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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a leading late-stage biopharmaceutical company headquartered in the Netherlands, dedicated to revolutionizing patient care for metabolic diseases. The company focuses on populations where existing therapies are insufficient or poorly tolerated. Central to NewAmsterdam's innovation is obicetrapib, a next-generation, oral, low-dose CETP inhibitor designed to address limitations of current LDL-C lowering treatments.
As of 2024, NewAmsterdam is at the forefront of clinical development, with multiple pivotal Phase 3 trials underway. The company is optimistic about its potential to transform cardiovascular disease (CVD) treatment. Recent milestones include the enrollment completion of the BROOKLYN and BROADWAY Phase 3 trials, both aimed at evaluating obicetrapib’s efficacy as an adjunct to maximally tolerated statin therapy. Additionally, the company's PREVAIL cardiovascular outcomes trial and the newly initiated TANDEM Phase 3 trial are progressing, assessing obicetrapib's combination with ezetimibe for patients with elevated LDL-C levels.
In 2023, NewAmsterdam reported promising outcomes from its Phase 2 trials, including the ROSE2 trial, which combined obicetrapib with ezetimibe, demonstrating a significant 63% reduction in LDL-C levels. The company's robust clinical pipeline showcases obicetrapib’s strong tolerability profile, having tested the drug in over 800 patients with elevated lipid levels and observing statistically significant results without severe adverse events.
Looking to the future, NewAmsterdam is well-positioned financially, forecasting sufficient cash runway through 2026 to support its ambitious development plans. The company is also actively preparing for the global launch of obicetrapib, pending necessary regulatory approvals. This includes strategic investments in its commercial organization to ensure comprehensive market readiness.
NewAmsterdam’s commitment to innovation is further reinforced by strong intellectual property protection for obicetrapib, with patents extending until July 2043. This robust IP portfolio underscores the company's dedication to maintaining a competitive edge in the biopharmaceutical industry.
For more information, visit NewAmsterdam Pharma Company’s investor relations page or contact their media and investor relations teams for the latest updates.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced it will report topline data from its Phase 3 BROOKLYN clinical trial (NCT05425745) on Monday, July 29, 2024. The trial evaluates obicetrapib in patients with heterozygous familial hypercholesterolemia. NewAmsterdam, a late-stage biopharmaceutical company, is developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C. The company will host a live webcast and conference call to review the results on July 29, 2024, at 8:30 a.m. ET. Participants can register for the webcast or telephone conference, and an archived replay will be available on the company's website.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced significant changes to its Board of Directors. Mark C. McKenna and Wouter Joustra have been appointed as temporary non-executive directors, while Sander Slootweg has departed. McKenna brings over 20 years of pharmaceutical industry experience, including leadership roles at Prometheus Biosciences and Salix Pharmaceuticals. Joustra, a General Partner at Forbion, contributes expertise in capital markets and life sciences investment.
These appointments come at a important time for NewAmsterdam, as the company approaches pivotal Phase 3 data readouts for its oral, non-statin medicines targeting cardiovascular disease patients with elevated LDL-C. The new directors are expected to provide valuable insights and support as NewAmsterdam aims to make a significant impact on the CVD landscape.
NewAmsterdam Pharma has completed enrollment for its pivotal Phase 3 TANDEM clinical trial, which evaluates a fixed-dose combination of obicetrapib and ezetimibe in patients with Heterozygous Familial Hypercholesterolemia (HeFH) or Atherosclerotic Cardiovascular Disease (ASCVD) or its risk factors. The trial includes 407 patients whose LDL-C levels are not adequately controlled despite existing therapies. The primary goal is to assess changes in LDL-C levels, with secondary goals focusing on lipoprotein(a), apolipoprotein B, and non-HDL-C.
Topline data is expected in Q1 2025. The trial is double-blind and placebo-controlled. This milestone aims to advance obicetrapib as a convenient, once-daily treatment for dyslipidemia, potentially improving health outcomes globally if approved.
NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee approved inducement share options for three new non-executive employees. A total of 195,000 ordinary shares were granted under the 2024 Inducement Plan, in line with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $20.58 per share, matching the closing price on July 1, 2024. The shares will vest over four years, starting with 25% on the one-year anniversary of the vesting commencement date, followed by 36 equal monthly installments, subject to continued employment.
NewAmsterdam Pharma announced that the United States Patent and Trademark Office (USPTO) has issued a new composition of matter patent for obicetrapib, extending its patent protection until July 2043. This patent covers amorphous obicetrapib hemicalcium, the solid form to be used in the company's products, and will be listed in the FDA's Orange Book if approved. The USPTO has issued or allowed nine patents for obicetrapib and its applications. CEO Michael Davidson highlighted that this new patent extends protection more than 9 years beyond the previous patent, facilitating ongoing Phase 3 trials and long-term benefits from obicetrapib's innovation.
NewAmsterdam Pharma (Nasdaq: NAMS), a biopharmaceutical company developing oral, non-statin medicines for cardiovascular disease (CVD) patients with elevated LDL-C, announced the approval of inducement share options for five new non-executive hires. The Compensation Committee granted options for a total of 90,000 ordinary shares under the 2024 Inducement Plan. These options, priced at $18.92 per share based on the June 3, 2024 market close, will vest over four years: 25% after one year and the remaining 75% in equal monthly installments over the next three years, contingent upon continued employment. The grants adhere to Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma, a late-stage clinical biopharmaceutical company developing non-statin medicines for cardiovascular disease patients with elevated LDL-C, announced its management's participation in two upcoming investor conferences.
On June 5, 2024, the company will attend the Jefferies Global Healthcare Conference in New York, where CEO Michael Davidson and CFO Ian Somaiya will engage in a fireside chat at 3:00 p.m. ET.
On June 10, 2024, CEO Michael Davidson will present a corporate overview at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach at 10:40 a.m. ET. Live webcasts of both events will be available on the company's investor relations website, with replays accessible post-event.
NewAmsterdam Pharma (Nasdaq: NAMS) announced it will present new clinical and preclinical data on obicetrapib, a novel oral therapy for hypercholesterolemia, at two major upcoming medical meetings. The data, derived from the OCEAN, ROSE, and ROSE2 Phase 2 trials, show obicetrapib's impact on key lipid and lipoprotein biomarkers. The presentations will occur at the European Atherosclerosis Society (EAS) 92nd Congress in Lyon, France, and the National Lipid Association (NLA) 2024 Scientific Sessions in Las Vegas, Nevada. The company is also on track to report topline data from its Phase 3 BROOKLYN trial in HeFH by Q3 2024 and its Phase 3 BROADWAY trial in ASCVD by Q4 2024.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) provides corporate updates and financial results for the first quarter of 2024. The company enrolled over 9,500 patients in Phase 3 trials, reported strong financial position with $481.1 million in cash, and is on track to report topline data from upcoming trials. NewAmsterdam continues to develop obicetrapib, focusing on improving LDL-C goals for patients at risk of cardiovascular disease.
NewAmsterdam Pharma Company N.V. announced the grant of inducement share options to three non-executive new hires under the 2024 Inducement Plan. The options cover 30,000 ordinary shares, with an exercise price of $21.97 per share. The shares will vest over four years, with 25% vesting after one year and the rest in monthly installments, contingent on continued service.
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