Pharming Group Delays Leniolisib EU Approval

Pharming Group (PHAR) has released an update.

Pharming Group N.V. has provided an update on the European regulatory review of leniolisib, indicating that while the CHMP has acknowledged the drug’s positive clinical benefit and safety, there is a delay in approval due to a manufacturing request. The company, which maintains its 2022 revenue guidance, has already begun addressing the CHMP’s requirements and seeks approval for leniolisib, currently available in the U.S., for patients with APDS in Europe.

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