FDA releases MannKind from Afrezza malignancy study; sBLA for children PDUFA May 29

MANNKIND CORP

FDA informed MannKind on May 27, 2026 it is released from postmarketing requirement to assess pulmonary malignancy risk in 8,000-10,000 patients.
Only remaining postmarketing requirement for Afrezza is pediatric safety/efficacy; sBLA for ages 4-17 has PDUFA target action date May 29, 2026.
INHALE-1st study for youth (10-17) with type 1 diabetes activated eight additional sites; expects up to 100 participants across 10 sites.
Primary endpoint of INHALE-1st: percentage with CGM time in range ≥70% at 13 weeks; data expected late 2027.

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