FDA Acceptance, Priority Review For Leniolisib In Children With APDS

Pharming

01/10/2025 06:06

Adds dropped 'Supplemental NDA' in headline.

Oct 1 (Reuters) - Pharming Group NV PHAR.AS:

PHARMING GROUP ANNOUNCES U.S. FDA ACCEPTANCE AND PRIORITY REVIEW OF SUPPLEMENTAL NEW DRUG APPLICATION FOR LENIOLISIB IN CHILDREN WITH APDS AGED 4 TO 11 YEARS

PDUFA TARGET ACTION DATE SET FOR JANUARY 31, 2026

DECISION BASED ON POSITIVE PHASE III STUDY DATA

Source text: ID:nGNX5rKzxJ

Further company coverage: PHAR.AS

 (Gdansk Newsroom)

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