MannKind Announces Expansion of United Therapeutics Collaboration for Second Inhaled Therapy
MannKind Corporation (NASDAQ: MNKD) has expanded its collaboration with United Therapeutics (NASDAQ: UTHR) to develop a second dry powder inhalation therapy. This follows their successful partnership that resulted in Tyvaso DPI, the first FDA-approved dry powder inhalation treatment for pulmonary hypertension.
Under the expanded agreement, MannKind will utilize its Technosphere® platform to formulate a new investigational molecule, while United Therapeutics will handle preclinical and clinical development. The deal includes an upfront payment of $5 million to MannKind, potential development milestones up to $35 million, and 10% royalties on net sales of any resulting product.
MannKind Corporation (NASDAQ: MNKD) ha ampliato la collaborazione con United Therapeutics (NASDAQ: UTHR) per sviluppare una seconda terapia inalatoria a polvere secca. Questa estensione segue la partnership che ha portato a Tyvaso DPI, primo trattamento inalatorio a polvere secca approvato dalla FDA per l'ipertensione polmonare.
Con il nuovo accordo, MannKind impiegherà la sua piattaforma Technosphere® per formulare una nuova molecola sperimentale, mentre United Therapeutics si occuperà dello sviluppo preclinico e clinico. L'intesa prevede un pagamento iniziale di 5 milioni di dollari a MannKind, possibili traguardi di sviluppo fino a 35 milioni di dollari e royalty del 10% sulle vendite nette di eventuali prodotti risultanti.
MannKind Corporation (NASDAQ: MNKD) ha ampliado su colaboración con United Therapeutics (NASDAQ: UTHR) para desarrollar una segunda terapia inhalada en polvo seco. Esto se produce tras la alianza que dio lugar a Tyvaso DPI, el primer tratamiento inhalado en polvo seco aprobado por la FDA para la hipertensión pulmonar.
Bajo el acuerdo ampliado, MannKind empleará su plataforma Technosphere® para formular una nueva molécula en investigación, mientras que United Therapeutics asumirá el desarrollo preclínico y clínico. El acuerdo incluye un pago inicial de 5 millones de dólares a MannKind, posibles pagos por hitos de desarrollo de hasta 35 millones de dólares y royalties del 10% sobre las ventas netas de cualquier producto resultante.
MannKind Corporation (NASDAQ: MNKD)는 United Therapeutics (NASDAQ: UTHR)와의 협력을 확대해 두 번째 건식 분말 흡입 요법을 개발합니다. 이번 확장은 폐고혈압 치료를 위한 FDA 승인 첫 건식 분말 흡입 치료제인 Tyvaso DPI 개발에 성공한 기존 파트너십에 이은 것입니다.
확대된 계약에 따라 MannKind는 새로운 연구용 분자를 제형화하기 위해 Technosphere® 플랫폼을 활용하고, United Therapeutics는 전임상 및 임상 개발을 담당합니다. 계약에는 MannKind에 대한 초기 지급금 500만 달러, 최대 3,500만 달러의 개발 마일스톤, 그리고 최종 제품의 순매출에 대한 10% 로열티가 포함됩니다.
MannKind Corporation (NASDAQ: MNKD) a étendu sa collaboration avec United Therapeutics (NASDAQ: UTHR) pour développer une deuxième thérapie inhalée en poudre sèche. Cette extension fait suite au partenariat qui a abouti à Tyvaso DPI, le premier traitement inhalé en poudre sèche approuvé par la FDA pour l'hypertension pulmonaire.
Dans le cadre de l'accord étendu, MannKind utilisera sa plateforme Technosphere® pour formuler une nouvelle molécule expérimentale, tandis que United Therapeutics prendra en charge le développement préclinique et clinique. L'accord prévoit un paiement initial de 5 millions de dollars à MannKind, des jalons de développement pouvant atteindre 35 millions de dollars et des redevances de 10% sur les ventes nettes de tout produit résultant.
MannKind Corporation (NASDAQ: MNKD) hat seine Zusammenarbeit mit United Therapeutics (NASDAQ: UTHR) ausgeweitet, um eine zweite Trockenpulver-Inhalationstherapie zu entwickeln. Dies folgt auf die erfolgreiche Partnerschaft, die Tyvaso DPI hervorbrachte, die erste von der FDA zugelassene Trockenpulver-Inhalationsbehandlung bei pulmonaler Hypertonie.
Im Rahmen der erweiterten Vereinbarung wird MannKind seine Technosphere®-Plattform zur Formulierung eines neuen Prüfstoffs einsetzen, während United Therapeutics die präklinische und klinische Entwicklung übernimmt. Die Vereinbarung umfasst eine Anfangszahlung von 5 Millionen US-Dollar an MannKind, mögliche Entwicklungsmeilensteine von bis zu 35 Millionen US-Dollar sowie 10% Tantiemen auf den Nettoumsatz eines eventuell entstehenden Produkts.
- None.
- Development success not guaranteed for new investigational molecule
- Timeline to potential commercialization not specified
- Significant R&D and clinical trial risks ahead
Initial collaboration led to Tyvaso DPI®, the first FDA-approved dry powder inhalation treatment for pulmonary hypertension
DANBURY, Conn. and BOSTON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that United Therapeutics Corporation (Nasdaq: UTHR) has exercised its option—granted under the companies’ 2018 license and collaboration agreement—to develop a second dry powder inhalation therapy.
The original agreement, which led to U.S. FDA approval of Tyvaso DPI in May 2022, included an option for United Therapeutics to expand the license to include additional active ingredients. Under the terms of the expanded agreement, MannKind will formulate a second investigational molecule using its proprietary Technosphere® platform, and United Therapeutics will conduct preclinical and clinical development.
“Building on the success of Tyvaso DPI, we are proud to deepen our collaboration with United Therapeutics to bring innovative patient-centric inhaled therapies to patients living with pulmonary hypertension,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “This next step highlights the strength of our partnership and the versatility of our dry powder formulations and inhalation devices in addressing serious respiratory conditions.”
Under the terms of the expanded agreement, MannKind will receive an upfront payment of
Formulation and development activities for the new investigational molecule will begin immediately.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.
Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the potential development of an investigational product and receipt of milestone payments and royalties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of an investigational drug product may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
TYVASO DPI is a registered trademark of United Therapeutics Corporation.
TECHNOSPHERE and MANNKIND are registered trademarks of MannKind Corporation.
MannKind Contacts: Investor Relations Ana Kapor, (818) 661-5000 Email: ir@mnkd.com Media Relations Christie Iacangelo, (818) 292-3500 Email: media@mnkd.com
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