CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage. Between 74-89% of retail investor accounts lose money when trading CFDs. You should consider whether you understand how CFDs work and whether you can afford to take the high risk of losing your money. Please refer to our Risk Disclosure Statement
Open platformOpen platform

FDA declines approval of Novocure's Optune Mya over uncertain clinical benefit

By Public Technologies
  • The FDA issued Novocure a not approvable letter for Optune Mya, blocking its premarket approval application.
  • The application covers adults with brain metastases from non-small cell lung cancer following stereotactic radiation.
  • Uncertainty over the degree of clinical benefit prevented approval; the FDA raised no safety concerns.
  • Novocure plans to meet with the FDA to explore potential approval options without additional clinical studies.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novocure Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 202611090700BIZWIRE_USPR_____20261109_BW483647) on November 09, 2026, and is solely responsible for the information contained therein.

Capital Com is an execution-only service provider. The present material must be regarded as marketing communication and should not be interpreted as investment research or investment advice. Any opinion that may be provided on this page does not constitute a recommendation by Capital Com or its agents. We do not make any representations or warranty on the accuracy or completeness of the information that is provided on this page. If you rely on the information on this page, then you do so entirely at your own risk