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FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH
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Key Takeaways
United Therapeutics' ralinepag NDA was accepted by the FDA, with a decision expected on June 24, 2027.
Ralinepag cut clinical worsening risk by 55% versus placebo and improved key secondary endpoints.
The once-daily oral therapy also improved six-minute walk distance and NT-proBNP levels in PAH patients.
United Therapeutics (UTHR - Free Report) announced that the FDA has accepted the new drug application (NDA) seeking approval for its investigational drug, ralinepag, a once-daily oral prostacyclin receptor agonist for treating pulmonary arterial hypertension (PAH). A decision from the regulatory body is expected on June 24, 2027.
PAH is a rare and life-threatening condition marked by high blood pressure in the lung arteries, which can strain the heart and eventually cause heart failure. It affects about 500,000 people worldwide, including 50,000 in the United States, while many cases remain undiagnosed or untreated.
Year to date, shares of United Therapeutics have risen 8.3% compared with the industry’s 2.3% growth.
Image Source: Zacks Investment Research
Ralinepag NDA Backed by UTHR’s Positive Phase III Data
United Therapeutics submitted the NDA for oral ralinepag in PAH indications to the FDA in June. The filing was based on positive data from the phase III ADVANCE OUTCOMES study. The study met its primary endpoints by demonstrating that treatment with ralinepag reduced the risk of clinical worsening by 55% versus placebo and showed durable efficacy in delaying disease progression in patients with PAH. Statistically significant improvements were observed across key secondary endpoints such as six-minute walk distance and changes in N-terminal pro-B-type natriuretic peptide levels.
If approved, ralinepag would become the first and only once-daily oral prostacyclin approved by the FDA for PAH. UTHR’s convenient dosing could provide an attractive option for patients while helping the company address competitive pressures facing its existing PAH portfolio.
UTHR’s Established PAH Franchise Provides Strong Foundation
United Therapeutics has an established presence in the PAH market, with four marketed therapies: Tyvaso, Orenitram, Adcirca and Remodulin. Tyvaso products are among the key contributors to the company’s revenues. The company markets Tyvaso in two formulations, Tyvaso DPI and nebulized Tyvaso. Both are approved for PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The company is advancing Tresmi, an investigational inhaled treprostinil solution delivered via a soft mist inhaler for the treatment of PAH and PH-ILD. The therapy is designed to reduce coughing by up to 90% compared with Tyvaso DPI. UTHR plans to submit regulatory applications for PAH and PH-ILD in 2026, with a commercial launch in 2027, subject to regulatory approval.
Ralinepag DPI Adds Further Growth Potential
Beyond the oral formulation, United Therapeutics is developing an inhaled dry-powder version of ralinepag, ralinepag DPI (RAL-DPI), in collaboration with MannKind Corporation (MNKD - Free Report) . While initially targeting PAH, management sees potential opportunities for RAL-DPI in PH-ILD, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. At present, the candidate is in an early-stage of development. The company plans to file an investigational new drug application later this year.
UTHR's Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, estimates for Precigen’s 2026 loss per share have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 72% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 13.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
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FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH
Key Takeaways
United Therapeutics (UTHR - Free Report) announced that the FDA has accepted the new drug application (NDA) seeking approval for its investigational drug, ralinepag, a once-daily oral prostacyclin receptor agonist for treating pulmonary arterial hypertension (PAH). A decision from the regulatory body is expected on June 24, 2027.
PAH is a rare and life-threatening condition marked by high blood pressure in the lung arteries, which can strain the heart and eventually cause heart failure. It affects about 500,000 people worldwide, including 50,000 in the United States, while many cases remain undiagnosed or untreated.
Year to date, shares of United Therapeutics have risen 8.3% compared with the industry’s 2.3% growth.
Image Source: Zacks Investment Research
Ralinepag NDA Backed by UTHR’s Positive Phase III Data
United Therapeutics submitted the NDA for oral ralinepag in PAH indications to the FDA in June. The filing was based on positive data from the phase III ADVANCE OUTCOMES study. The study met its primary endpoints by demonstrating that treatment with ralinepag reduced the risk of clinical worsening by 55% versus placebo and showed durable efficacy in delaying disease progression in patients with PAH. Statistically significant improvements were observed across key secondary endpoints such as six-minute walk distance and changes in N-terminal pro-B-type natriuretic peptide levels.
If approved, ralinepag would become the first and only once-daily oral prostacyclin approved by the FDA for PAH. UTHR’s convenient dosing could provide an attractive option for patients while helping the company address competitive pressures facing its existing PAH portfolio.
UTHR’s Established PAH Franchise Provides Strong Foundation
United Therapeutics has an established presence in the PAH market, with four marketed therapies: Tyvaso, Orenitram, Adcirca and Remodulin. Tyvaso products are among the key contributors to the company’s revenues. The company markets Tyvaso in two formulations, Tyvaso DPI and nebulized Tyvaso. Both are approved for PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The company is advancing Tresmi, an investigational inhaled treprostinil solution delivered via a soft mist inhaler for the treatment of PAH and PH-ILD. The therapy is designed to reduce coughing by up to 90% compared with Tyvaso DPI. UTHR plans to submit regulatory applications for PAH and PH-ILD in 2026, with a commercial launch in 2027, subject to regulatory approval.
Ralinepag DPI Adds Further Growth Potential
Beyond the oral formulation, United Therapeutics is developing an inhaled dry-powder version of ralinepag, ralinepag DPI (RAL-DPI), in collaboration with MannKind Corporation (MNKD - Free Report) . While initially targeting PAH, management sees potential opportunities for RAL-DPI in PH-ILD, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. At present, the candidate is in an early-stage of development. The company plans to file an investigational new drug application later this year.
UTHR's Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), while AC Immune (ACIU - Free Report) carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Precigen’s 2026 loss per share have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 72% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 13.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.