MannKind Announces Ralinepag Dry Powder Inhalation (DPI) Program to be Pursued for Pulmonary Hypertension and Fibrotic Lung Diseases

Rhea-AI Summary

MannKind (Nasdaq: MNKD) and United Therapeutics announced development of ralinepag DPI (MNKD-1501), a dry powder inhalation formulation for pulmonary arterial hypertension and fibrotic lung diseases. United Therapeutics paid MannKind an additional $5 million in April 2026 and will be primary manufacturer.

MannKind is eligible for up to $35 million in development milestones and 10% royalties on net sales; plans include phase 1 PK comparability studies and later pivotal trials for PAH and additional studies for PH-ILD, IPF, and PPF.

Positive

• United Therapeutics paid $5 million to MannKind in April 2026
• MannKind eligible for up to $35 million in development milestones
• Potential 10% royalty on net sales of any commercial ralinepag DPI
• United Therapeutics to be primary manufacturer, leveraging existing commercialization capability

Negative

• Ralinepag is not approved in any jurisdiction in any formulation
• Additional clinical studies required for PH-ILD, IPF, and PPF before approvals
• Milestone payments and royalties depend on future clinical and regulatory success

News Market Reaction – MNKD

+24.48% 1.9x vol

69 alerts

+24.48% Session close to close

+38.6% Peak Tracked

-2.3% Trough Tracked

$1.32B Market Cap

1.9x Rel. Volume

In the May 6 session, MNKD gained 24.48%, reflecting a significant positive market reaction. Argus tracked a peak move of +38.6% during that session. Argus tracked a trough of -2.3% from its starting point during tracking. Our momentum scanner triggered 69 alerts that day, indicating high trading interest and price volatility. Trading volume was above average at 1.9x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +24.5% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +24.5% in the session following this news. A strong positive reaction aligns with the constructive nature of this collaboration news. MannKind highlighted new non-dilutive economics from United Therapeutics, including a $5 million payment, up to $35 million in milestones, and 10% royalties tied to ralinepag DPI. Historical data show that some positive fundamental events, such as the Feb 26, 2026 earnings report, previously saw selloffs, so any sharp upside move would have contrasted with that pattern and could have been sensitive to shifts in sentiment or profit-taking.

Key Figures

Collaboration payment: $5 million Development milestones: $35 million Royalty rate: 10% royalties +1 more

4 metrics

Collaboration payment $5 million Additional payment from United Therapeutics in April 2026

Development milestones $35 million Maximum development milestone payments MannKind may receive

Royalty rate 10% royalties Royalties on net sales of any resulting ralinepag DPI product

Tyvaso DPI revenue $1.3B 2025 revenue reported for Tyvaso DPI by United Therapeutics

Historical Context

5 past events · Latest: Apr 29 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 29	Earnings date notice	Neutral	+2.9%	Announcement of timing and webcast details for Q1 2026 results.
Mar 09	Clinical data update	Positive	+2.7%	New Afrezza pediatric and adult data presentations at ATTD 2026.
Mar 05	Debt settlement	Positive	-7.8%	Settlement of remaining $36.3M 2.50% convertible senior notes.
Mar 04	Investor conferences	Neutral	+0.8%	Participation in March investor conferences with executive presentations.
Feb 26	Earnings and update	Positive	-7.4%	Strong Q4/FY 2025 growth, scPharma deal, cash position and PDUFA timelines.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent history shows mixed reactions: some strong fundamental updates and debt reduction were met with notable selloffs, while conference and pipeline news tended to see modest gains.

Recent Company History

Over the last six months, MannKind news has covered earnings, capital structure, conferences, and pipeline data. On Feb 26, 2026, strong Q4 and full-year 2025 revenue growth and multiple upcoming PDUFA dates coincided with a -7.43% move. Settlement of $36.3M in convertible notes announced on Mar 5, 2026 saw a -7.77% reaction. In contrast, Afrezza data presentations on Mar 9, 2026 and the Q1 2026 earnings date announcement on Apr 29, 2026 produced modest positive moves. Today’s collaboration expansion on ralinepag DPI fits the ongoing strategy of inhaled therapeutics partnerships.

Key Terms

dry powder inhalation (dpi), pulmonary arterial hypertension (pah), pulmonary hypertension associated with interstitial lung disease (ph-ild), idiopathic pulmonary fibrosis (ipf), +4 more

8 terms

dry powder inhalation (dpi) medical

"developing a dry powder inhalation (DPI) formulation of ralinepag"

Dry powder inhalation (DPI) is a way of delivering medicines to the lungs using a handheld device that releases a fine, dry powder when the patient breathes in. Investors care because the delivery method affects how well a drug works, how easy it is for patients to use, regulatory approval hurdles, manufacturing complexity, and competitive differentiation — think of it like different packaging designs that change how reliably a product reaches the customer.

pulmonary arterial hypertension (pah) medical

"pivotal phase 3 ADVANCE OUTCOMES study of ralinepag ... in pulmonary arterial hypertension (PAH)"

Pulmonary arterial hypertension (PAH) is a progressive condition where the blood vessels that carry blood from the heart to the lungs become narrowed or stiff, causing high pressure and extra strain on the heart. For investors it matters because PAH creates long-term demand for medical care and specialized drugs; advances, trial results, or regulatory approvals can meaningfully change treatment costs, hospital use, and the commercial prospects for therapies — like fixing a clogged hose to relieve an overworked pump.

pulmonary hypertension associated with interstitial lung disease (ph-ild) medical

"develop the product for pulmonary hypertension associated with interstitial lung disease (PH-ILD)"

Pulmonary hypertension associated with interstitial lung disease (PH-ILD) is high blood pressure in the vessels that supply the lungs, arising as a complication of scarring or inflammation of lung tissue. Think of the lungs as a sponge with tiny pipes: when the sponge becomes stiff or scarred, the pipes must work harder and can narrow, which makes breathing and activity harder; for investors, PH-ILD matters because it creates a clear medical need that drives demand for diagnostics, therapies, clinical trials, regulatory decisions, and long-term healthcare costs.

idiopathic pulmonary fibrosis (ipf) medical

"additional clinical studies assessing safety and efficacy in patients with ... idiopathic pulmonary fibrosis (IPF)"

A chronic lung disease in which the tissue of the lungs gradually becomes scarred and stiff, making it harder to breathe and get enough oxygen. For investors, IPF matters because it drives demand for treatments, shapes the commercial opportunity and clinical trial risk for drug developers, and can influence a company’s regulatory milestones and long‑term revenue potential; think of it as a market shaped by urgent medical need and high development risk.

progressive pulmonary fibrosis (ppf) medical

"plans to develop the product for ... progressive pulmonary fibrosis (PPF)"

Progressive pulmonary fibrosis (PPF) is a chronic lung condition where healthy lung tissue is gradually replaced by stiff, scarred tissue, making it harder to breathe and reducing oxygen uptake. For investors, PPF matters because it creates a clear and growing need for effective therapies, influences the size and urgency of drug and device markets, affects clinical trial design and regulatory risk, and can drive long-term healthcare spending—think of it as a slow, spreading rust that increases repair costs and demand for better fixes.

phase 3 medical

"long-term pivotal phase 3 ADVANCE OUTCOMES study of ralinepag extended-release tablets"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1 study medical

"a subsequent phase 1 study in healthy volunteers to assess dosing"

A phase 1 study is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, side effects and the right dose rather than proving effectiveness. Think of it as a short, closely monitored test drive that checks how the body tolerates the treatment and how it behaves inside the body; results matter to investors because positive safety and dosing data are needed before larger, more value-driving trials can begin.

pharmacokinetic medical

"assess dosing and pharmacokinetic comparability with oral ralinepag tablets"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• The formulation is being developed in collaboration with United Therapeutics Corporation 
• United Therapeutics made an additional $5 million payment to MannKind to support the rapid advancement of ralinepag DPI
• United Therapeutics plans to be the primary manufacturer of ralinepag DPI
• MannKind eligible to receive up to $35 million in development milestones plus 10% royalties on net sales
  
  

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products, today announced that it has been developing a dry powder inhalation (DPI) formulation of ralinepag, known as ralinepag DPI (MNKD-1501), for United Therapeutics Corporation (Nasdaq: UTHR), under the companies’ expanded license and collaboration agreement announcement from August 2025.

Ralinepag is an investigational prostacyclin receptor agonist that exhibits a long half-life and high potency in the pulmonary vasculature. In March 2026, United Therapeutics reported that its long-term pivotal phase 3 ADVANCE OUTCOMES study of ralinepag extended-release tablets in pulmonary arterial hypertension (PAH) met its primary endpoint with high statistical significance.

“Supported by the strength of the pivotal ADVANCE OUTCOMES results, we believe ralinepag has the potential to redefine the PAH treatment landscape, and we view ralinepag DPI as an important component of long-term success to help broaden real-world use and support patients over time,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics.

United Therapeutics believes the half-life of ralinepag may support once-daily dosing of ralinepag DPI. The companies are currently in the process of formulating ralinepag DPI for United Therapeutics’ planned non-clinical studies and a subsequent phase 1 study in healthy volunteers to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, which will then inform a pivotal study in PAH patients to further assess safety and PK comparability. United Therapeutics initially intends to seek approval of ralinepag DPI for PAH. The company also plans to develop the product for pulmonary hypertension associated with interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), and progressive pulmonary fibrosis (PPF), which will require additional clinical studies assessing safety and efficacy in patients with these conditions. Ralinepag is currently not approved in any jurisdiction to treat any of these conditions, in any formulation.

“We have been working on the ralinepag DPI formulation for the past six months and are excited to finally be able to share this announcement,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are pleased to apply our dry powder development expertise to advance ralinepag DPI. This program further validates MannKind’s role as a partner of choice for inhaled delivery of complex and high-value therapeutics.”

Financial Terms and Collaboration Structure
Ralinepag DPI (MNKD-1501) is being advanced under the companies’ existing worldwide collaboration agreement, pursuant to which United Therapeutics leads global development, regulatory, and commercialization activities and MannKind supports formulation and supply activities. United Therapeutics made an additional $5 million payment to MannKind in April 2026, to support the rapid advancement of ralinepag DPI. MannKind is eligible to receive up to $35 million in development milestone payments and 10% royalties on net sales of any resulting commercial product.

The original 2018 agreement with United Therapeutics led to the successful development and FDA approval of Tyvaso DPI^® in May 2022. In 2025, United Therapeutics reported that Tyvaso DPI generated revenue of $1.3B.

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com and follow us on LinkedIn, Facebook, Instagram, and X.

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, 2025 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.

MANNKIND is a registered trademark of MannKind Corporation.

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(617) 921-5461
ir@mnkd.com

FAQ

What did MannKind (MNKD) announce about ralinepag DPI on May 6, 2026?

MannKind announced development of ralinepag DPI (MNKD-1501) in collaboration with United Therapeutics. According to MannKind, United Therapeutics made a $5 million payment and will lead manufacturing, development, and commercialization activities.

How much funding and milestone payments will MannKind (MNKD) receive for the ralinepag DPI program?

MannKind received an additional $5 million payment and is eligible for up to $35 million in development milestones. According to MannKind, the agreement also provides 10% royalties on net sales of any commercial product.

What clinical steps are planned for ralinepag DPI (MNKD-1501) under the collaboration?

The companies plan non-clinical work followed by a phase 1 healthy volunteer study to assess dosing and PK comparability. According to MannKind, results will inform a pivotal PAH study and additional studies for PH-ILD, IPF, and PPF.

Will United Therapeutics manufacture ralinepag DPI for MannKind (MNKD)?

Yes. United Therapeutics intends to be the primary manufacturer of ralinepag DPI. According to MannKind, United Therapeutics will lead global development, regulatory, and commercialization while MannKind supports formulation and supply.

Does ralinepag have existing clinical evidence supporting inhaled development for PAH?

United Therapeutics reported its oral ralinepag extended-release tablet met the ADVANCE OUTCOMES primary endpoint in March 2026. According to MannKind, that pivotal result supports pursuing a once-daily ralinepag DPI program for PAH and other pulmonary conditions.