MannKind files legal opinion for common stock offering under shelf registration

MannKind (MNKD) shares rose 5% after FDA approved Afrezza for diabetes treatment in children aged 6+. The approval follows Phase 3 trial data showing Afrezza's noninferiority to injections in HbA1c changes, with higher patient satisfaction and less weight gain. Afrezza uses Technosphere tech for rapid insulin delivery via inhalation.

The FDA accepted United Therapeutics' NDA for ralinepag, a PAH treatment, with a PDUFA target date of June 24, 2027. The application is based on Phase III trial results showing a 55% reduction in clinical worsening events. If approved, ralinepag would be the first once-daily oral prostacyclin IP receptor agonist for PAH. The company also plans to develop a dry powder inhalation formulation with MannKind.

Three Connecticut firms outlined different financing paths. New Silver said it acquired Mayflower Venture Partners to expand lending in New England, with deal terms undisclosed. American Battery Materials filed to raise about $16.3M for Utah lithium and magnesium exploration, targeting production in 2029. MannKind raised $50M after FDA approval of Furoscix ReadyFlow, funding a $45M milestone payment and aiming for U.S. sales by end-August.

MANNKIND CORP (MNKD) filed an SEC Form 8-K — Results of Operations and Financial Condition. MannKind Reports Second Quarter 2026 Financial Results and Provides Business Update • Achieved three major catalysts to drive future growth: o Launched the pediatric indication of Afrezza ® following FDA approval o FUROSCIX ReadyFlow™ autoinjector approved for treatment of edema

MannKind (MNKD) reported positive topline Phase 1b INFLO-1 results for nintedanib dry powder inhalation in idiopathic pulmonary fibrosis. In a randomized, double-blind, placebo-controlled trial of 27 patients, it met the primary objective of safety and tolerability, with no serious adverse events, GI effects, bronchospasm, or discontinuations. MannKind is enrolling Phase 2 INFLO-2.

MannKind (Nasdaq: MNKD) reported positive topline Phase 1b INFLO-1 results for nintedanib dry powder inhalation (DPI) in idiopathic pulmonary fibrosis. In 27 patients, it met safety and tolerability goals with no serious adverse events, no bronchospasm or diarrhea, and no discontinuations. Phase 2 INFLO-2 is enrolling about 210 patients.