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.
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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3305858 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jul 29, 2026 9w ago | Press Release | $3.85 $4.09 | ▲ +6.23% | ▲ +1.21% | $3.74 (−2.86%) |
Jul 24, 2026 9w ago | 8-K | $3.95 $4.07 | ▲ +3.04% | ▼ −0.26% | $3.74 (−5.32%) |
Jul 18, 2026 10w ago | Insider Cluster | $3.98 $3.90 | ▼ −2.01% | ▼ −6.13% | $3.74 (−6.03%) |
Jun 3, 2026 17w ago | Press Release | $3.36 $4.52 | ▲ +34.52% | ▲ +35.52% | $3.74 (+11.31%) |
Jun 2, 2026 17w ago | 8-K | $3.43 $4.05 | ▲ +18.08% | ▲ +19.64% | $3.74 (+9.04%) |
May 29, 2026 18w ago | Press Release | $3.77 $4.24 | ▲ +12.47% | ▲ +14.26% | $3.74 (−0.80%) |
May 29, 2026 18w ago | Press Release | $3.77 $4.24 | ▲ +12.47% | ▲ +14.26% | $3.74 (−0.80%) |
May 28, 2026 18w ago | 8-K | $3.64 $4.14 | ▲ +13.74% | ▲ +16.88% | $3.74 (+2.75%) |
May 27, 2026 18w ago | Press Release | $3.55 $3.93 | ▲ +10.70% | ▲ +12.61% | $3.74 (+5.35%) |
May 12, 2026 20w ago | Insider Cluster | $3.28 $3.63 | ▲ +10.67% | ▲ +12.40% | $3.74 (+14.02%) |
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