JAZZ PHARMACEUTICALS FRANCE

Jazz Pharmaceuticals' drug Ziihera, for HER2-positive biliary tract cancer, received FDA accelerated approval. It showed a 52% response rate in a study but caused serious adverse reactions in 53% of patients. Jazz aims to further research for HER2-expressing cancers.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for HER2-positive BTC, based on a 52% objective response rate and 14.9-month median duration of response. Zymeworks earned a $25M milestone payment and is eligible for up to $500M in regulatory milestones. Zanidatamab is also under regulatory review in China and Europe, and is being investigated in Phase 3 trials for gastroesophageal adenocarcinomas and metastatic breast cancer.

Jazz Pharmaceuticals announces FDA accelerated approval of Ziihera, the first dual HER2-targeted bispecific antibody for HER2+ biliary tract cancer, based on a 52% objective response rate and 14.9-month median duration of response from the HERIZON-BTC-01 trial. Continued approval may depend on results from the ongoing Phase 3 HERIZON-BTC-302 trial.

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.