Harmony Biosciences Holdings, Inc.
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Latest From Harmony Biosciences Holdings, Inc.
Plus deals involving SK Biopharmaceuticals, Hikma and Proteovant, Day One/Sprint, Eyenovia/Formosa, Clinigen/CNX, Ikena/Pionyr and more.
Public Company Edition: Sage will reveal cost reductions later in the third quarter after the US FDA approved zuranolone for the smaller of two depression indications. Also, Karyopharm revealed a 20% workforce reduction, Harmony accessed up to $185m in debt and Astellas invested $50m in Poseida.
The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
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