Latest news with #LDL-C
Yahoo
01-08-2025
- Health
- Yahoo
Novartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use
Leqvio can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in patients with hypercholesterolemia (high LDL-C)1 4 out of 5 atherosclerotic cardiovascular disease (ASCVD) patients do not reach guideline-recommended LDL-C target, reinforcing urgent need for more aggressive LDL-C lowering2-5 Twice-yearly Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment EAST HANOVER, N.J., July 31, 2025 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia1. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. "This first-line label update reinforces Leqvio's proven ability to effectively lower LDL-C, a critical risk factor for heart disease," said Victor Bultó, President, US, Novartis. "With this new indication enabling Leqvio's use as monotherapy along with diet and exercise, we now have the potential to help even more patients achieve their LDL-C lowering goals earlier in their treatment journey." With its twice-yearly, health care provider-administered dosing, Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment. This is a critical unmet need, as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL2-5. This need is heightened by the latest 2025 ACC/AHA Joint Committee Clinical Practice Guideline for the Management of Patients with Acute Coronary Syndromes, which recommends more aggressive treatment to achieve LDL-C targets6. The updated label removes the requirement for Leqvio to be used on top of or in combination with statin therapy1. Other updates include revising "primary hyperlipidemia" to the more specific term of "hypercholesterolemia" throughout the label, to more accurately focus on LDL-C reduction1. *After an initial dose and another at three months. About LeqvioLeqvio is an injectable prescription medicine indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics. Important Safety InformationDo not use if you have had an allergic reaction to Leqvio or any of its ingredients. The most common side effects of Leqvio were injection site reaction (including pain, redness, and rash), arthralgia (joint pain), bronchitis (chest cold). These are not all the possible side effects of Leqvio. Ask your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for Leqvio full Prescribing Information. About Atherosclerotic Cardiovascular Disease (ASCVD)Cardiovascular disease (CVD) affects hundreds of millions of people and claims more lives globally than cancer, chronic lung disease and diabetes combined7. Around 80% of premature cardiovascular deaths can be prevented by addressing factors that cause or worsen accounts for 85% of all CV deaths5,9-11. Its burden in the US is greater than that of any other chronic diseases5,9-11. ASCVD is caused by the development and growth of plaques in the inner lining of the arteries12. The atherosclerotic plaque is mainly composed of low-density lipoprotein cholesterol (LDL-C) that accumulates over time13. Cumulative exposure to LDL-C can increase one's risk of cardiovascular events such as a heart attack or stroke12,13. About Novartis in Cardiovascular DiseaseAt Novartis, our mission is to ensure no heart is lost too soon. We envision a world where preventable CV deaths are no longer part of our lives. We're proud of the positive impact we've made over the past 40 years and remain dedicated to tackling the most challenging problems in CVD. Through cutting-edge science and technology, we are focusing on areas of high unmet need, including scaling our xRNA platform across multiple risk factors and pioneering breakthroughs for genetically driven CVD risk factors and common heart conditions, including atrial fibrillation. We also work with patients, healthcare professionals, and organizations around the world to improve CV care beyond medicine alone. Together, we can help people with CVD enjoy longer, healthier lives and more time with their loved ones. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn US, X/Twitter US and Instagram. References Leqvio. Prescribing information. Novartis Pharmaceuticals Corp Cannon CP, de Lemos JA, Rosenson RS, et al. Use of lipid-lowering therapies over 2 years in GOULD, a registry of patients with atherosclerotic cardiovascular disease in the US. JAMA Cardiol. 2021;6(9):1060-1068. doi:10.1001/jamacardio.2021.1810 Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/ Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1016/ Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2025;85(22):2135-2237. doi:10.1016/ American Heart Association. More than half of U.S. adults don't know heart disease is leading cause of death, despite 100-year reign. Published January 24, 2024. Accessed July 25, 2025. World Heart Federation. World Heart Report 2023: confronting the world's number one killer. Published May 20, 2023. Accessed July 25, 2025. World Health Organization. Cardiovascular diseases (CVDs). Published June 11, 2021. Accessed July 25, 2025. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220. doi:10.1161/CIR.0b013e31823ac046 Kim H, Kim S, Han S, et al. Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors in Korea: a nationwide population-based study. BMC Public Health. 2019;19(1):1112. doi:10.1186/s12889-019-7439-0 Goldstein JL, Brown MS. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161(1):161-172. doi:10.1016/ Ference BA, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids on cardiovascular health: JACC Health Promotion Series. J Am Coll Cardiol. 2018;72(10):1141-1156. doi:10.1016/ ### Novartis Media Relations E-mail: Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: original content: SOURCE Novartis Pharmaceuticals Corporation 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
Yahoo
14-07-2025
- Health
- Yahoo
Health Canada Extends the Approval of Evkeeza® (evinacumab) to Children as Young as 6-months Old with Homozygous Familial Hypercholesterolemia (HoFH)
First and only medicine approved by Health Canada for patients as young as 6-months of age with HoFH, an ultrarare, inherited form of high cholesterol TORONTO, July 14, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultra-rare genetic diseases, today announced that Health Canada has extended the approval of Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat children aged 6-months and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza, an angiopoietin-like 3 (ANGPTL3) inhibitor initially received Health Canada approval in September 2023 as an adjunct to diet and other LDL-C lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with HoFH, a disease associated with dangerously high levels of LDL-C. "Early detection and prompt initiation of effective treatment are essential to prevent the devastating consequences of very high cholesterol that begins at a very young age for patients with HoFH. However, conventional treatment options are challenging for infants and children,' stated Dr. Brian McCrindle, a pediatric lipid specialist at The Hospital for Sick Children, University of Toronto. 'This extended approval will enable the very early and effective lowering of lipid levels essential for these vulnerable patients." The pharmacokinetics and efficacy of the drug in pediatric patients aged 6 months to less than 5 years with HoFH have been predicted from a model-based extrapolation analysis. Results of these analyses show that pediatric patients aged 6 months to less than 5 years are predicted to experience a similar or higher magnitude of percent change in LDL-C at week 24 compared to older pediatric patients and adults, when receiving a 15 mg/kg dose every 4 weeks. In addition, supportive data for five patients who initiated treatment between 1 and 4 years of age via compassionate use showed a clinically meaningful reduction of LDL-C consistent with that observed in patients aged 5 years or older in clinical studies. Based on the currently available data, the safety profile in pediatric patients aged 6-months to 5 years old is expected to be similar to the safety profile in older pediatric patients. No new safety concerns have been identified in the compassionate use program. "HoFH is a severe, life-threatening condition that, if left untreated, can lead to heart disease and death as early as childhood. This makes diagnosing it and reducing the resulting high LDL-C levels an urgent need,' said Monty Keast, Vice President and General Manager at Ultragenyx Canada. 'We are proud to be able to provide children as young as 6-months old living with HoFH a medicine that could reduce LDL-C levels and will work collaboratively with healthcare providers and payers across the country to ensure it is accessible for families.' Evkeeza is reimbursed and commercially available to prescribe for appropriate patients with HoFH in Canada via private drug plans and through the public drug program in Quebec, the UK, U.S., Italy, Japan, the Netherlands, Spain and Luxembourg. It is also available via early access programs in 13 additional countries including Austria and France. About Homozygous Familial Hypercholesterolemia (HoFH)HoFH is a devastating form of inherited hypercholesterolemia, affecting 1 in 300,000 people globally and 1 in 275,000 in the French Canadian population. HoFH occurs when two copies of the familial hypercholesterolemia (FH)-causing genes are inherited, one from each parent, resulting in dangerously high levels (>10 mmol/L) of LDL-C, or bad cholesterol. Patients with HoFH are at risk for premature atherosclerotic disease and cardiac events at an early age. For more information about HoFH please go to About Evkeeza (evinacumab)Evinacumab, the active substance in the medicine, attaches to a protein in the body called ANGPTL3 and blocks its effects. ANGPTL3 is involved in controlling cholesterol levels and blocking its effect reduces the level of cholesterol in the blood. The medicine is delivered via an infusion every month (4 weeks). Regeneron Pharmaceuticals, Inc. discovered and developed Evkeeza, and commercializes the product in HoFH in the U.S. under the generic name evinacumab-dgnb, with dgnb as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Ultragenyx is responsible for development and commercialization efforts in countries outside of the U.S. What is Evkeeza used for? Evkeeza is used to treat adults and children aged 6 months and older with very high cholesterol caused by a condition called homozygous familial hypercholesterolemia (HoFH). Evkeeza is used with a low-fat diet and other medicines to bring down cholesterol levels. Do not use Evkeeza if: • Allergic to evinacumab or to any of the ingredients in this medicine. To help avoid side effects and ensure proper use, a healthcare professional should be consulted before taking Evkeeza. Talk about any health conditions or problems, including: • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Symptoms may include swelling of the lips, tongue, or throat that make it difficult to swallow or breathe, and may also include wheezing, feeling dizzy, or fainting. If any of these symptoms are noticed, stop taking Evkeeza and get immediate medical help. • If pregnant, might be pregnant, or plan to become pregnant, ask a healthcare professional for advice before taking Evkeeza. Evkeeza may harm an unborn baby. Tell a healthcare professional if become pregnant while using Evkeeza. • If breastfeeding or plan to breastfeed, ask a healthcare professional for advice before being given Evkeeza. It is not known if Evkeeza passes into breast milk. Tell a healthcare professional about all the medicines taken, including any drugs, vitamins, minerals, natural supplements, or alternative medicines. What are the possible side effects from using Evkeeza? These are not all the possible side effects when taking Evkeeza. If any side effects not listed here are experienced, tell a healthcare professional. • Abdominal pain • Back pain • Constipation • Decreased energy • Dizziness • Flu symptoms • Itchiness at the site of the injection • Nausea • Pain in legs or arms • Runny nose • Fatigue (for patients aged 5-11 years old) • Sore throat or sinus infection Reporting Side Effects: Any suspected side effects associated with the use of health products can be reported to Health Canada by: • Visiting the Web page on Adverse Reaction Reporting ( for information on how to report online, by mail or by fax; or • Calling toll-free at 1-866-234-2345. NOTE: Contact a health professional if information is needed about how to manage side effects. The Canada Vigilance Program does not provide medical advice. Please see PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION for more information. About Ultragenyx Pharmaceutical is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx's strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency. For more information on Ultragenyx, please visit the company's website at: Ultragenyx Forward-Looking Statements and Use of Digital MediaExcept for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx's expectations and projections regarding its future operating results and financial performance, anticipated cost or expense reductions, the timing, progress and plans for its clinical programs and clinical studies, future regulatory interactions, and the components and timing of regulatory submissions are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, commercial success of its products and product candidates, continued collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to reliance on third party partners to conduct certain activities on the Company's behalf; the potential for any license or collaboration agreement, including Ultragenyx's collaboration agreement with Regeneron to commercialize Evkeeza outside of the United States, to be terminated; uncertainty and potential delays related to clinical drug development; uncertainties and unpredictability of obtaining regulatory approval for the Company's product candidates and the scope of such potential regulatory approval; smaller than anticipated market opportunities for the Company's products and product candidates; fluctuations in buying or distribution patterns by distributors and specialty pharmacies; competition to the Company's products and product candidates; potential undesirable or serious side effects from the Company's products or product candidates; the Company's ability to effectively manage the expansion of its commercial organization; market acceptance of the Company's current or future products; uncertainties related to insurance coverage and reimbursement status of newly approved products; manufacturing risks and supply chain disruptions; competition from other therapies or products; and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the Company's future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx's products and product candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2025, and its subsequent periodic reports filed with the SEC. In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx's Investor Relations website ( and LinkedIn website ( ContactsUltragenyx Pharmaceutical Higa+1-415-475-6370ir@ MediaJoey Fleury+1-925-784-5829media@
Yahoo
09-06-2025
- Business
- Yahoo
FDA approves YolTech's YOLT-101 for familial hypercholesterolemia
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). YOLT-101 is an in vivo base editing therapy designed to target proprotein convertase subtilisin/kexin type 9 (PCSK9). Its innovative approach lies in its potential to durably reduce blood low-density lipoprotein cholesterol (LDL-C) levels through a single-dose treatment. The technology behind YOLT-101 incorporates YolTech's adenine base editor, known as hpABE5, which consists of nCas and a new deaminase evolved from Hafnia paralvei. To deliver this therapeutic agent, the company employs an advanced lipid nanoparticle (LNP) delivery system. hpABE5 can perform precise A•T to G•C base conversions without inducing DNA double-strand breaks, thus minimising risks associated with chromosomal abnormalities and off-target effects. YolTech Therapeutics co-founder and CEO Yuxuan Wu stated: 'The FDA IND clearance marks a significant milestone for YolTech. In vivo gene editing represents a new generation of therapeutics — offering one-time, durable solutions for chronic and genetic diseases. 'We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients living with severe genetic and cardiovascular diseases.' Currently under evaluation in an ongoing investigator-initiated trial (IIT), YOLT-101 has shown promising results with a favourable safety profile and substantial LDL-C–lowering effects. Familial hypercholesterolemia is a genetic disorder stemming from mutations affecting LDL metabolism-related genes such as LDLR, Apolipoprotein B (APOB) and PCSK9. Individuals suffering from FH typically experience elevated LDL-C levels, which contribute to a heightened risk of developing early-onset atherosclerotic cardiovascular diseases. "FDA approves YolTech's YOLT-101 for familial hypercholesterolemia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
09-06-2025
- Business
- Yahoo
FDA approves YolTech's YOLT-101 for familial hypercholesterolemia
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). YOLT-101 is an in vivo base editing therapy designed to target proprotein convertase subtilisin/kexin type 9 (PCSK9). Its innovative approach lies in its potential to durably reduce blood low-density lipoprotein cholesterol (LDL-C) levels through a single-dose treatment. The technology behind YOLT-101 incorporates YolTech's adenine base editor, known as hpABE5, which consists of nCas and a new deaminase evolved from Hafnia paralvei. To deliver this therapeutic agent, the company employs an advanced lipid nanoparticle (LNP) delivery system. hpABE5 can perform precise A•T to G•C base conversions without inducing DNA double-strand breaks, thus minimising risks associated with chromosomal abnormalities and off-target effects. YolTech Therapeutics co-founder and CEO Yuxuan Wu stated: 'The FDA IND clearance marks a significant milestone for YolTech. In vivo gene editing represents a new generation of therapeutics — offering one-time, durable solutions for chronic and genetic diseases. 'We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients living with severe genetic and cardiovascular diseases.' Currently under evaluation in an ongoing investigator-initiated trial (IIT), YOLT-101 has shown promising results with a favourable safety profile and substantial LDL-C–lowering effects. Familial hypercholesterolemia is a genetic disorder stemming from mutations affecting LDL metabolism-related genes such as LDLR, Apolipoprotein B (APOB) and PCSK9. Individuals suffering from FH typically experience elevated LDL-C levels, which contribute to a heightened risk of developing early-onset atherosclerotic cardiovascular diseases. "FDA approves YolTech's YOLT-101 for familial hypercholesterolemia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
05-06-2025
- Business
- Yahoo
NewAmsterdam Pharma to Host R&D Day on June 11, 2025
NAARDEN, The Netherlands and MIAMI, June 05, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or 'NewAmsterdam' or the 'Company'), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ('CVD') with elevated low-density lipoprotein cholesterol ('LDL-C'), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will host an R&D Day event for analysts and investors on June 11, 2025 beginning at 9:00 a.m. ET in New York City. Please join members of our management team, including: Michael Davidson, M.D., Chief Executive Officer, John Kastelein, M.D., Ph.D., FESC, Founder and Chief Scientific Officer, BJ Jones, Chief Commercial Officer, Ian Somaiya, Chief Financial Officer, and Matthew Philippe, Executive Vice President. A live webcast of the R&D event will be available and those who intend to join virtually can pre-register for the webcast through the link here. The live webcast and supporting presentation materials will be available on the Events section of the Investor Relations page of the NewAmsterdam website at at the time of the live event. An archived replay will be available on the NewAmsterdam website. Please note advanced registration is required for in-person attendance. About ObicetrapibObicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About NewAmsterdamNewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: Media ContactSpectrum Science on behalf of NewAmsterdamJaryd LeadyP: 1-856-803-7855jleady@ Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP:
