MNKD MANNKIND CORP
Price Chart
Executive Summary
MannKind announced FDA approval of Afrezza (insulin human) Inhalation Powder for pediatric use in children and adolescents aged 6+ with type 1 and type 2 diabetes. This also fulfills the last remaining postmarketing requirement from the original 2014 approval, removing a key regulatory overhang and opening a new patient population of over 350,000 U.S. children with diabetes.
Actionable Insight
This is a transformative regulatory catalyst that removes the last postmarketing requirement and expands the addressable market. Monitor upcoming quarterly results for initial pediatric prescription trends and any guidance update on revenue contribution.
Key Facts
- FDA approved Afrezza for pediatric use in patients aged 6 and older with type 1 and type 2 diabetes.
- Over 350,000 U.S. children and adolescents live with diabetes, majority type 1 requiring lifelong insulin.
- Pediatric sBLA fulfills the last remaining postmarketing requirement from the original June 27, 2014 approval letter.
- Approval date: May 29, 2026; 8-K filed June 2, 2026.
Financial Impact
Opens a new pediatric market of >350,000 patients; no specific revenue guidance provided in filing.
Risk Factors
- Pediatric adoption may be slower than expected due to competition from established insulin delivery methods.
- No financial terms or revenue projections disclosed in the filing.
Market Snapshot
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-252544 |
| Document: 0001193125-26-252544-index-headers.html | 0001193125-26-252544 |
| Document: 0001193125-26-252544-index.html | 0001193125-26-252544 |
| Document: 0001193125-26-252544.txt | 0001193125-26-252544 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 3, 2026
11d ago
|
Press Release
| $3.36 $3.52 | ▲ +4.76% | ▲ +4.36% | $3.66 (+8.93%) |
|
Jun 2, 2026
12d ago
|
8-K
| $3.43 $3.36 | ▼ −2.04% | ▼ −1.35% | $3.66 (+6.71%) |
|
May 29, 2026
16d ago
|
Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
|
May 29, 2026
16d ago
|
Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
|
May 28, 2026
17d ago
|
8-K
| $3.64 $3.77 | ▲ +3.57% | ▲ +3.33% | $3.66 (+0.55%) |
|
May 27, 2026
18d ago
|
Press Release
| $3.55 $3.64 | ▲ +2.54% | ▲ +1.98% | $3.66 (+3.10%) |
|
May 12, 2026
4w ago
|
Insider Cluster
| $3.28 $3.21 | ▼ −2.13% | ▼ −2.71% | $3.66 (+11.59%) |
|
May 6, 2026
5w ago
|
Press Release
| $3.55 $3.55 | · 0.00% | ▲ +0.83% | $3.66 (−3.10%) |
|
Apr 7, 2026
9w ago
|
DEFA14A
| $2.61 $2.56 | ▼ −1.92% | ▼ −2.49% | $3.66 (+40.23%) |
|
Feb 26, 2026
15w ago
|
8-K
| $3.24 $3.28 | ▲ +1.23% | ▲ +1.69% | $3.66 (+12.96%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access