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Irish Examiner
24-05-2025
- Entertainment
- Irish Examiner
'Female friendship is not a perfect love story any more than a romantic relationship is'
When Vicki Notaro was a child, she used to watch Beaches starring Bette Midler and Barbara Hershey, every Saturday with her cousin Trevor at her Granny's house. 'We had a VHS copy of it, and we would cry at the end every single time,' she says, laughing. It was this ritual that sparked an idea in Notaro. She explains: 'You know how they talk about 'the one' in relationships? To me, there's always been 'the one' in friendships. I wanted to write about the complications of female friendships and how difficult they can be. They're not this perfect love story any more than a romantic relationship is, so I was heavily inspired by that movie and its two lead characters, 'Hillary' and 'CC' There are references to it throughout my latest book Long Story.' The appeal of this genre, she says, lies in its ability to transport you to another world… an escape. 'Something I've learned, even in doing my podcast You Had Me at Hello, is that sometimes you just need a good whinge. And that's what romantic comedies are for. As much as they're there for laughs, they're also there for sadness.' This sentiment rings true in Notaro's own writing and, of course, the aforementioned Long Story. I've known Notaro for a long time in my professional career. I'm familiar with her writing, her affection for women and innate instinct for what makes them tick, what compels them to pick up a magazine (she was formerly editor in chief of STELLAR). This connection to women's stories now extends to books. So, I ask her: What was the first book that depicted female friendship in such a real and impactful way that it influenced her writing? 'The book that's influenced me the most in my whole career is Rachel's Holiday by Marian Keyes. In that book, her best friend is the one who tells her she's a drug addict. They're kind of acting out together, but it's Rachel who takes it too far, and her friend is the one who calls her out on this. 'I think that was the first time I realised that friendship wasn't just easy. It can be difficult. It has its ups and downs. Even in the sequel, 25 years after the first one, Again, Rachel, they're still friends. It depicted how complex a friendship could be. It wasn't just, 'We love each other and that's that.' Vicki Notaro: 'I think it's impossible to write a novel without some of your own life leaking into it.' 'Relationships change over time. So, someone who was your 'one' in friendship years ago, might not be your 'one' now. I think it's important not to beat ourselves up if things don't work out, but I love exploring how complex the ties in friendship can be.' Speaking of complexity, does Notaro find it difficult to avoid letting her own life and the people in it bleed onto the page? 'I think it's impossible to write a novel without some of your own life leaking into it. They say, 'Write what you know,' so with everything I write, it's impossible to distance myself from it. 'Everyone close to me always reads it before it goes to print. In fact, one of my friends named my first book Reality Check. It's a community effort. It's not just me. I'm pulling on strings from everyone.' Her latest book focuses on the dynamics between two women who, despite following very different paths, have remained best friends. Notaro elaborates: 'One of them is Tara, an Oscar-winning actress, and the other is Alex, a podcaster and lifestyle journalist. 'Despite their vastly different lifestyles — living on different continents and in different personal stages — they've managed to maintain their friendship. But then, an incident occurs that threatens everything…' She trails off with a mysterious smile. 'For me, it was interesting to throw a spanner in their works. They feel like real people, so I thought, 'What would be the one thing that could split them up?' That comes in the form of a man called Sean Sweeney who will test the very core of their 20-year friendship.' Long Story by Vicki Notaro I want to chat further about the evolution of female friendships in popular culture. Notaro says, 'I came of age at a time when friendship was really hot: Friends, Sex and the City. I thought I'd grow up and celebrate Thanksgiving with my friends in my purple apartment. The reality of that was quite different. 'People tend to celebrate those moments with their families. But now, there's this idea of 'chosen family,' which I think is powerful. I'm lucky to often combine the two. 'Later shows like Girls depicted friendship in such a real way. You'd see them, having a big screaming fight, and then 10 minutes later, they're outside doing a dance.' When discussing female friendship, it's impossible to overlook the latest season of The White Lotus. In season three, we see its nuanced portrayal of the complexities within long-standing ties. While many critics throughout the season labelled the trio's dynamic as 'toxic,' the finale reveals an unexpected depth. Carrie Coon's character delivers a poignant speech that highlights the stark difference between superficial friendships and the deeper connections that demand vulnerability, sacrifice, and honesty. 'Mike White is renowned for crafting polarising characters. Even in my book, Tara and Alex are each other's person, and yet, the portrayal acknowledges that no one is perfect,' Notaro reflects. 'Expecting perfection from someone simply because you love them is a tall order. What struck me as well, was the age of these characters. Too often, we see female friendships portrayed through the lens of women in their 20s or 30s, or in the later years, as with shows like Grace and Frankie. Vicki Notaro: 'I thought I'd grow up and celebrate Thanksgiving with my friends in my purple apartment. The reality of that was quite different.' 'It's rare to see women in their 40s navigating such complex dynamics. And I love that these women are, in a sense, 'spoiled brats', on a glamorous vacation. It's refreshing to see a portrayal that feels real and raw, women who are beautifully imperfect.' Notaro herself has experienced unwavering support from the women in her life since she made the decision to write fiction, and prior to that in her career in journalism. 'I love the concept of ditching the scarcity mindset. There's room enough for all of us at the table, as long as you have great ideas and are willing to work hard. Nobody likes a chancer,' she laughs. 'But I've only ever experienced people being unbelievably kind to me, from my first magazine job, to the launch of my first book. My heroes like Marian Keyes, Patricia Scanlon, and Cathy Kelly lifted me up and supported me from the get-go. I want to do that for people who want to write fiction now, too. 'The support has been astonishing, from these incredible Irish writers that I've read and admired my whole life. 'To be able to make this pivot to writing fiction really is a dream come true.' Long Story by Vicki Notaro, published by Sandycove, is out on May 29 Read More From daydreaming about bank heists to TV adaptations: Andrea Mara on her writing career
Yahoo
16-05-2025
- Business
- Yahoo
Merck to Present New Clinical and Outcomes Research Data at The American Thoracic Society's (ATS) 2025 International Conference Demonstrating Commitment to Advancing Research in Pulmonary Arterial Hypertension
Preliminary results from a pooled analysis of clinical trial data evaluating the long-term safety and favorable benefit-risk profile of WINREVAIR™ to be featured as a late-breaking presentation RAHWAY, N.J., May 16, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society's (ATS) 2025 International Conference in San Francisco from May 16-21. Data from nine presentations demonstrate Merck's commitment to advancing research for patients with this disease. Merck will present pooled data from participants who have completed the PULSAR, SPECTRA, or STELLAR studies and have continued in the ongoing open-label extension study, SOTERIA, evaluating the long-term safety, tolerability and efficacy of WINREVAIR™ (sotatercept-csrk) when added to background therapy for the treatment of PAH. These results represent the largest analysis of WINREVAIR to date. "The results from this pooled analysis add to the growing body of evidence for WINREVAIR," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We remain confident in the long-term potential for WINREVAIR for patients with PAH and look forward to sharing findings as we continue to evaluate WINREVAIR." Merck will also present an overall survival analysis for WINREVAIR leveraging data from the pivotal Phase 3 study, STELLAR, and interim data from participants who have continued in the ongoing open-label SOTERIA study, as well as additional outcomes research on the burden and impact of PAH in various patient populations. Details on Merck abstracts at ATS: PAH Long-term safety and exposure-adjusted incidence rates of adverse events from pooled sotatercept studies (PULSAR, SPECTRA, STELLAR, and SOTERIA). I. Preston. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Overall survival of patients on sotatercept: an analysis of STELLAR and SOTERIA trials. T. Thakur. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Long-term safety of MK-5475 in pulmonary arterial hypertension (PAH): Results from the phase 2 INSIGNIA-PAH extension period. P. Hassoun. Poster Board #505; D28 Fisherman's Wharf: Clinical and epidemiological insights into pulmonary hypertension: trends, treatments, and outcomes on Wednesday, May 21, 11:15 a.m. – 1:15 p.m. ET/8:15 – 10:15 a.m. PT Quantifying the impact of pulmonary arterial hypertension (PAH) on health-related quality of life (HRQOL), work productivity, and economic stability for patients and their caregivers. H. Black. Poster Board #1018; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 –11:15 a.m. PT Comparing the burden of pulmonary arterial hypertension (PAH) among women across regions: a patient survey. T. Thakur. Poster Board #1021; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 – 2:15 p.m. ET/9:15 – 11:15 a.m. PT Perceptions, attitudes and behaviors among women of childbearing and childrearing age with pulmonary arterial hypertension. T. Thakur. Poster Board #1020; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 – 11:15 a.m. PT The impact of cardiopulmonary comorbidities on the economic burden and mortality of pulmonary arterial hypertension in the United States. H. Black. Poster Board #P253; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Caregiver network and caregiving needs in women with pulmonary arterial hypertension (PAH). T. Thakur. Poster Board #P254; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Acute inpatient utilization among Medicaid patients treated for pulmonary arterial hypertension. A. Watanabe. Poster Board #P251; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at Patient Information for WINREVAIR at and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at View source version on Contacts Media Contacts:Julie Cunningham(617) 519-6264Courtney Ronaldo(908) 442-5695Investor Contacts:Peter Dannenbaum(732) 594-1579Steven Graziano(732) 594-1583 Error while retrieving data Sign in to access your portfolio Error while retrieving data
Yahoo
16-05-2025
- Business
- Yahoo
Merck to Present New Clinical and Outcomes Research Data at The American Thoracic Society's (ATS) 2025 International Conference Demonstrating Commitment to Advancing Research in Pulmonary Arterial Hypertension
Preliminary results from a pooled analysis of clinical trial data evaluating the long-term safety and favorable benefit-risk profile of WINREVAIR™ to be featured as a late-breaking presentation RAHWAY, N.J., May 16, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society's (ATS) 2025 International Conference in San Francisco from May 16-21. Data from nine presentations demonstrate Merck's commitment to advancing research for patients with this disease. Merck will present pooled data from participants who have completed the PULSAR, SPECTRA, or STELLAR studies and have continued in the ongoing open-label extension study, SOTERIA, evaluating the long-term safety, tolerability and efficacy of WINREVAIR™ (sotatercept-csrk) when added to background therapy for the treatment of PAH. These results represent the largest analysis of WINREVAIR to date. "The results from this pooled analysis add to the growing body of evidence for WINREVAIR," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We remain confident in the long-term potential for WINREVAIR for patients with PAH and look forward to sharing findings as we continue to evaluate WINREVAIR." Merck will also present an overall survival analysis for WINREVAIR leveraging data from the pivotal Phase 3 study, STELLAR, and interim data from participants who have continued in the ongoing open-label SOTERIA study, as well as additional outcomes research on the burden and impact of PAH in various patient populations. Details on Merck abstracts at ATS: PAH Long-term safety and exposure-adjusted incidence rates of adverse events from pooled sotatercept studies (PULSAR, SPECTRA, STELLAR, and SOTERIA). I. Preston. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Overall survival of patients on sotatercept: an analysis of STELLAR and SOTERIA trials. T. Thakur. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Long-term safety of MK-5475 in pulmonary arterial hypertension (PAH): Results from the phase 2 INSIGNIA-PAH extension period. P. Hassoun. Poster Board #505; D28 Fisherman's Wharf: Clinical and epidemiological insights into pulmonary hypertension: trends, treatments, and outcomes on Wednesday, May 21, 11:15 a.m. – 1:15 p.m. ET/8:15 – 10:15 a.m. PT Quantifying the impact of pulmonary arterial hypertension (PAH) on health-related quality of life (HRQOL), work productivity, and economic stability for patients and their caregivers. H. Black. Poster Board #1018; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 –11:15 a.m. PT Comparing the burden of pulmonary arterial hypertension (PAH) among women across regions: a patient survey. T. Thakur. Poster Board #1021; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 – 2:15 p.m. ET/9:15 – 11:15 a.m. PT Perceptions, attitudes and behaviors among women of childbearing and childrearing age with pulmonary arterial hypertension. T. Thakur. Poster Board #1020; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 – 11:15 a.m. PT The impact of cardiopulmonary comorbidities on the economic burden and mortality of pulmonary arterial hypertension in the United States. H. Black. Poster Board #P253; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Caregiver network and caregiving needs in women with pulmonary arterial hypertension (PAH). T. Thakur. Poster Board #P254; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Acute inpatient utilization among Medicaid patients treated for pulmonary arterial hypertension. A. Watanabe. Poster Board #P251; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at Patient Information for WINREVAIR at and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at View source version on Contacts Media Contacts:Julie Cunningham(617) 519-6264Courtney Ronaldo(908) 442-5695Investor Contacts:Peter Dannenbaum(732) 594-1579Steven Graziano(732) 594-1583 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
16-05-2025
- Business
- Business Wire
Merck to Present New Clinical and Outcomes Research Data at The American Thoracic Society's (ATS) 2025 International Conference Demonstrating Commitment to Advancing Research in Pulmonary Arterial Hypertension
BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society's (ATS) 2025 International Conference in San Francisco from May 16-21. Data from nine presentations demonstrate Merck's commitment to advancing research for patients with this disease. Merck will present pooled data from participants who have completed the PULSAR, SPECTRA, or STELLAR studies and have continued in the ongoing open-label extension study, SOTERIA, evaluating the long-term safety, tolerability and efficacy of WINREVAIR™ (sotatercept-csrk) when added to background therapy for the treatment of PAH. These results represent the largest analysis of WINREVAIR to date. "The results from this pooled analysis add to the growing body of evidence for WINREVAIR,' said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. 'We remain confident in the long-term potential for WINREVAIR for patients with PAH and look forward to sharing findings as we continue to evaluate WINREVAIR." Merck will also present an overall survival analysis for WINREVAIR leveraging data from the pivotal Phase 3 study, STELLAR, and interim data from participants who have continued in the ongoing open-label SOTERIA study, as well as additional outcomes research on the burden and impact of PAH in various patient populations. Details on Merck abstracts at ATS: PAH Long-term safety and exposure-adjusted incidence rates of adverse events from pooled sotatercept studies (PULSAR, SPECTRA, STELLAR, and SOTERIA). I. Preston. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Overall survival of patients on sotatercept: an analysis of STELLAR and SOTERIA trials. T. Thakur. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Long-term safety of MK-5475 in pulmonary arterial hypertension (PAH): Results from the phase 2 INSIGNIA-PAH extension period. P. Hassoun. Poster Board #505; D28 Fisherman's Wharf: Clinical and epidemiological insights into pulmonary hypertension: trends, treatments, and outcomes on Wednesday, May 21, 11:15 a.m. – 1:15 p.m. ET/8:15 – 10:15 a.m. PT Quantifying the impact of pulmonary arterial hypertension (PAH) on health-related quality of life (HRQOL), work productivity, and economic stability for patients and their caregivers. H. Black. Poster Board #1018; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 –11:15 a.m. PT Comparing the burden of pulmonary arterial hypertension (PAH) among women across regions: a patient survey. T. Thakur. Poster Board #1021; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 – 2:15 p.m. ET/9:15 – 11:15 a.m. PT Perceptions, attitudes and behaviors among women of childbearing and childrearing age with pulmonary arterial hypertension. T. Thakur. Poster Board #1020; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 – 11:15 a.m. PT The impact of cardiopulmonary comorbidities on the economic burden and mortality of pulmonary arterial hypertension in the United States. H. Black. Poster Board #P253; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Caregiver network and caregiving needs in women with pulmonary arterial hypertension (PAH). T. Thakur. Poster Board #P254; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Acute inpatient utilization among Medicaid patients treated for pulmonary arterial hypertension. A. Watanabe. Poster Board #P251; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Expand About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at
