secwatch.observer — SEC 8-K summary
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Issuer:     MANNKIND CORP (MNKD)
CIK:        0000899460
Form:       8-K
Filed at:   2026-05-28T12:37:11+00:00
Accession:  0001193125-26-243074
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/0001193125-26-243074-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/mnkd-20260527.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-243074

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer