MNKD MannKind
Price Chart
Executive Summary
MannKind announced FDA approval of Afrezza (inhaled insulin) for pediatric patients aged 6+ with type 1 and type 2 diabetes. This expands Afrezza's addressable population by >350,000 US children/adolescents with diabetes and represents a significant label expansion for MannKind's only marketed product. The approval is based on the Phase 3 INHALE-1 trial and 20+ years of safety data.
Actionable Insight
This is a material catalyst for MNKD — Afrezza's only marketed product now has a major label expansion into a large, needle-averse pediatric population. Traders should watch for prescription volume data over the next 2-4 quarters as a read on commercial uptake. The stock may gap up significantly on this news given the $1.1B market cap and largely adult-only revenue base prior to approval.
Key Facts
- FDA approved Afrezza for children/adolescents aged 6+ with type 1 and type 2 diabetes
- Over 350,000 US children/adolescents have diabetes, mostly type 1 requiring lifelong insulin
- Approval supported by Phase 3 INHALE-1 trial and 20+ years of clinical data
- Eligible patients pay $35/month or less through MannKind Cares
- Afrezza is the only ultra rapid-acting inhaled insulin and was previously approved only for adults (2014)
Financial Impact
Expands TAM by ~350K pediatric diabetes patients in the US; current MNKD market cap ~$1.1B. The pediatric approval likely adds $100-300M+ in peak revenue opportunity (based on typical inhaled insulin penetration) but exact figures are not stated.
Risk Factors
- Afrezza's commercial adoption in adults has been slow since 2014 launch; pediatric uptake may face similar barriers
- Competing with entrenched injectable insulin analogs and pumps; insurance coverage/reimbursement challenges
- Potential lung function concerns in growing children — long-term safety data are limited
- Black-box warning for bronchospasm in patients with chronic lung disease limits target population
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303734 |
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
|
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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