MannKind's Inhaled IPF Drug Shows Clean Safety in Phase 1b, Phase 2 Enrolling
MNKD sits 81% above its 52-week low of $2.23.
Summary
MannKind's Phase 1b INFLO-1 trial of inhaled nintedanib DPI in IPF patients met its primary safety goal with no serious adverse events, no GI side effects, and no bronchospasm—a stark contrast to the known tolerability issues of oral nintedanib. The clean profile across 27 patients validates the Technosphere platform's ability to deliver drug directly to the lung while avoiding systemic toxicity. With Phase 2 INFLO-2 now actively enrolling 210 patients globally, the program is advancing toward efficacy data that could position nintedanib DPI as a differentiated therapy in a market with significant unmet need. This follows a series of positive regulatory and pipeline milestones for MannKind, including FDA approvals for Afrezza pediatric use and Furoscix ReadyFlow, and a recent $50M financing. The Phase 1b data de-risks the inhaled approach and strengthens the case for a pivotal program.
At the time of this announcement, MNKD was trading at $4.03 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.2B. The 52-week trading range was $2.23 to $6.51. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.