MNKD MANNKIND CORP
Price Chart
Executive Summary
MannKind announced the FDA released it from a postmarketing requirement for Afrezza—a five-year pulmonary malignancy study in 8,000-10,000 type 2 diabetes patients—eliminating a major regulatory overhang. The only remaining postmarketing requirement is a pediatric efficacy/safety assessment, with a PDUFA target action date of May 29, 2026. Separately, the company provided a clinical update on the INHALE-1st pediatric study, with data expected in late 2027.
Actionable Insight
The FDA release from the pulmonary malignancy study is a clear positive catalyst, removing a long-standing regulatory overhang. The upcoming PDUFA date (May 29, 2026) for the pediatric sBLA adds near-term binary catalyst risk. Traders should watch for the pediatric decision as the next major event.
Key Facts
- FDA released MannKind from a postmarketing requirement to assess pulmonary malignancy risk in 8,000-10,000 Afrezza patients
- Only remaining postmarketing requirement is pediatric efficacy/safety assessment (sBLA accepted October 2025, PDUFA date May 29, 2026)
- INHALE-1st study: 8 additional sites activated, up to 100 participants expected, data expected late 2027
Financial Impact
Elimination of a costly, multi-year postmarketing study removes a significant future expense and regulatory risk; no dollar amount disclosed
Risk Factors
- PDUFA decision on pediatric sBLA (May 29, 2026) could result in a Complete Response Letter
- INHALE-1st data not expected until late 2027, limiting near-term pipeline catalysts
- No financial figures disclosed; cost savings from released postmarketing requirement are unquantified
Market Snapshot
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-243074 |
| Document: 0001193125-26-243074-index-headers.html | 0001193125-26-243074 |
| Document: 0001193125-26-243074-index.html | 0001193125-26-243074 |
| Document: 0001193125-26-243074.txt | 0001193125-26-243074 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 3, 2026
10d ago
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Press Release
| $3.36 $3.52 | ▲ +4.76% | ▲ +4.36% | $3.66 (+8.93%) |
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Jun 2, 2026
10d ago
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8-K
| $3.43 $3.36 | ▼ −2.04% | ▼ −1.35% | $3.66 (+6.71%) |
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May 29, 2026
14d ago
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Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
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May 29, 2026
14d ago
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Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
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May 28, 2026
15d ago
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8-K
| $3.64 $3.77 | ▲ +3.57% | ▲ +3.33% | $3.66 (+0.55%) |
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May 27, 2026
16d ago
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Press Release
| $3.55 $3.64 | ▲ +2.54% | ▲ +1.98% | $3.66 (+3.10%) |
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May 12, 2026
4w ago
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Insider Cluster
| $3.28 $3.21 | ▼ −2.13% | ▼ −2.71% | $3.66 (+11.59%) |
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May 6, 2026
5w ago
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Press Release
| $3.55 $3.55 | · 0.00% | ▲ +0.83% | $3.66 (−3.10%) |
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Apr 7, 2026
9w ago
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DEFA14A
| $2.61 $2.56 | ▼ −1.92% | ▼ −2.49% | $3.66 (+40.23%) |
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Feb 26, 2026
15w ago
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8-K
| $3.24 $3.28 | ▲ +1.23% | ▲ +1.69% | $3.66 (+12.96%) |
US Market Status
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