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2026-07-24 18:10 1d ago
2026-07-24 12:00 1d ago
Liquidia hlásí třetí ziskové čtvrtletí díky Yutrepia
UTHR United Therapeutics
FMP Stock News 72
Original source text
Key Takeaways Liquidia's Yutrepia launch has driven strong sales, adoption and three straight profitable quarters. LQDA projects far faster 2026 revenue and EPS growth, backed by rising earnings estimates.United Therapeutics counters with a broad PAH portfolio and late-stage ralinepag pipeline. Liquidia Corporation (LQDA - Free Report) is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

United Therapeutics (UTHR - Free Report) boasts six FDA-approved therapies that treat PAH, PH-ILD, and neuroblastoma, a rare pediatric cancer, in its portfolio.

Liquidia and United Therapeutics are locked in a fierce battle in the PAH market, with Liquidia's Yutrepia emerging as a challenger to United Therapeutics' blockbuster Tyvaso franchise. Their competition extends beyond commercial sales to patent disputes and a race to capture a larger share of the inhaled treprostinil market.

Given this backdrop, selecting one stock over the other can be difficult. We therefore evaluate their fundamentals, growth prospects, challenges and valuation metrics to help make an informed decision.

The Case for LQDALiquidia currently markets Yutrepia (treprostinil) inhalation powder, approved by the FDA in May 2025 and launched the following month commercially.

The company also generates revenues through a profit-sharing agreement with Sandoz for the promotion of its generic treprostinil injection in the United States.

Yutrepia is an inhaled dry-powder formulation of treprostinil developed using Liquidia's proprietary PRINT particle engineering technology. The platform is designed to enhance deep lung drug delivery, simplify administration through a low-effort dry-powder inhaler and enable higher dose levels than currently marketed inhaled treprostinil therapies.

The company supports commercialization through a specialized sales force focused on physicians treating PAH and PH-ILD, as well as stakeholders involved in reimbursement and drug distribution.

Since its launch in June 2025, Yutrepia has emerged as a strong growth driver, generating approximately $130 million in first-quarter 2026 sales. The therapy has demonstrated robust adoption, with more than 4,500 unique prescriptions, around 3,750 patients initiating treatment, and nearly 1,000 physicians prescribing the drug.

Its rapid uptake helped Liquidia post its third consecutive profitable quarter, highlighting Yutrepia's growing commercial success.

Beyond its commercial portfolio, Liquidia is advancing a pipeline of therapies for pulmonary vascular diseases. Its lead pipeline candidate, L606, is an investigational liposomal formulation of treprostinil administered twice daily via a next-generation nebulizer. L606 is being evaluated in an open-label study for PAH and PH-ILD, while a global pivotal placebo-controlled trial is underway in PH-ILD.

Liquidia also plans to expand Yutrepia into additional indications, including pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF) and Raynaud's phenomenon associated with systemic sclerosis.

The Case for UTHRUnited Therapeutics markets a broad PAH portfolio led by Tyvaso DPI, a dry-powder inhaled formulation of the prostacyclin analogue treprostinil, which was approved by FDA in May 2022 to improve exercise ability in patients with PAH and PH-ILD.

Its portfolio includes nebulized Tyvaso, a nebulized liquid inhaled formulation of treprostinil, approved by the FDA to improve exercise ability in patients with PAH and PH-ILD.

The company also markets Remodulin, a continuously infused treprostinil therapy for PAH administered subcutaneously or intravenously, supported by the user-friendly RemunityPRO infusion pump. Its PAH portfolio further includes Orenitram, an oral extended-release treprostinil tablet, and Adcirca (tadalafil), an oral PDE-5 inhibitor licensed from Eli Lilly through the end of 2026.

Sales of Tyvaso products continue to grow, driven by higher volumes and continued growth in commercialization utilization. Moreover, Orenitram offers a convenient oral treatment option that avoids the challenges associated with continuous infusion therapies, such as Remodulin, and inhaled therapies requiring multiple daily administrations.

The company remains focused on developing additional therapies for PAH and pulmonary fibrosis (PF).

Ralinepag, an investigational, highly selective and potent prostacyclin (IP) receptor, is one of United Therapeutics' most promising late-stage pipeline assets. The candidate is being developed in two formulations — an oral version and a DPI version (RAL-DPI).

Based on positive data from the pivotal phase III ADVANCE OUTCOMES study, United Therapeutics intends to submit a new drug application for ralinepag (to treat PAH) to the FDA by the second half of 2026.

If approved, oral ralinepag could strengthen United Therapeutics’ leadership in PAH and potentially offset future competitive pressure on older products.

Beyond the oral formulation, United Therapeutics is also developing inhaled dry-powder versions of ralinepag, RAL-DPI, in collaboration with MannKind Corporation. While initially targeting PAH, management sees opportunities for RAL-DPI in PH-ILD, IPF and PPF. Together, the oral and inhaled formulations position ralinepag as a potential cornerstone of United Therapeutics' future growth strategy.

Outside its PAH franchise, the company markets Unituxin for the treatment of high-risk neuroblastoma.

UTHR strengthened its long-term regenerative medicine strategy by acquiring preclinical stage biotech Thymmune Therapeutics for $140 million upfront, with up to $160 million in milestone payments. The deal adds THY-100, a stem cell-derived thymic cell therapy being developed for congenital athymia, and a platform with potential applications in organ transplantation, autoimmune diseases and immune deficiencies.  The acquisition broadens United Therapeutics' pipeline beyond PAH.

A Look at Estimates: LQDA versus UTHRThe Zacks Consensus Estimate for LQDA’s 2026 sales implies a year-over-year increase of 315.77%, while that for earnings per share (EPS) suggests a year-over-year improvement of 477.5%. The Zacks Consensus Estimate for 2026 EPS has moved north to $3.02 from $2.97 and that for 2027 EPS has increased to $4.92 from $4.81 in the past 60 days.

LQDA’s Estimate Movement
Image Source: Zacks Investment Research

The Zacks Consensus Estimate for UTHR’s 2026 sales implies a year-over-year increase of 1.46%, while that for EPS suggests a year-over-year decline of 4.41%.  EPS estimates for 2026 have moved south to $26.63 in the past 60 days but those for 2026 have moved north to $31.66 from $31.09 during the said time frame.

UTHR’s Estimate Movement
Image Source: Zacks Investment Research

Price Performance and Valuation of LQDA and UTHRFrom a price-performance perspective, LQDA has fetched better returns than UTHR so far in the year. Shares of LQDA have surged 158.2%, while those of UTHR have gained 8.7%. The industry has gained 1.4% in the said period.

Image Source: Zacks Investment Research

From a valuation standpoint, LQDA is more expensive than UTHR. LQDA’s shares currently trade at 8.74X forward sales, higher than 6.50X for UTHR.

Image Source: Zacks Investment Research

Which Stock Is a Better Pick for Now?LQDA currently sports a Zacks Rank #1 (Strong Buy), while UTHR carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Although United Therapeutics remains the established leader in PAH with a diversified portfolio, a robust late-stage pipeline and expansion into regenerative medicine, much of its growth appears incremental.

In contrast, Liquidia is in the early stages of a rapid commercial expansion, driven by the impressive launch of Yutrepia, expanding label opportunities and a promising pipeline. The company's superior revenue and earnings growth outlook, upward estimate revisions, stronger year-to-date share price performance and better Zacks Rank outweigh its premium valuation.

While UTHR remains a solid long-term holding, Liquidia offers the more compelling growth story and greater upside potential at current levels, making LQDA the better pick for investors seeking higher returns.
2026-07-09 20:25 16d ago
2026-07-09 15:30 16d ago
United Therapeutics oznamuje pozitivní výsledky Tyvaso ve fázi III
UTHR United Therapeutics
FMP Stock News 78
Original source text
Key Takeaways UTHR reported positive phase III results for Tyvaso in IPF, supporting a planned FDA supplemental filing.UTHR plans an FDA filing for ralinepag after phase III success & targets $4B annual revenue run rate by 2027.UTHR is advancing organ manufacturing while facing growing competition for its core PAH therapies. Shares of United Therapeutics (UTHR - Free Report) have gained 14% year to date against the industry’s 0.8% decline, driven by major clinical breakthroughs and improved long-term growth visibility that have significantly strengthened investor confidence.

Image Source: Zacks Investment Research

UTHR’s Meaningful Pipeline Expansion Encourages InvestorsInvestor sentiment has been boosted by encouraging progress across United Therapeutics' pipeline.

The company is expanding nebulized Tyvaso beyond its approved pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications into larger pulmonary fibrosis markets such as idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The company's IPF development program consists of two pivotal phase III studies, TETON-1 and TETON-2. The studies share a similar design, differing primarily in their geographic scope. TETON-1 was conducted at sites across the United States and Canada, while TETON-2 enrolled patients at sites outside these countries.

In March 2026, the company announced positive results from the late-stage TETON-1 study, which achieved its primary endpoint by demonstrating a statistically significant improvement in lung function for patients with IPF. The magnitude of benefit observed in TETON-1 exceeded the already strong outcomes previously reported in TETON-2, representing a significant advancement for patients with IPF.

Positive phase III data from both the TETON-1 and TETON-2 studies support a planned FDA supplemental application for Tyvaso in IPF. Management believes the IPF opportunity alone could eventually surpass Tyvaso's current PAH revenues. It is also enrolling patients in the phase III TETON PPF study evaluating the drug in patients with PPF.

The company's late-stage PAH candidate ralinepag delivered positive phase III data from the ADVANCE OUTCOMES study in March. The study met its primary and secondary endpoints. UTHR intends to submit a new drug application for ralinepag to the FDA in the second half of 2026. 

The company is developing an inhaled dry-powder version of ralinepag (RAL-DPI) in collaboration with MannKind Corporation. While initially targeting PAH, management sees potential opportunities for RAL-DPI in PH-ILD, IPF and PPF.

Together, Tyvaso's label expansion and the ralinepag franchise are expected to drive long-term growth, supporting the company's goal of increasing its annual revenue run rate from $3 billion to $4 billion by the end of 2027 and boosting investor sentiment.

Organ Manufacturing Business on MoveUnited Therapeutics continues to strengthen its long-term growth outlook through steady progress in its organ manufacturing platform, which spans hearts, kidneys, livers and lungs. The company is advancing multiple technologies, including xenotransplantation, regenerative medicine, bioengineered organs, 3D bioprinting and ex-vivo lung perfusion (EVLP) to address the global shortage of donor organs.

Its xenotransplantation portfolio includes development-stage candidates UKidney, UHeart and UThymoKidney. The FDA cleared the investigational new drug application for the phase I EXPRESS study evaluating UHeart in May. United Therapeutics received FDA premarket approval for LungFX, the first EVLP device for assessing donor lungs outside the body, with a commercial launch planned for 2027.

Earlier this month, the acquisition of Thymmune Therapeutics expanded the company's regenerative medicine portfolio with the preclinical thymic cell therapy THY-100, strengthening its long-term strategy to improve organ transplantation and immune restoration.

UTHR Faces Competitive PressureUnited Therapeutics generates most of its revenues from its treprostinil-based PAH therapies, including Tyvaso, Orenitram, Adcirca and Remodulin. The company markets two versions of Tyvaso: Tyvaso dry powder inhalation (DPI) and nebulized Tyvaso. The drug remains the company's biggest growth driver, with the more convenient Tyvaso DPI continuing to gain traction and posting 9% year-over-year sales growth in the first quarter of 2026.

A key concern for United Therapeutics is the increasing competitive pressure on its core PAH franchise. While Tyvaso DPI continues to grow, sales of nebulized Tyvaso have been declining due to market erosion following the loss of exclusivity in May 2025 and the FDA approval of Liquidia Corporation’s (LQDA - Free Report) Yutrepia, the first inhaled dry-powder competitor for PAH and PH-ILD. Yutrepia's rapid market adoption, with 44% sequential sales growth in the first quarter of 2026, underscores the growing competitive threat to Tyvaso products.

UTHR’s heavy reliance on the PAH market remains a risk as its established therapies face rising competition from generics and newer treatments. With limited diversification beyond PAH, United Therapeutics' long-term growth depends largely on the successful development and commercialization of its pipeline, making any clinical, regulatory or commercialization setbacks a potential headwind for the stock.

UTHR's Zacks Rank & Stocks to ConsiderUnited Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) and Amarin Corporation (AMRN - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.47. Over the same period, EPS estimates for 2027 have risen from $10.23 to $10.79. NBIX shares have lost 25.6% year to date.

Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.

Over the past 60 days, loss per share estimates for Amarin Corporation have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 8.5% year to date.

Amarin Corporation’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
2026-07-02 11:07 23d ago
2026-07-02 06:30 23d ago
United Therapeutics koupila Thymmune za 140 milionů USD
UTHR United Therapeutics
FMP Stock News 86
Original source text
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR) announced today it has acquired Thymmune Therapeutics, Inc. (Thymmune), a privately held, preclinical stage biotechnology company developing scalable, regenerative thymic cell therapies for the potential treatment of post-transplant organ tolerance, immunodeficiencies, and autoimmune diseases.

The thymus is a critical organ for the development and proper function of key parts of the immune system, including training T-cells, which are essential for fighting infections and other diseases. Thymmune has a proprietary process for converting human-induced pluripotent stem cells (iPSC) into thymic cells, which — once inside the body — mature into cell types that can restore healthy T-cell function.

Thymmune’s lead candidate, THY-100, is in preclinical development for congenital athymia, an ultra-rare and life-threatening condition in which infants are born without a functional thymus. Animal studies have shown that treatment with THY-100 results in the in vivo formation of a neo-thymus that is capable of facilitating T-cell development. The clinical proof of concept and further development of THY-100 has the potential to broaden thymic regenerative medicine approaches for transplant tolerance, serious immune-mediated diseases, and enhanced longevity for older adults with diminished T-cell function.

“Thymmune’s platform complements United Therapeutics’ broader mission to expand the supply of transplantable organs, building on our UThymoKidney™ clinical development program and our growing strength in immunomodulatory therapeutics,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “By restoring or modulating T-cell receptor diversity, Thymmune’s technology could make fundamental contributions to human health care and potentially resolve the root causes of dozens of life-threatening diseases.”

“Thymmune was founded to harness the biology of the thymus to restore immune function for patients with serious immune-mediated diseases,” said Stan Wang, M.D., Ph.D., Chief Executive Officer and Founder of Thymmune Therapeutics. “United Therapeutics shares our conviction that regenerative medicine can transform the lives of patients, and we believe its leadership in organ alternatives and cell-based technologies makes it the ideal partner to advance our platform toward broad clinical impact.”

Under the terms of the agreement, United Therapeutics acquired Thymmune for $140 million in cash, subject to certain post-closing adjustments, plus potential earn-out payments to former Thymmune equityholders of up to $160 million based upon the achievement of certain clinical and regulatory milestones by the end of 2031.

About United Therapeutics

Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding our plans to develop THY-100 and other products based on Thymmune’s technology, including the potential to broaden thymic regenerative medicine approaches for transplant tolerance, serious immune-mediated diseases, and enhanced longevity for older adults with diminished T-cell function, the potential for Thymmune’s technology to support our organ manufacturing programs, the potential for Thymmune’s technology to make fundamental contributions to human health care and potentially resolve the root causes of dozens of life-threatening diseases, the potential earn-out payments to the former Thymmune stockholders, our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 2, 2026, and assume no obligation to update or revise the information contained in this press release whether because of new information, future events, or any other reason.

UTHYMOKIDNEY is a trademark of United Therapeutics Corporation.