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Jazz Pharmaceuticals plc (JAZZ) Wins FDA Nod for Modeyso in Rare Pediatric Brain Tumors
Yahoo Finance· 2025-09-16 13:30
Company Overview - Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical leader focused on developing and commercializing therapies for complex conditions in oncology, neuroscience, and sleep medicine, with a portfolio that includes treatments for narcolepsy, epilepsy, and rare cancers [1]. Recent Developments - The company achieved a significant milestone with the FDA's accelerated approval of Modeyso (dordaviprone) on August 6, 2025, for treating H3 K27M-mutant diffuse midline glioma, a rare and aggressive brain cancer affecting approximately 2,000 patients annually in the U.S., primarily children and young adults [2]. - Modeyso is the first and only therapy approved for patients aged one year and older with progressive disease following prior treatment, demonstrating a 22% overall response rate in clinical trials among 50 patients, with a median response duration of 10.3 months; 73% of responders maintained their response for over six months [2]. - The drug is administered as a weekly oral capsule and will soon be commercially available, with continued approval dependent on the ongoing Phase 3 ACTION confirmatory trial [2]. Pipeline Expansion - In addition to Modeyso, Jazz Pharmaceuticals is diversifying its pipeline by licensing SAN2355, a preclinical epilepsy drug, thereby strengthening its neuroscience portfolio [3]. - In oncology, the company is advancing zanidatamab in Phase 3 for advanced gastroesophageal cancers and is pursuing regulatory approval for Zepzelca as a first-line treatment for extensive-stage small cell lung cancer [3].
JAZZ Inks $1B Licensing Deal With Saniona for Epilepsy Drug
ZACKS· 2025-08-21 14:50
Core Insights - JAZZ Pharmaceuticals has signed an agreement with Saniona to acquire worldwide rights to the investigational epilepsy drug SAN2355 [1][8] - SAN2355 is designed to selectively activate Kv7.2/Kv7.3 potassium channels, aiming to avoid safety issues associated with previous therapies like GSK's Potiga [2][3] - The deal allows JAZZ to enhance its neuroscience pipeline, complementing its existing epilepsy treatment, Epidiolex, which is expected to achieve blockbuster status [7][9] Financial Terms of the Deal - JAZZ will pay Saniona an upfront cash payment of $42.5 million, with potential milestone payments up to $192.5 million for development and regulatory achievements, and up to $800 million for commercial milestones [4] - Saniona will also receive royalties on future sales of SAN2355 [4] Market Context - JAZZ's stock has seen a decline of 3% year-to-date, contrasting with a 3% growth in the industry [5] - The acquisition of SAN2355 positions JAZZ for future innovation in the epilepsy market, potentially serving as a successor to Epidiolex once it loses exclusivity [9]
Jazz Pharmaceuticals Enters Exclusive Licensing Agreement with Saniona to Develop and Commercialize SAN2355
Prnewswire· 2025-08-20 11:30
Core Insights - Jazz Pharmaceuticals has entered into a global license agreement with Saniona to develop SAN2355, a selective Kv7.2/Kv7.3 activator for epilepsy and other indications, with Jazz obtaining exclusive worldwide rights [1][2] - The collaboration aims to leverage Jazz's expertise in epilepsy and neuroscience to advance SAN2355, which is positioned as a promising treatment option [2][3] Transaction Terms - Saniona will receive an upfront payment of US $42.5 million and is eligible for up to US $192.5 million in development and regulatory milestones, including a US $7.5 million payment upon the initiation of the first Phase 1 clinical study [3] - Additionally, Saniona could receive up to US $800 million in commercial milestone payments based on achieving significant annual net sales thresholds, along with tiered royalties ranging from mid-single digits to low-double digits on net sales of products developed from SAN2355 [3] Product Overview - SAN2355 is a preclinical small molecule activator specifically targeting Kv7.2/Kv7.3 potassium channels, which are validated for seizure suppression, and is designed to avoid adverse events associated with non-selective Kv7-targeting compounds [4] - The selectivity of SAN2355 for Kv7.2/Kv7.3 supports its potential as a best-in-class treatment for epilepsy, aiming to optimize dosing for efficacy [4] Company Background - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases, with a diverse portfolio that includes therapies for sleep disorders and epilepsy [5] - Saniona is a clinical-stage biopharmaceutical company dedicated to innovative treatments for neurological and psychiatric disorders, with a pipeline that includes SAN2219 for epilepsy and SAN2465 for major depressive disorder [6]