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UTHR のニュース
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United Therapeutics Authorizes Up to $2 Billion Share Repurchase Program
United Therapeutics announced that the company's Board of Directors has authorized a new share repurchase program for up to $2 billion of the company's common stock, available through October 21, 2027. "We have the balance sheet and free cash flow to fund our long-term ambitions and the confidence to act decisively when our own shares represent a compelling investment," said James Edgemond, Chief Financial Officer and Treasurer of United Therapeutics. "This authorization is a clear reflection of our deep conviction in the future of our company, our disciplined approach to capital allocation, and our commitment to delivering durable long-term value for shareholders."
United Therapeutics Opens Third Designated Pathogen-Free Facility in Texas
United Therapeutics announced the opening of its third Designated Pathogen-Free facility, The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility, in Houston, Texas. United Therapeutics opened its first DPF facility in Christiansburg, Va. in 2024 to produce xenografts for ongoing clinical trials. The two new facilities in Stewartville and Houston are designed to enable United Therapeutics to scale commercial production of its xeno-organs following approval of these products.
United Therapeutics Receives FDA Clearance for SUMMIT Clinical Trial
United Therapeutics announced that the U.S. Food and Drug Administration has granted clearance under the company's investigational new drug application to proceed with the SUMMIT clinical trial of treprostinil SMI in PH-COPD. The phase 2, 16-week, double blind SUMMIT study will evaluate the safety and tolerability of treprostinil SMI in approximately 40 patients with PH-COPD. The study's secondary endpoints will evaluate the efficacy of treprostinil SMI on exercise capacity and N-terminal pro-B-type natriuretic peptide, a critical biomarker for heart failure. Eligible patients in the SUMMIT study will be able to enroll in an open-label extension study to evaluate the long-term safety, tolerability, and efficacy of treprostinil SMI. Assuming a successful outcome in the SUMMIT study, United Therapeutics anticipates commencing a subsequent phase 3 registration study for treprostinil SMI in PH-COPD in 2028. Treprostinil SMI includes a portable, handheld soft mist inhaler designed to deliver a preserved formulation of inhaled treprostinil solution in a single breath. The product will be available for the clinical study in multiple dose strengths to support individualized titration and long-term maintenance dosing, administered four times daily. Each single-load cartridge is designed to support up to two weeks of use, and the product can be stored at room temperature, offering patients a convenient, easy-to-carry delivery option. United Therapeutics also plans to develop treprostinil SMI for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis. Treprostinil SMI is an investigational-stage product, and is not yet approved in any jurisdiction for any indication.
Major U.S. Averages Decline as CPI Rises
The major averages were lower near noon, pressured by higher Treasury yields as well as the September CPI report, which came in hotter than expected. Headline CPI rose 0.6% month-over-month and 3.7% year-over-year, compared with expectations for 0.6% and 3.6%, respectively. Core CPI, which excludes food and energy, increased 0.3% monthly and 2.6% annually, topping forecasts of 0.2% and 2.5%.Meanwhile, oil prices are surging over 1% once again as attacks on vessels in the Strait of Hormuz heighten concerns about disruptions to global energy supplies.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Bank of Americareported lower-than-expected Q3 results a day after the Treasury Department fined the bank $1.2B over money laundering violationsMorgan Stanleyreported upbeat Q3 results, with the company saying banking pipelines "remain high"Netflixis laying off 6% of its staff, WSJ reportsBerkshire Hathawayis investing an additional $330M in Bending SpoonsASMLreported better-than-expected Q3 results and narrowed its FY26 revenue outlook2. WALL STREET CALLS:Brinkerupgraded to Buy at JefferiesJefferies also upgraded Texas Roadhouseto BuyLockheed Martinupgraded to Buy at Vertical Research following selloffAlbertsonsdowngraded to Underperform at BofABarclays downgraded HP Enterprise, Delland NetAppto Equal Weight3. AROUND THE WEB:Palantirand London Mayor Sadiq Khan's policing office have agreed to drop legal proceedings over a blocked GBP 50M Met Police AI and data analytics contract, Politico reportsThree people were seriously injured in an explosion at Intel'smanufacturing facility in Israel, Calcalist reportsThe FBI worked with CrowdStriketo dismantle more than 40 laptop farms and seize nearly 200 computer devices across Texas used to help North Koreans get remote U.S. tech jobs under stolen identities, NY Times saysGeneral Atlantic is planning to go public as early as spring 2027 and its IPO could be valued at up to $10B, FT reportsNvidia'scontrol of China's market for AI chips fell to 34% in 1H of 2026, mainly due to strict U.S. export controls and domestic rivals gaining ground, Reuters says4. MOVERS:Liquidiagains after announcing a global settlement agreement with United TherapeuticsVerastemincreases after appointing Michel Bailey as CEOGlobalFoundrieshigher after receiving up to $21B in funding for two new semiconductor manufacturing facilitiesStrivelower after announcing a 5M share offering of SATS preferred stockInniofalls in New York after Morgan Stanley lowered its price target on the stock to $405. EARNINGS/GUIDANCE:Camtekprovided guidance for Q3, Q4, and FY27MaxCytereported preliminary Q3 results and raised its outlook for FY26AZZreported Q2 results and increased its guidance for FY27Fastenalreported Q3 results, with EPS and revenue beating consensusSono-Tekreported Q2 results, with CEO Steve Harshbarger commenting FY27 is "progressing well"INDEXES:Near midday, the Dow was down 46.41, or 0.09%, to 51,623.69, the Nasdaq was down 369.46, or 1.36%, to 26,834.93, and the S&P 500 was down 71.44, or 0.92%, to 7,734.01.
Liquidia and United Therapeutics Reach $175M Settlement Agreement
Liquidia (LQDA) and United Therapeutics (UTHR) reached a global settlement agreement that resolves all pending litigation between the companies. YUTREPIA, or treprostinil, inhalation powder will remain available to patients with PAH without disruption. Under the agreement, Liquidia will make a net payment to UTHR of $175M within 30 business days. The net payment includes funds paid by UTHR to Liquidia to resolve the antitrust litigation tied to Treprostinil Injection. Liquidia will also pay $145.4M in two equal installments of $72.7M due on or before January 31, 2027, and April 30, 2027, respectively. In connection with the settlement, Liquidia entered into agreements with the parties with interests in the antitrust litigation related to Treprostinil Injection. Under those agreements, Liquidia will pay an aggregate of $60.3M this month in full satisfaction of those parties' interests in the antitrust litigation. Concurrently, Liquidia terminated the promotional agreement tied to Treprostinil Injection and will no longer commercially support the product in the market. Michael Kaseta, COO and CFO, said: "We are confident this settlement is in the best interests of our patients and shareholders and in our ability to meet the settlement obligations while continuing to invest in the business. We expect to fund the outlined payments from the ongoing sales of YUTREPIA and cash on hand. Preliminary and unaudited results from the third quarter 2026 included YUTREPIA net product sales of $222.7M, contributing to total cash and cash equivalents of $396.1M as of September 30. We expect to rebuild our cash position and fund our planned clinical studies without requiring additional financing." Liquidia will provide a broader update on YUTREPIA's performance, its financial position and its pipeline priorities on its third-quarter 2026 earnings call in November.
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