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United Therapeutics Files FDA Application for Nebulized Tyvaso to Treat IPF
United Therapeutics announced that the FDA has accepted the supplemental New Drug Application, or sNDA, for nebulized Tyvaso, or treprostinil, Inhalation Solution to treat IPF. United Therapeutics anticipates the agency's review to be complete in late April 2027. Nebulized Tyvaso has not been approved by the FDA for IPF and remains investigational for this indication. The filing was based on positive results from the phase 3 TETON-1 and TETON-2 studies. Combined analyses of TETON-1 and TETON-2 met the primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant superiority over placebo for the change in absolute forced vital capacity, or FVC, by 111.8 mL from baseline to week 52 in an IPF population broadly treated with background therapy. The combined analyses also showed that nebulized Tyvaso achieved statistical significance for most key secondary endpoints, including reduced risk of a clinical worsening event, reduced risk of acute IPF exacerbation, and changes in percent of predicted FVC, King's Brief Interstitial Lung Disease quality of life questionnaire, and diffusion capacity of lungs for carbon monoxide, or DLCO. TETON-1 data were presented as part of the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session at the 2026 annual meeting of the American Thoracic Society. TETON-2 data were published in The New England Journal of Medicine. Combined results from TETON-1 and TETON-2 were presented during an oral session at ATS and simultaneously published in The New England Journal of Medicine. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF. A post-hoc analysis of the INCREASE study in patients with pulmonary hypertension associated with interstitial lung disease suggested that nebulized Tyvaso was associated with a significant improvement in FVC, laying the foundation for the TETON clinical program to evaluate the use of nebulized Tyvaso in IPF and progressive pulmonary fibrosis.
Trump Considers New Semiconductor Tariffs Impacting Multiple Companies
Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Donald Trump with this daily recap compiled by The Fly.SEMICONDUCTOR TARIFFS:The Trump administration is considering broad new semiconductor tariffs that could extend to chip-containing products such as laptops and data-center servers, potentially raising AI infrastructure costs while linking tariff relief to U.S. manufacturing investment, Politico's Ari Hawkins and Gabby Miller. The administration is also mulling a phase-in period for the new tariffs, people familiar with the matter say. Publicly traded companies in the space include AMD, Intel, Marvell, Microchip, Micron, Nvidia, Qualcommand Texas Instruments.GRID EQUIPMENT:President Trump signed an emergency order that bars the U.S. purchase or installation of certain foreign-made, bulk-power system electrical equipment, and associated software, where it could pose cybersecurity or operational risks, Jennifer Dlouhy of Bloomberg, citing a White House official. Publicly traded companies in the solar space include Array Technologies, Canadian Solar, Emeren, Enphase Energy, FTC Solar, First Solar, JinkoSolar, Maxeon Solar, Shoals Technologies, SolarEdge, SunPowerand Sunrun.DRUG PRICING DEALS:The Trump administration is set to announce new drug pricing agreements with several midsized biotechs, trading Medicaid discounts tied to international prices for exemptions from certain Medicare pricing pilots and, in some cases, tariff relief, Bloomberg's Nyah Phengsitthy, Rachel Cohrs Zhang, and Madison Muller. Publicly traded companies in the space include Neurocrine Biosciences, Exelixis, Alnylam, BioMarin, United Therapeutics, Ionis, Bio-Techne, and Alkermes.DATA-SHARING DEALS:The Trump administration has struck data-sharing deals with OpenAI, Google, Meta, Amazon, and other tech companies to track how AI is affecting jobs and hiring, Courtenay Brown of Axios. The Labor Department has signed memorandums of understanding with "a lot of these tech companies," acting Labor Secretary Keith Sonderling told Axios.
United Therapeutics' Ralinepag NDA Accepted by FDA
United Therapeutics announced that the FDA has accepted the New Drug Application, NDA, for ralinepag to treat PAH. The FDA has set a Prescription Drug User Fee Act target action date of June 24, 2027. Ralinepag has not been approved for use in any indication by the FDA and remains investigational for PAH. "Ralinepag has the potential to make an important difference for adults living with PAH - a complex, progressive, and life-threatening disease that can severely impact daily life and lead to right heart failure," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "With the NDA now accepted for review, we are one step closer to offering PAH patients a new, once-daily oral treatment. In our clinical trial, ralinepag delayed disease progression, achieved clinical improvement, and provided durability of effect over many years. We attribute these robust results to its unique chemistry and multi-pathway effects, including vasodilation and anti-proliferative and anti-inflammatory activity."
United Therapeutics Q2 Revenue at $783.3M, Below Consensus
Reports Q2 revenue $783.3M, consensus $804.65M. "We just submitted what we believe are two of the most important NDAs in rare pulmonary disease history: ralinepag tablets in PAH and Nebulized Tyvaso in IPF," said Martine Rothblatt, Chairperson and CEO of United Therapeutics. "We believe that these submissions, accompanied by our planned filings later this year - an IND application for ralinepag DPI and an NDA for treprostinil SMI - may herald an opportunity for a quantum increase in our growth by the end of the decade. By next year, we expect potential approvals for Nebulized Tyvaso in IPF and ralinepag tablets in PAH, two potentially transformative, multi-billion-dollar catalysts that could significantly enhance our growth profile. We expect Tyvaso DPI will then follow Nebulized Tyvaso's wake into IPF and then PPF. Moreover, our organ manufacturing pipeline continues to advance rapidly with clinical trials ongoing or being planned for liver, kidney, heart, and lung products, and the launch later this year of two xeno-organ production facilities in Minnesota and Texas."
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