MannKind Advances Inhaled IPF Drug to Global Phase 2, Eyes FUROSCIX Growth

Key Points

• MannKind is advancing inhaled nintedanib into a global Phase 2 IPF trial expected to enroll about 140 patients across 12–13 countries. Early studies reported no notable diarrhea, cough-related discontinuations, or major tolerability issues, but efficacy remains the key test.
• The company is diversifying revenue through FUROSCIX ReadyFlow, with 90% of new prescriptions in its first three weeks reportedly coming from the auto-injector. MannKind expects a strong fourth quarter and is assessing ways to accelerate growth into 2027.
• MannKind says it has sufficient cash to fund its launches and pipeline without raising capital. Afrezza’s pediatric market share has already surpassed its adult share, while the GenRALD inhaled ralinepag program could enter human testing by year-end.

MannKind NASDAQ: MNKD Chief Executive Officer Mike Castagna said the company is advancing an inhaled version of nintedanib into a global Phase 2 study for idiopathic pulmonary fibrosis, or IPF, following early safety and tolerability results that did not show the gastrointestinal issues often associated with oral nintedanib.

Speaking during a conference panel on IPF therapies, Castagna said MannKind’s INFLO-2 trial is expected to enroll about 140 patients across 12 or 13 countries, subject to discussions with the U.S. Food and Drug Administration. The study will test two doses of inhaled nintedanib.

“So far, I think we’ve dosed 60, 70 patients between healthy volunteers and IPF patients,” Castagna said, referring to early-stage studies. “We’ve seen no inclination of diarrhea. We’ve seen no discontinuations for cough, nothing for tolerability.”

He said the early findings gave MannKind confidence to move into Phase 2, while acknowledging that the key remaining question will be efficacy. Castagna said recent results involving inhaled therapies have supported the potential for delivering drugs directly to the lungs in IPF.

IPF Pipeline and Combination Treatment

IPF is a progressive lung disease in which current antifibrotic therapies can slow lung-function decline but may be limited by tolerability issues. During the panel, pulmonologist Kristin Berger of Weill Cornell Medicine said the field is likely moving toward combination therapy, particularly if newer medicines can improve tolerability.

Castagna said MannKind’s nintedanib study allows certain background treatments, including JASCAYD, nebulized TYVASO and pirfenidone. Patients who previously tried and could not tolerate nintedanib may also be eligible, he said.

The company also has exposure to TYVASO DPI through its relationship with United Therapeutics. Castagna said the FDA would likely require an efficacy-focused Phase 3 study before extending an IPF label to the dry-powder inhaler formulation, rather than relying solely on pharmacokinetic or pharmacodynamic data.

He added that a potential regulatory pathway involving one trial rather than two would be favorable, though questions remain around the required effect size and whether results in IPF could be extended to progressive pulmonary fibrosis, or PPF.

Castagna also discussed MannKind’s inhaled ralinepag program, which he said is now being called GenRALD. He said the program could enter human testing by the end of the year and potentially move into a Phase 2 IPF study late next year. He cited an AI-model projection discussed by another speaker that suggested a potential lung-function delta of up to 150 milliliters, while characterizing the figure as a model-based prediction rather than clinical data.

Revenue Diversification and FUROSCIX Launch

Addressing the company’s revenue mix, Castagna said MannKind has been working to reduce dependence on its partnership with United Therapeutics. He pointed to MannKind’s acquisition of scPharmaceuticals and the launch of FUROSCIX ReadyFlow, an auto-injector version of its furosemide product for heart failure patients.

Castagna said 90% of new FUROSCIX prescriptions in the first three weeks following the ReadyFlow launch were for the auto-injector. He said the adoption rate was faster than the company had expected and suggested the on-body infuser would remain available for another year.

“Convenience usually wins in markets and it is good to see that here,” Castagna said. He added that MannKind expects the fourth quarter to be a strong period for FUROSCIX and is evaluating how to accelerate growth into 2027.

On Afrezza, MannKind’s inhaled insulin product, Castagna said the company shifted roughly half of its adult-focused sales effort toward nephrology to support FUROSCIX. He said that decision reduced momentum in the adult Afrezza business, but pediatric adoption has been encouraging since the pediatric label was approved.

According to Castagna, Afrezza’s pediatric market share surpassed its adult market share within 90 days, despite the product having been available in adults for about a decade.

Financial Position

Castagna said MannKind has invested during the year in two product launches and the Phase 2 nintedanib study. He said the company has sufficient cash to fund innovation and growth and does not need to raise capital. He added that MannKind could become profitable next year if profitability became its primary objective.

“The company’s in major growth mode,” Castagna said, citing its in-line products, pipeline programs and relationship with United Therapeutics.

Also on the panel, Vicore Pharma CEO Ahmed Mousa discussed the company’s Phase 2b ASPIRE study of buloxibutid, an oral AT2 receptor agonist designed to address epithelial repair in IPF. Mousa said the study has enrolled nearly 400 patients and is evaluating lung function over 52 weeks, with results expected in the summer of next year. He said Vicore expects a Phase 3 study would still be required after the Phase 2b trial.

About MannKind (NASDAQ:MNKD)

MannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF).

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