MNKD MannKind
Price Chart
Executive Summary
MannKind announced completion of patient randomization in the U.S. Phase 1b INFLO-1 trial and enrollment of the first patient in the global Phase 2 INFLO-2 study for nintedanib DPI (MNKD-201) in idiopathic pulmonary fibrosis. Phase 1b data readout is expected in Q3 2026, representing a key clinical milestone for the program.
Actionable Insight
Phase 1b data readout in Q3 2026 is the next major catalyst. Monitor for safety/tolerability and pharmacokinetic results that could de-risk the Phase 2 program. No financial guidance or commercial timeline provided.
Key Facts
- Phase 1b INFLO-1 patient randomization completed; data readout expected Q3 2026
- First patient enrolled in global Phase 2 INFLO-2 study (target ~210 participants across ~85 sites)
- Nintedanib DPI (MNKD-201) uses Technosphere dry powder inhalation technology to deliver drug directly to lungs
- INFLO-2 is a randomized, double-blind, placebo-controlled trial with 12-week treatment period and 24-week open-label extension
- Primary objective of INFLO-2 is safety and tolerability; secondary includes FVC decline rate
Financial Impact
No financial data provided; program is in early clinical development with no revenue contribution expected near-term
Risk Factors
- Clinical trial failure risk: nintedanib DPI may not demonstrate adequate safety or efficacy in Phase 2
- Competition from approved oral nintedanib and other IPF therapies
- Regulatory and manufacturing risks for inhaled formulation
- No revenue from this program for several years if successful
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3305858 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 3, 2026
9d ago
|
Press Release
| $3.36 $3.52 | ▲ +4.76% | ▲ +4.36% | $3.66 (+8.93%) |
|
Jun 2, 2026
10d ago
|
8-K
| $3.43 $3.36 | ▼ −2.04% | ▼ −1.35% | $3.66 (+6.71%) |
|
May 29, 2026
14d ago
|
Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
|
May 29, 2026
14d ago
|
Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.66 (−2.92%) |
|
May 28, 2026
15d ago
|
8-K
| $3.64 $3.77 | ▲ +3.57% | ▲ +3.33% | $3.66 (+0.55%) |
|
May 27, 2026
16d 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