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	Saved 2026-09-03 17:27 6d ago Published 2026-09-03 12:46 6d ago	FDA přijala žádost sNDA společnosti United Therapeutics pro Tyvaso v IPF FDA přijala žádost sNDA společnosti United Therapeutics pro Tyvaso v idiopatické plicní fibróze; rozhodnutí se očekává na konci dubna 2027. Data ze studie TETON ukázala zlepšení FVC o 111,8 mL. UTHR United Therapeutics	FMP Stock News	86
Original source text Key Takeaways United Therapeutics' Tyvaso sNDA seeks approval for IPF, with an FDA decision expected in April 2027.TETON studies showed significant FVC gains, reduced clinical worsening and favorable secondary endpoints.Integrated TETON data showed a 111.8 mL FVC benefit, supporting Tyvaso's potential in IPF. United Therapeutics (UTHR - Free Report) recently announced that the FDA has accepted its supplemental new drug application (sNDA) for review, seeking approval for expanded use of its marketed drug, nebulized Tyvaso, in idiopathic pulmonary fibrosis (IPF). A regulatory decision is expected in late April 2027. If approved, the product would be the first FDA-approved inhaled anti-fibrotic treatment for the said indication. United Therapeutics already markets nebulized Tyvaso for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. Besides the nebulized formulation, the drug is also approved as a dry powder inhalation (DPI) version for the same indications. The company generates majority of its revenues from the Tyvaso franchise. IPF is a progressive lung-scarring disease that gradually impairs oxygen transfer, often leading to respiratory failure and death. It primarily affects older adults and may be associated with smoking, genetic factors, environmental exposures and acid reflux. In the United States, at least 100,000 people are estimated to live with IPF, highlighting a significant unmet medical need. Year to date, shares of United Therapeutics have risen 0.9% compared with the industry’s 0.6% growth. Image Source: Zacks Investment Research UTHR’s Tyvaso sNDA for IPF Backed by TETON DataThe sNDA was submitted in June, based on positive top-line data from the TETON program, which consisted of two parallel phase III studies, TETON-1 (conducted in the United States and Canada) and TETON-2 (internationally), designed to evaluate nebulized Tyvaso in patients with IPF. Both studies met their primary endpoints, demonstrating statistically significant improvement in lung function for IPF patients, including a meaningful increase in forced vital capacity (FVC). The studies also reduced the risk of clinical worsening and showed favorable trends across key secondary endpoints. Integrated analyses of studies reinforced these findings, showing a 111.8 mL FVC benefit and broad secondary endpoint improvements. In addition to IPF, United Therapeutics is conducting a late-stage TETON PPF study to evaluate the therapy in progressive pulmonary fibrosis (PPF). The company completed patient enrollment in August, with top-line data anticipated in the second half of 2027. UTHR's Zacks Rank & Stocks to ConsiderUnited 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), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 30 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents per share to earnings of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents per share. PGEN shares have surged 68% 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 per share. ACIU shares have lost 9.6% year to date. AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%. Over the past 30 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.1% year to date. Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
	Saved 2026-08-31 10:19 9d ago Published 2026-08-28 10:25 12d ago	FDA přijala žádost United Therapeutics o schválení ralinepagu pro PAH FDA přijala žádost United Therapeutics o schválení ralinepagu pro PAH; rozhodnutí se očekává 24. června 2027. Léčba v klinické studii snížila riziko zhoršení o 55 % oproti placebu. UTHR United Therapeutics	FMP Stock News	88
Original source text 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 DataUnited 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 FoundationUnited 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 PotentialBeyond 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 ConsiderUnited 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%.
	Saved 2026-08-18 15:47 22d ago Published 2026-08-18 11:41 22d ago	United Therapeutics dokončila nábor do studie Tyvaso United Therapeutics dokončila nábor 754 pacientů do fáze III studie TETON-PPF s Tyvaso pro progresivní plicní fibrózu. Pozitivní výsledky by mohly podpořit podání k FDA o rozšíření indikace. UTHR United Therapeutics	FMP Stock News	78
Original source text Key Takeaways United Therapeutics enrolled 754 PPF patients in the 52-week TETON-PPF Phase III study.The study's primary endpoint is the change in absolute FVC from baseline through week 52.Positive results could support an FDA filing to add PPF to Tyvaso's labeled indications. United Therapeutics (UTHR - Free Report) announced completing enrollment in the phase III TETON-PPF study evaluating Tyvaso (treprostinil) inhalation solution for the treatment of progressive pulmonary fibrosis (PPF). The global registrational study is designed to assess the safety and efficacy of nebulized Tyvaso in this patient population over 52 weeks. Per UTHR, PPF is a progressive form of interstitial lung disease (ILD) marked by worsening lung function and fibrosis, with approximately 200,000 patients estimated to be affected in the United States. United Therapeutics’ Tyvaso is already approved for two indications. It is indicated to improve exercise ability in patients with pulmonary arterial hypertension (PAH; WHO Group 1) and in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). However, its use in PPF remains investigational, and the FDA has not approved nebulized Tyvaso for this indication. UTHR’s Phase III PPF Study Design in DetailUnited Therapeutics’ phase III TETON-PPF placebo-controlled study has enrolled 754 PPF patients who were randomly assigned in a 1:1 ratio to receive either nebulized Tyvaso or placebo. Treatment began at three breaths four times daily and was gradually increased, as tolerated, toward a target of 12 breaths four times daily. The treatment period will run for 52 weeks, with patients who complete the final study visit potentially eligible for an open-label extension. Year to date, shares of United Therapeutics have gained 4.3% against the industry’s 1.1% decline. Image Source: Zacks Investment Research The primary endpoint is the change in absolute forced vital capacity (FVC) from baseline through week 52, which is intended to measure the treatment’s effect on lung function. Secondary endpoints include time to first clinical worsening, time to first acute exacerbation of ILD, overall survival at week 52, change in percent predicted FVC, change in the King’s Brief Interstitial Lung Disease questionnaire score and change in diffusing capacity of the lungs for carbon monoxide. The study is also collecting data on N-terminal pro-brain natriuretic peptide levels and supplemental oxygen use, while safety assessments cover adverse events, laboratory measures, vital signs and electrocardiograms. UTHR’s Next StepsHaving completed enrollment in the phase III study evaluating Tyvaso, United Therapeutics expects to report top-line results in the second half of 2027. The readout will be an important milestone for UTHR, as positive results could expand access to a potential new treatment option for patients with PPF, who currently have limited therapies available and face progressive loss of lung function, poorer quality of life and increased mortality. Subject to the success of the TETON-PPF study, United Therapeutics plans to use the data to support a supplemental new drug application (sNDA) with the FDA to add PPF to the labeled indications for nebulized Tyvaso. Separately, UTHR is already seeking priority review for an sNDA submitted to the FDA in June 2026 to add idiopathic pulmonary fibrosis to the labeled indications for nebulized Tyvaso, based on data from the TETON-1 and TETON-2 studies. Under the FDA’s Priority Review pathway, the agency aims to take action on an eligible marketing application within six months compared with 10 months under standard review. Priority Review is generally granted to applications for drugs that treat serious conditions and, if approved, would provide a significant improvement in the safety or effectiveness of treatment, diagnosis or prevention. UTHR’s Zacks Rank & Stocks to ConsiderUnited Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals (AMRX - Free Report) , Repligen (RGEN - Free Report) and AC Immune (ACIU - Free Report) . AMRX and RGEN currently sport a Zacks Rank #1 (Strong Buy) each, while ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 46.1% year to date. Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61. RGEN shares have gained 3.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 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 plunged 19.4% year to date. AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
	Saved 2026-08-05 17:11 1mo ago Published 2026-08-05 12:30 1mo ago	United Therapeutics zahájila konferenční hovor k výsledkům za 2. čtvrtletí United Therapeutics uspořádala konferenční hovor k výsledkům za 2. čtvrtletí 2026. V úvodu zaznělo jen upozornění na rizika a forward-looking statements. UTHR United Therapeutics	FMP Stock News	78
Original source text United Therapeutics Corporation (UTHR) Q2 2026 Earnings Call August 5, 2026 9:00 AM EDT Company Participants Harrison Silvers - Manager of Investor Relations Martine Rothblatt - Founder, Chairman & CEO Michael Benkowitz - President & COO Patrick Poisson Leigh Peterson - Executive Vice President of Product Development & Xenotransplantation Conference Call Participants Joseph Thome - TD Cowen, Research Division Jiale Song - Jefferies LLC, Research Division Jessica Fye - JPMorgan Chase & Co, Research Division Ryan Mcelroy - Leerink Partners LLC, Research Division Benjamin Burnett - Wells Fargo Securities, LLC, Research Division Ashwani Verma - UBS Investment Bank, Research Division Olivia Brayer - Cantor Fitzgerald & Co., Research Division Lisa Walter - RBC Capital Markets, Research Division Presentation Operator Good morning, and welcome to the United Therapeutics Corporation Second Quarter 2026 Corporate Update. My name is JL, and I'll be your conference operator today. [Operator Instructions] Please note that this call is being recorded. I'll now turn the webcast over to Harry Silvers, Investor Relations at United Therapeutics. Harrison Silvers Manager of Investor Relations Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation's Second Quarter 2026 Corporate Update Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website.
	Saved 2026-08-05 14:47 1mo ago Published 2026-08-05 08:46 1mo ago	United Therapeutics překonala EPS, tržby zaostaly United Therapeutics oznámila zisk na akcii 7,27 USD, nad odhadem 6,82 USD. Tržby 783,3 milionu USD ale za čtvrtletí zaostaly za očekáváním. UTHR United Therapeutics	FMP Stock News	78
Original source text United Therapeutics (UTHR - Free Report) came out with quarterly earnings of $7.27 per share, beating the Zacks Consensus Estimate of $6.82 per share. This compares to earnings of $6.41 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +6.60%. A quarter ago, it was expected that this drugmaker would post earnings of $6.73 per share when it actually produced earnings of $5.82, delivering a surprise of -13.52%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. United Therapeutics, which belongs to the Zacks Medical - Drugs industry, posted revenues of $783.3 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 2.51%. This compares to year-ago revenues of $798.6 million. The company has not been able to beat consensus revenue estimates over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. United Therapeutics shares have added about 6.5% since the beginning of the year versus the S&P 500's gain of 13%. What's Next for United Therapeutics?While United Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for United Therapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $7.03 on $819.4 million in revenues for the coming quarter and $26.65 on $3.23 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. MediWound (MDWD - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This developer of treatments for burns and hard-to-heal wounds is expected to post quarterly loss of $0.76 per share in its upcoming report, which represents a year-over-year change of +38.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. MediWound's revenues are expected to be $2.59 million, down 54.7% from the year-ago quarter.
	Saved 2026-07-24 18:10 1mo ago Published 2026-07-24 12:00 1mo ago	Liquidia hlásí třetí ziskové čtvrtletí díky Yutrepia Liquidia hlásí, že Yutrepia od spuštění v červnu 2025 táhne růst: ve 1. čtvrtletí 2026 přinesla asi 130 milionů USD tržeb a firma vykázala třetí ziskové čtvrtletí v řadě. 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.
	Saved 2026-07-09 20:25 2mo ago Published 2026-07-09 15:30 2mo ago	United Therapeutics oznamuje pozitivní výsledky Tyvaso ve fázi III United Therapeutics oznámila pozitivní výsledky fáze III pro Tyvaso u IPF, což podporuje plánované podání doplňkové žádosti u FDA. Firma zároveň cílí na roční tržby ve výši 4 miliard USD do konce roku 2027. 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%.
	Saved 2026-07-02 11:07 2mo ago Published 2026-07-02 06:30 2mo ago	United Therapeutics koupila Thymmune za 140 milionů USD United Therapeutics koupila Thymmune Therapeutics za 140 milionů USD v hotovosti, s možným earn-outem až 160 milionů USD. Thymmune vyvíjí regenerativní buněčné terapie brzlíku pro transplantace, imunodeficience a autoimunitní choroby. 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.