MannKind released from FDA postmarketing trial requirement for Afrezza diabetes drug

Filed May 28, 2026 · Period ending May 27, 2026 · ~1 min read

Key Changes

• high

  FDA released MannKind from a major postmarketing requirement mandating a 5-year trial in 8,000-10,000 patients to assess lung cancer risk, eliminating a significant regulatory burden that had been in place since 2014 approval.

  Item 8.01 verify on EDGAR →
• high

  FDA decision on pediatric supplemental application for Afrezza in children aged 4-17 with diabetes is due May 29, 2026 (one day after this filing), which could expand the addressable market if approved.

  Item 8.01 verify on EDGAR →
• medium

  Company expanded INHALE-1st trial to 10 sites enrolling up to 100 youth patients aged 10-17 with newly-diagnosed type 1 diabetes, with data expected in late 2027 to support additional pediatric indications.

  Item 8.01 verify on EDGAR →