secwatch / observer

8-K filed May 28, 2026, 8:37 AM ET ticker MNKD CIK 0000899460

regulatory confidence high sentiment positive materiality 0.70

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.

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001193125-26-243074
form_type: 8-K
ticker: MNKD
cik: 0000899460
company_name: MANNKIND CORP
filed_at: 2026-05-28T12:37:11+00:00
discovered_at: 2026-05-28T13:00:00.339259+00:00
generated_at: 2026-05-28T13:08:52.407084+00:00
sec_items: ["8.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: high
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markdown_url: https://secwatch.observer/filing/0001193125-26-243074.md
text_url: https://secwatch.observer/filing/0001193125-26-243074.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/0001193125-26-243074-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/mnkd-20260527.htm
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review_status: machine_generated
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correction_note: null
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superseded_by: null

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