MannKind Co.

MannKind reports positive topline results from the randomized, double‑blind phase‑1b study INFLO‑1 of inhaled nintedanib as a dry powder in patients with idiopathic pulmonary fibrosis (IPF). The 27‑patient study showed no serious adverse events, no drug‑related gastrointestinal side effects, no bronchospasms and no discontinuations or dose reductions; cough was mostly mild and transient. Overall, IPF patients received about 450 inhalations; combined with phase‑1a, 48 people were treated, 18 of them with IPF. The global phase‑2 study INFLO‑2 to further evaluate nintedanib DPI is currently recruiting and is expected to enroll around 210 participants. » Mais em de.investing.com

Wells Fargo raised its price target on MannKind to $11 and kept an Overweight rating, citing FDA approval of Afrezza for patients aged 6 and older and supportive INHALE‑1 data. The approval expands Afrezza’s market to pediatric patients and caregivers. MannKind also highlighted potential near‑term upside from up to $35 million in development milestones, a 10% royalty on net sales and its role as sole manufacturer of Tyvaso DPI. » Mais em finance.yahoo.com

MannKind has completed randomization of patients in the phase‑1b trial INFLO‑1 and has enrolled the first patient in the global phase‑2 trial INFLO‑2 for Nintedanib DPI. INFLO‑1 evaluates safety, tolerability and pharmacokinetics; results are expected in Q3 2026. INFLO‑2 aims to recruit about 210 participants at roughly 85 sites in a randomized, double‑blind 1:1:1 design over 12 weeks (with a 24‑week open extension) for dose finding and safety assessment. » Mais em de.investing.com