of major depressive disorder (MDD) and insomnia in a phase III trial. The study drug, when combined with current antidepressant treatment, showed a significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo. Seltorexant is unique as it targets only OX2 receptors, potentially filling an unmet need for new therapies for MDD and insomnia.

ALX Oncology's Phase 1b/2 trial results of evorpacept combined with zanidatamab in HER2-positive and HER2-low metastatic breast cancer accepted for poster spotlight at SABCS 2024, to be presented by Alberto J. Montero on Dec. 12.

US court upholds FDA approval of Avadel Pharmaceuticals' Lumryz, a once-nightly oxybate for narcolepsy, rejecting Jazz Pharmaceuticals' challenge on orphan status and clinical superiority grounds. Lumryz retains orphan drug exclusivity and is deemed clinically superior to existing treatments.

ALX Oncology's Phase 1b/2 trial results of evorpacept combined with zanidatamab for HER2-positive and HER2-low metastatic breast cancer accepted for poster spotlight at SABCS, Dec 12.

US District Court upholds FDA's approval of Avadel's narcolepsy drug Lumryz, rejecting Jazz Pharmaceuticals' claim that it infringes on Xywav's market exclusivity. The court ruled Lumryz's single-dose regimen as clinically superior, allowing Avadel to market Lumryz with its own seven-year exclusivity.

Avadel Pharmaceuticals' LUMRYZ received a favorable court ruling affirming FDA approval, despite Jazz Pharmaceuticals' challenge under the Orphan Drug Act. LUMRYZ, the only once-at-bedtime oxybate treatment for narcolepsy, was also approved for pediatric use and demonstrated efficacy in clinical trials. Avadel anticipates operating income in Q3 2024, with analysts projecting over $600 million in sales by 2030. A study found 94% of participants preferred LUMRYZ over twice-nightly treatments.

A D.C. federal judge upheld the FDA's determination that a rival narcolepsy treatment is not the 'same drug' as Jazz Pharmaceuticals' exclusive treatment, ruling the FDA's approval did not violate the Orphan Drug Act.