Ex-Dividend Date
AB Amber Grid, legal entity code: 303090867. Address: Laisvės ave. 10, LT-04215 Vilnius, Lithuania.
AB Amber Grid, hereby informs that May 14th 2025, is an ex-dividend date of AB Amber Grid. Shares acquired on this day and thereafter by transactions concluded on Nasdaq Baltic will not give the right to receive dividend allocated by the decision of the General Meeting of Shareholders held on 30th April 2025.
More information:Laura Šebekienė, Head of Communications of AB Amber Grid,Ph. +370 699 61246, e-mail: l.sebekiene@ambergrid.ltSign in to access your portfolio
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Yahoo
3 days ago
- Yahoo
Insmed Announces Positive Topline Results from Phase 2b Study of Treprostinil Palmitil Inhalation Powder (TPIP) as Once-Daily Therapy in Patients with Pulmonary Arterial Hypertension
–The Study Met Primary and All Secondary Efficacy Endpoints– Statistically Significant 35% Placebo-Adjusted Reduction from Baseline in Pulmonary Vascular Resistance for the Primary Endpoint (p<0.001) 35.5 Meter Placebo-Adjusted Improvement in Six-Minute Walk Distance for the Secondary Efficacy Endpoint (p=0.003) 60% Placebo-Adjusted Reduction from Baseline in NT-proBNP Concentrations for the Secondary Efficacy Endpoint (p<0.001) Results Were Assessed Approximately 24 Hours After Administration, Demonstrating Sustained Benefit Throughout the 24-Hour Dosing Period –TPIP Was Well Tolerated in the Study, with 75% of Patients Titrating to the Highest Dose– –Insmed to Immediately Engage with FDA to Inform Phase 3 Trial Design with Studies Expected to Begin Before End of 2025 for PH-ILD and in Early 2026 for PAH– –Insmed to Host Investor Call at 8:00 AM ET on Tuesday, June 10, 2025– BRIDGEWATER, N.J., June 10, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The study met its primary endpoint and all secondary efficacy endpoints. For the primary endpoint, the placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) was 35% with Least Squares (LS) mean ratio of 0.65 (95% CI: 0.54, 0.79; p<0.001). For the secondary efficacy endpoints, the placebo-adjusted improvement in six-minute walk distance (6MWD) was 35.5 meters (95% CI: 11.2, 60.7; p=0.003) and the placebo-adjusted reduction from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, a biomarker for cardiac stress, was 60% with LS mean ratio of 0.40 (95% CI: 0.27, 0.59; p<0.001). These results demonstrate the durability of TPIP's therapeutic effect as a once-daily therapy based on efficacy being evaluated approximately 24 hours after therapy was administered. Based on these results, Insmed will immediately engage with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design for PAH. Insmed plans to initiate a Phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a Phase 3 trial in patients with PAH in early 2026. "The statistically significant and clinically meaningful results shown with TPIP in pulmonary arterial hypertension mark a potential breakthrough for patients and the future of prostanoid therapy," said Gene Sullivan, M.D., Chief Product Strategy Officer of Insmed. "TPIP was designed with the goal of fully harnessing the potential of treprostinil and providing meaningful benefit to patients. These unprecedented Phase 2b results unequivocally demonstrate TPIP's potential to be a highly effective and well-tolerated once-daily prostanoid therapy for the treatment of PAH across disease severities and background treatment regimens. We look forward to expanding upon these results in the upcoming Phase 3 program." The study was conducted at 44 sites globally, and a total of 102 patients were randomized 2:1 to receive either TPIP (n=69) or placebo (n=33) for 16 weeks. Demographics and baseline characteristics were similar in both study arms. Patients started at a dose of 80 µg once daily (TPIP or matching placebo) and were titrated up to their maximum tolerated dose, or to the maximum allowable dose of 640 µg, once daily over a three-week period, with the possibility of a final dose increase occurring at Week 5. Of the patients treated with TPIP, 84% titrated to at least 480 µg once daily (n=58) and 75% titrated to the maximum allowed dose of 640 µg once daily (n=52). Overall, 90% of patients receiving TPIP (n=62) and all patients receiving placebo completed the study. Once-daily TPIP therapy was well tolerated in the study. Treatment-emergent adverse events (TEAEs) occurred in 88.4% of patients who received TPIP versus 75.8% of patients who received placebo; serious TEAEs were observed in 7.2% of patients who received TPIP versus 3.0% of patients who received placebo; and severe TEAEs were observed in 5.8% of patients who received TPIP versus 3.0% of patients who received placebo. TEAEs leading to treatment discontinuation were experienced by 5.8% of patients taking TPIP; there were none in the placebo arm. There were no deaths in the study. The most common TEAEs occurring in at least 5.0% of patients in any study arm, and more frequently with TPIP than with placebo, were cough (40.6%, 21.2%), headache (31.9%, 15.2%), fatigue (10.1%, 3.0%), chest discomfort (8.7%, 0.0%), flushing (8.7%, 3.0%), upper respiratory tract infection (7.2%, 3.0%), and non-cardiac chest pain (5.8%, 3.0%) for TPIP and placebo, respectively. "Today's outstanding results for TPIP represent more than a decade of hard work and the application of innovative chemistry intended to deliver a safe and effective, once-daily inhaled prostanoid therapy for patients with PAH, a devastating, progressive disease," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "Having met the primary endpoint with high statistical significance, as well as seeing positive results for all secondary efficacy endpoints, we are excited about TPIP's potential to become the prostanoid of choice. Thank you to the many patients and clinicians who participated in this study and contributed to today's historic outcome." All patients who completed the Phase 2b study were eligible to enroll in the long-term open-label extension, which will evaluate TPIP up to a maximum allowable dose of 1,280 µg once daily. Of the patients who completed the Phase 2b study (n=95), 95% enrolled in the open-label extension. Insmed plans to present detailed results from the Phase 2b study of TPIP in PAH and the open-label extension at future medical meetings. Topline results from the Phase 2a study of TPIP in patients with PH-ILD were previously reported in May 2024. Results of the Phase 2b study of TPIP in PAH, including exploratory analyses, will be discussed during the Company's investor conference call on Tuesday, June 10, 2025, at 8:00 AM ET and as part of an investor presentation available at Conference Call Information Insmed will host a conference call today at 8:00 AM ET to discuss the TPIP Phase 2b study results in PAH. The call can be accessed by dialing (888) 210-2654 (U.S. and Canada) or (646) 960-0278 (international) and entering the conference ID number 7862189. The call will also be webcast live on the Company's website at A replay of the conference call will be accessible approximately two hours after its completion through Tuesday, June 17, 2025, by dialing (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) and referencing conference ID number 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at About TPIP Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as a once-daily therapy for the treatment of patients with PAH, PH-ILD, and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. About the Phase 2b Study The Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) was a randomized, double-blind, multicenter, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of TPIP, administered once daily, in patients diagnosed with PAH (World Health Organization Group 1). The study was conducted at 44 sites and enrolled 102 adult participants. Patients started at a dose of 80 µg once daily (TPIP or matching placebo) and were titrated up to their maximum tolerated dose, or to the maximum allowable dose of 640 µg, once daily over a three-week period, with the possibility of a final dose increase occurring at Week 5. Patients self-administered TPIP or placebo using a capsule-based inhalation device. The primary endpoint was change from baseline in pulmonary vascular resistance (PVR) versus placebo at Week 16. Secondary endpoints were six-minute walk distance (6MWD), N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, pharmacokinetics, and safety/tolerability. Patients who completed the study could enroll in a long-term open-label extension, with the option to titrate up to a maximum tolerated dose of 1,280 µg once daily. About Pulmonary Arterial Hypertension Pulmonary arterial hypertension (PAH) is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. It is estimated that approximately 35,000 patients in the U.S., 40,000 patients in the EU5 (France, Germany, Italy, Spain, and the UK), and 15,000 patients in Japan have been diagnosed with the disease. Untreated, PAH can be debilitating and often fatal. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending four consecutive years as the No. 1 Science Top Employer. Visit to learn more. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that the full data set from the TPIP PAH study or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; failure to successfully conduct future clinical trials for TPIP, such as the Company's planned Phase 3 program for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; failure to obtain regulatory approval for TPIP; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved; restrictions or other obligations imposed on us by agreements related to TPIP and failure to comply with our obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors:Bryan DunnVice President, Investor Relations(646) Media:Claire MulhearnVice President, Corporate Communications(862) 842-6819media@ View original content to download multimedia: SOURCE Insmed Incorporated
Yahoo
06-06-2025
- Yahoo
Morgan Stanley Issues an Equal Weight Rating For Parker-Hannifin Corporation (PH)
On June 5, Morgan Stanley launched coverage of Parker-Hannifin Corporation (NYSE:PH) with an Equal Weight rating, assigning a price target of $700. This rating is in line with Parker-Hannifin's shift towards a secular business model, scaling its Aero division, and strengthening its position in long-cycle industrial markets by conducting mergers and acquisitions. A technician using advanced radiographic testing equipment to inspect an aircraft. Morgan Stanley analysts observed that this business transformation has led to a higher trading multiple for PH compared to historical metrics, which is demonstrated by its PE ratio of 25.3x and a strong ROE of 27%. Parker-Hannifin Corporation (NYSE:PH)'s string of successful business acquisitions further boosts its present valuation. Nevertheless, the analysts reflected on possible challenges, such as securing mid-single digit growth numbers organically in its industrial segment, which could cancel out the ongoing margin gains forecasted for PH. Parker-Hannifin Corporation (NYSE:PH) is an Ohio-based global manufacturer specializing in motion and control technologies, with the business catering to the industrial, mobile, and aerospace sectors. Top aircraft and engine manufacturers worldwide use PH's flight control, hydraulic, fuel-inerting, fluid handling, thermal management, pneumatic, and lubrication systems. While we acknowledge the potential of PH as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. Se produjo un error al recuperar la información Inicia sesión para acceder a tu portafolio Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información
Business Wire
04-06-2025
- Business Wire
Halo Biosciences Announces Thorax Publication of Phase 2a SATURN Study Results in PH-ILD
PALO ALTO, Calif.--(BUSINESS WIRE)--Halo Biosciences ('Halo'), a clinical-stage biotechnology company developing extracellular matrix-targeted therapies, today announced publication of results from the Phase 2a SATURN study in Thorax. The study, conducted at Stanford University, evaluated 4-methylumbelliferone (4-MU) in patients with pulmonary hypertension, a highly progressive disease with significant unmet needs. The SATURN study, a Phase 2a randomized, double-blind, placebo-controlled trial, enrolled 16 patients with pulmonary hypertension. 4-MU was safe and well-tolerated throughout the 24-week treatment period. The primary hemodynamic measurement of change in pulmonary vascular resistance was not statistically significant. Among patients with PH-ILD, prespecified exploratory efficacy signals showed a mean improvement of 66 meters in six-minute walk distance and enhanced quality-of-life scores. These findings support further clinical evaluation of 4-MU as a potential disease-modifying therapy for inflammatory and fibrotic lung diseases. 'These clinical data reinforce the scientific rationale for targeting hyaluronan in fibrotic and inflammatory lung disease and highlight 4-MU's potential as a first-in-class, disease-modifying ECM-modulator for patients with serious conditions like PH-ILD,' said Paul Bollyky, M.D., professor of medicine at Stanford University and scientific co-founder of Halo Biosciences. 'This represents a meaningful step forward for individuals living with PH-ILD, a condition with limited treatment options and a high burden of disease.' HB-1614, Halo's lead investigational therapy, is a proprietary, oral formulation of 4-MU optimized for improved bioavailability and long-term use in patients with chronic lung conditions such as PH-ILD. By inhibiting hyaluronan synthesis, HB-1614 targets a key driver of extracellular matrix (ECM) remodeling involved in inflammation and fibrosis—processes central to disease progression in several debilitating diseases, including PH-ILD. 'We are proud to see the SATURN study featured in Thorax, validating our translational approach and marking a key milestone in our development of HB-1614,' said Anissa Kalinowski, chief executive officer of Halo Biosciences. 'We are thankful to Stanford University and sponsor investigators Roham Zamanian, M.D., and Vinicio de Jesus Perez, M.D., for their leadership of the SATURN trial, unlocking the potential of this new mechanism of action.' Halo Biosciences is progressing clinical development of HB-1614 and exploring partnership opportunities to accelerate its work in PH-ILD and other fibrotic conditions. The company holds exclusive intellectual property for its formulation and is positioned to optimize drug delivery, bioavailability and regulatory strategy. The full manuscript is now available online. To access the paper, visit: ABOUT HB-1614 HB-1614 is Halo Biosciences' lead investigational therapy, a proprietary formulation of 4-methylumbelliferone (4-MU) designed to inhibit hyaluronan synthesis, a key driver of inflammation and fibrosis in the ECM. By targeting this dysregulated pathway, HB-1614 offers a novel, disease-modifying approach for conditions like pulmonary hypertension associated with interstitial lung disease (PH-ILD). ABOUT PULMONARY HYPERTENSION Pulmonary hypertension (PH) is a progressive condition caused by elevated blood pressure in the arteries of the lungs, leading to reduced oxygen exchange, right heart strain, and eventual heart failure. i Symptoms include breathlessness, fatigue, and dizziness ii. PH diagnosis is often delayed and accompanied by comorbidities, with most patients diagnosed between the ages of 60 and 70 iii. When PH is associated with interstitial lung disease (PH-ILD), the course of disease is often more accelerated, with these patients facing a median survival of just 2 to 5 years. iv Currently, there is only one FDA-approved therapy for PH-ILD, iv leaving a significant unmet need for therapies that target the underlying mechanisms of disease progression. New approaches are urgently needed to improve outcomes and quality of life for this vulnerable patient population. ABOUT HALO BIOSCIENCES Halo Biosciences is a clinical-stage biopharmaceutical company targeting the extracellular matrix (ECM) to transform the treatment of diseases characterized by inflammation and fibrosis. It is headquartered in Palo Alto, CA. For more information, visit i Pulmonary Fibrosis Foundation. Pulmonary Hypertension Related to Interstitial Lung Disease (for Patients). Retrieved from ii Pulmonary Hypertension Association. Diagnosing Pulmonary Hypertensio n. Accessed on June 3, 2025 from iii Mount Sinai Health System. (n.d.). Idiopathic pulmonary fibrosis. Mount Sinai Health Library. Retrieved June 3, 2025, from iv Nathan, S. D., Stinchon, M. R., Atcheson, S., Simone, L., & Nelson, M. (2025). Shining a spotlight on pulmonary hypertension associated with interstitial lung disease care: The latest advances in diagnosis and treatment. Journal of Managed Care & Specialty Pharmacy, 31(1-a Suppl), S2–S29.
