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Newron Not Seeing Sarizotan STARS Yet

FDA Calls Meeting To Discuss Rett Drug

 
• By Kevin Grogan

The Italian firm has some talking to do with the US FDA before it can unblind Phase III data on sarizotan, its Rett syndrome therapy which could be "potentially transformative" for Newron.

Roadworks
Final sarizotan data delayed • Source: Shutterstock

Investors in Newron Pharmaceuticals SPA have reacted nervously to the news that US regulators have called in the Italian drugmaker for discussions about its Rett syndrome drug, sarizotan, before pivotal data from a late-stage trial can be unblinded.

The Milan-based group was expected to release data from the Phase III STARS trial evaluating sarizotan in patients with Rett who are suffering from respiratory symptoms before the end of...

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