MNKD MannKind
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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
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Jun 3, 2026
3d ago
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Press Release
| $3.36 $3.52 | ▲ +4.76% | ▲ +4.36% | $3.40 (+1.19%) |
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Jun 2, 2026
4d ago
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8-K
| $3.43 $3.36 | ▼ −2.04% | ▼ −1.35% | $3.40 (−0.87%) |
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May 29, 2026
8d ago
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Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.40 (−9.81%) |
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May 29, 2026
8d ago
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Press Release
| $3.77 $3.53 | ▼ −6.37% | ▼ −6.64% | $3.40 (−9.81%) |
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May 28, 2026
9d ago
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8-K
| $3.64 $3.77 | ▲ +3.57% | ▲ +3.33% | $3.40 (−6.59%) |
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May 27, 2026
10d ago
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Press Release
| $3.55 $3.64 | ▲ +2.54% | ▲ +1.98% | $3.40 (−4.23%) |
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May 12, 2026
25d ago
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Insider Cluster
| $3.28 $3.21 | ▼ −2.13% | ▼ −2.71% | $3.40 (+3.66%) |
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May 6, 2026
4w ago
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Press Release
| $3.55 $3.55 | · 0.00% | ▲ +0.83% | $3.40 (+4.23%) |
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Apr 7, 2026
8w ago
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DEFA14A
| $2.61 $2.56 | ▼ −1.92% | ▼ −2.49% | $3.40 (+30.27%) |
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Feb 26, 2026
14w ago
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8-K
| $3.24 $3.28 | ▲ +1.23% | ▲ +1.69% | $3.40 (+4.94%) |
US Market Status
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