MannKind Collaborates with United Therapeutics on Ralinepag DPI Development
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 37 minutes ago
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Should l Buy UTHR?
Source: Globenewswire
- Collaboration Expansion: MannKind is developing a dry powder inhalation (DPI) formulation of ralinepag under an expanded licensing agreement with United Therapeutics from 2025, aiming to enhance treatment options for pulmonary arterial hypertension (PAH), which could significantly improve patient outcomes.
- Financial Backing: United Therapeutics made a $5 million payment to MannKind in April 2026 to expedite the development of ralinepag DPI, with MannKind eligible for up to $35 million in milestone payments and 10% royalties on net sales, thereby strengthening its financial position.
- Clinical Research Plans: MannKind is currently formulating ralinepag DPI for non-clinical studies and plans to conduct a phase 1 study in healthy volunteers to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, which will inform pivotal studies in PAH patients.
- Market Potential: The long half-life of ralinepag may support once-daily dosing, and United Therapeutics plans to develop the product for pulmonary hypertension associated with interstitial lung disease, indicating broad future market applications for this therapy.
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Analyst Views on UTHR
Wall Street analysts forecast UTHR stock price to fall
8 Analyst Rating
5 Buy
3 Hold
0 Sell
Moderate Buy
Current: 581.220
Low
423.00
Averages
534.50
High
645.00
Current: 581.220
Low
423.00
Averages
534.50
High
645.00
About UTHR
United Therapeutics Corporation is a pharmaceutical company. The Company markets and sells commercial therapies to treat pulmonary arterial hypertension (PAH): Tyvaso DPI (treprostinil) Inhalation Powder (Tyvaso DPI); Tyvaso (treprostinil) Inhalation Solution (nebulized Tyvaso), which includes the Tyvaso Inhalation System; Remodulin (treprostinil) Injection (Remodulin); Orenitram (treprostinil) Extended-Release Tablets (Orenitram); and Adcirca (tadalafil) Tablets (Adcirca). Tyvaso DPI and nebulized Tyvaso are also approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). It also markets and sells an oncology product, Unituxin (dinutuximab) Injection for the treatment of high-risk neuroblastoma, and the Remunity Pump for Remodulin. Tyvaso DPI is a drug-device combination product that incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza (insulin human) Inhalation Powder product.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Earnings Expectations: The consensus EPS estimate stands at $7.04, with revenue expectations at $797.38 million, reflecting a modest 0.4% year-over-year growth, indicating market confidence in the company's stable growth trajectory.
- Estimate Revisions: Over the past three months, EPS estimates have seen no upward revisions and four downward adjustments, while revenue estimates experienced one upward revision and five downward adjustments, highlighting analysts' differing views on the company's future performance.
- Market Reaction: United Therapeutics' stock surged recently due to positive results from Tyvaso for idiopathic pulmonary fibrosis, demonstrating strong market recognition of its product efficacy.
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- Market Reaction: The disappointing earnings report may lead investors to reassess their investment strategies regarding United Therapeutics, resulting in increased stock price volatility and affecting the company's performance in the capital markets.
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MannKind Collaborates with United Therapeutics on Ralinepag DPI Development
- Collaboration Expansion: MannKind is developing a dry powder inhalation (DPI) formulation of ralinepag under an expanded licensing agreement with United Therapeutics from 2025, aiming to enhance treatment options for pulmonary arterial hypertension (PAH), which could significantly improve patient outcomes.
- Financial Backing: United Therapeutics made a $5 million payment to MannKind in April 2026 to expedite the development of ralinepag DPI, with MannKind eligible for up to $35 million in milestone payments and 10% royalties on net sales, thereby strengthening its financial position.
- Clinical Research Plans: MannKind is currently formulating ralinepag DPI for non-clinical studies and plans to conduct a phase 1 study in healthy volunteers to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, which will inform pivotal studies in PAH patients.
- Market Potential: The long half-life of ralinepag may support once-daily dosing, and United Therapeutics plans to develop the product for pulmonary hypertension associated with interstitial lung disease, indicating broad future market applications for this therapy.
See More
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- Market Potential: MannKind is eligible to receive up to $35 million in development milestone payments and 10% royalties on net sales, which not only provides a substantial revenue stream for the company but also indicates strong market demand and confidence in the product.
- Clinical Research Plans: Currently, non-clinical studies and a subsequent phase 1 study in healthy volunteers are underway to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, laying the groundwork for pivotal studies in PAH patients.
- Strategic Collaboration: This partnership is based on a global collaboration agreement established in 2018, where United Therapeutics leads global development and commercialization activities while MannKind focuses on formulation and supply, facilitating success in the complex drug delivery space.
See More
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- R&D Expense Changes: Research and development expenses totaled $138.2 million, a 7% decrease compared to the previous year, mainly due to reduced milestone payments, although internal R&D spending increased, indicating ongoing commitment to innovation.
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- Earnings Announcement: United Therapeutics is scheduled to release its Q1 2023 earnings report on May 6 before the market opens, drawing significant attention from investors regarding its performance.
- Earnings Expectations: The consensus EPS estimate stands at $7.04, with revenue expectations at $797.38 million, reflecting a modest 0.4% year-over-year growth, indicating market confidence in the company's stable growth trajectory.
- Estimate Revisions: Over the past three months, EPS estimates have seen no upward revisions and four downward adjustments, while revenue estimates experienced one upward revision and five downward adjustments, highlighting analysts' differing views on the company's future performance.
- Market Reaction: United Therapeutics' stock surged recently due to positive results from Tyvaso for idiopathic pulmonary fibrosis, demonstrating strong market recognition of its product efficacy.
See More
United Therapeutics Q1 Earnings Miss Expectations
- Earnings Performance: United Therapeutics reported a Q1 GAAP EPS of $5.82, missing expectations by $1.04, indicating a decline in profitability that may affect investor confidence.
- Revenue Decline: The company generated $781.5 million in revenue for Q1, a 1.6% year-over-year decrease that fell short of projections, reflecting weak market demand and potentially impacting future growth prospects.
- Market Reaction: The disappointing earnings report may lead investors to reassess their investment strategies regarding United Therapeutics, resulting in increased stock price volatility and affecting the company's performance in the capital markets.
- Future Outlook: Despite the current earnings miss, the company's prospects in the manufactured organs sector remain promising, and successful advancement of related projects could provide momentum for future performance recovery.
See More
MannKind Collaborates with United Therapeutics on Ralinepag DPI Development
- Collaboration Expansion: MannKind is developing a dry powder inhalation (DPI) formulation of ralinepag under an expanded licensing agreement with United Therapeutics from 2025, aiming to enhance treatment options for pulmonary arterial hypertension (PAH), which could significantly improve patient outcomes.
- Financial Backing: United Therapeutics made a $5 million payment to MannKind in April 2026 to expedite the development of ralinepag DPI, with MannKind eligible for up to $35 million in milestone payments and 10% royalties on net sales, thereby strengthening its financial position.
- Clinical Research Plans: MannKind is currently formulating ralinepag DPI for non-clinical studies and plans to conduct a phase 1 study in healthy volunteers to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, which will inform pivotal studies in PAH patients.
- Market Potential: The long half-life of ralinepag may support once-daily dosing, and United Therapeutics plans to develop the product for pulmonary hypertension associated with interstitial lung disease, indicating broad future market applications for this therapy.
See More
MannKind Partners with United Therapeutics to Advance Ralinepag DPI
- Funding Support: United Therapeutics made a $5 million payment to MannKind in April 2026 to accelerate the development of ralinepag DPI, which will significantly enhance the project's advancement speed and ensure the product enters clinical stages promptly.
- Market Potential: MannKind is eligible to receive up to $35 million in development milestone payments and 10% royalties on net sales, which not only provides a substantial revenue stream for the company but also indicates strong market demand and confidence in the product.
- Clinical Research Plans: Currently, non-clinical studies and a subsequent phase 1 study in healthy volunteers are underway to assess dosing and pharmacokinetic comparability with oral ralinepag tablets, laying the groundwork for pivotal studies in PAH patients.
- Strategic Collaboration: This partnership is based on a global collaboration agreement established in 2018, where United Therapeutics leads global development and commercialization activities while MannKind focuses on formulation and supply, facilitating success in the complex drug delivery space.
See More
United Therapeutics Reports Q1 2026 Financial Results
- Revenue Decline: Total revenues for Q1 2026 were $781.5 million, a 2% year-over-year decrease primarily due to reduced Nebulized Tyvaso sales, although Tyvaso DPI revenues grew by 9%.
- Net Income Drop: Net income stood at $274.9 million, down 15% year-over-year, with earnings per share at $6.32, reflecting pressures from rising costs and sales fluctuations.
- R&D Expense Changes: Research and development expenses totaled $138.2 million, a 7% decrease compared to the previous year, mainly due to reduced milestone payments, although internal R&D spending increased, indicating ongoing commitment to innovation.
- Share Repurchase Plan: The company's board approved a $2.0 billion share repurchase program and entered into agreements with Citibank to repurchase approximately $1.5 billion of common stock, aimed at enhancing shareholder value and boosting market confidence.
See More
United Therapeutics (UTHR.US) Officer Plans to Sell $108.56 Million in Common Stock via Form 144
Stock Sale Announcement: Martin Rothblatt intends to sell 190,000 shares of United Therapeutics (UTHR) common stock on May 1, with a total market value of approximately $108.56 million.
Reduction in Shareholding: Rothblatt has reduced his shareholding in United Therapeutics by 408,580 shares since March 2, 2026, with a total value of around $224.88 million.
See More
