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Jazz Pharmaceuticals announced CEO Bruce Cozadd's retirement plan; he will stay on until a successor is found within a year. Cozadd co-founded Jazz in 2003 and led it through significant growth, including the $7 billion acquisition of GW Pharmaceuticals. The company remains on track to meet its 2024 revenue guidance of $4 billion to $4.1 billion, with a focus on Xywav and Epidiolex. A special committee of independent directors will lead the search for Cozadd's replacement, considering both internal and external candidates.

Jazz Pharmaceuticals received FDA approval for Ziihera, a HER2-targeted therapy for HER2+ biliary tract carcinoma, with a list price of $35,500 per cycle. Piper Sandler reaffirmed its Overweight rating and $163 price target, highlighting growth in the oncology segment. Jazz's strong financial health supports portfolio expansion, with anticipation for 2025 data on Ziihera in first-line HER2+ gastroesophageal adenocarcinoma.

Jazz Pharmaceuticals (JAZZ) posted Q3 top-and-bottom-line beats, projecting 2024 earnings above expectations, driven by sales growth from Xywav and Epidiolex. The company received accelerated approval for Ziihera, a treatment for HER2-positive biliary tract cancer, and anticipates phase 3 PFS results on Zanidatamab. JAZZ trades at a discount to peers, making it attractive for value investors.

The District Court upheld FDA's decision that Avadel's Lumryz is clinically superior to Jazz's Xywav, granting Lumryz its own orphan drug exclusivity. Jazz argued FDA's decision violated the Administrative Procedure Act, but the Court found FDA's determination was within its statutory authority and not arbitrary or capricious.

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.

A federal judge ruled the FDA didn’t break orphan drug exclusivity by approving Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival to Jazz Pharmaceuticals PLC’s Xywav.

The U.S. District Court for the District of Columbia ruled in favor of the FDA in a suit by Jazz Pharmaceuticals regarding the approval of Avadel Pharmaceuticals' LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. The court upheld LUMRYZ's approval based on its clinical superiority to Jazz's twice-nightly oxybate products, allowing LUMRYZ to retain its Orphan Drug Exclusivity.

Overdrive Defense launches 3-in-1 Drink Spike Defense Test Kit, detecting GHB, Rohypnol, and Ketamine, available at 5,000 CVS Pharmacy stores and online.