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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), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients, has announced the approval of inducement share options. The Compensation Committee granted options for 97,600 ordinary shares to two non-executive new hires at an exercise price of $17.82 per share. The options will vest over four years, with 25% vesting after one year and the remaining balance vesting in 36 monthly installments. These grants were made under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma (Nasdaq: NAMS) has announced its participation in two major conferences this November. The company will present new safety and efficacy data from their Phase 3 BROOKLYN study of obicetrapib at the 2024 American Heart Association Scientific Sessions in Chicago (November 16-18). The study focuses on patients with Heterozygous Familial Hypercholesterolemia.
Additionally, the company's management will participate in the Jefferies London Healthcare Conference (November 19-21). Dr. Stephen Nicholls will present the BROOKLYN study findings on November 18, while CEO Michael Davidson, CSO John Kastelein, and CFO Ian Somaiya will lead a fireside chat on November 21. A live webcast of the Jefferies presentation will be available on the company's investor relations website.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C, has announced the approval of inducement share options. The Compensation Committee of NewAmsterdam's Board of Directors granted options covering 100,000 ordinary shares to one non-executive new hire.
The share options, granted under the 2024 Inducement Plan, have an exercise price of $17.29 per share, equal to the closing market price on October 1, 2024. The shares will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 equal monthly installments, subject to continued service. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company, has announced the approval of inducement share options for three new non-executive hires. The Compensation Committee of NewAmsterdam's Board of Directors granted options covering 111,000 ordinary shares under the 2024 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4).
The share options have an exercise price of $15.91 per share, matching the closing market price on September 3, 2024. The vesting schedule spans four years, with 25% vesting after one year and the remainder vesting in 36 equal monthly installments, contingent on continued employment. These grants are part of NewAmsterdam's strategy to attract talent in its mission to develop oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C.
NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin treatments for cardiovascular disease (CVD) patients with high LDL-C, announced its participation in upcoming investor conferences in September.
Management will attend the Morgan Stanley 22nd Annual Global Healthcare Conference in New York City on September 5-6, 2024. CFO Ian Somaiya will meet 1x1 with investors on September 5th and participate in a fireside chat on September 6th at 10:00 a.m. ET.
The company will also be present at the Cantor Global Healthcare Conference in New York City on September 17, 2024. CEO Michael Davidson, M.D., and CFO Ian Somaiya will participate in a fireside chat at 3:40 p.m. ET.
Live webcasts of both events will be available on the NewAmsterdam Pharma investor relations page, with replays accessible afterward.
NewAmsterdam Pharma reported positive topline data from its Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH, achieving the primary endpoint of LDL-C reduction. The company extended US IP protection for obicetrapib into 2043 with a new composition of matter patent. Enrollment for the Phase 3 TANDEM trial evaluating a fixed-dose combination of obicetrapib and ezetimibe was completed, with topline data expected in Q1 2025. NewAmsterdam maintains a strong financial position with $430.7 million in cash. The company reported Q2 2024 financial results, including revenue of $2.3 million, R&D expenses of $38.4 million, and a net loss of $39.0 million. Upcoming milestones include topline data from the Phase 3 BROADWAY trial in Q4 2024.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with elevated LDL-C, has announced the grant of inducement share options to a new non-executive hire. The Compensation Committee approved options for 59,200 ordinary shares under the 2024 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4).
The options have an exercise price of $17.25 per share, matching the closing market price on August 1, 2024. The shares will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments, subject to continued employment. This grant is part of NewAmsterdam's strategy to attract and retain key talent in its mission to develop innovative cardiovascular treatments.
Menarini Group announces positive topline data from the Phase 3 BROOKLYN clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH). The trial met its primary endpoint, achieving a 36.3% reduction in LDL-C at week 12 and 41.5% reduction at week 52 compared to placebo (p<0.0001). Over 50% of patients achieved LDL-C levels below 70 mg/dl. Obicetrapib was well-tolerated with no increase in blood pressure and fewer treatment-related adverse events than placebo. The BROOKLYN trial is part of obicetrapib's global Phase 3 program, which includes four studies with over 12,250 patients. These results suggest obicetrapib could be a new, high-efficacy, oral option for difficult-to-treat HeFH patients.
NewAmsterdam Pharma (Nasdaq: NAMS) announced positive topline data from its Phase 3 BROOKLYN clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH). The trial met its primary endpoint, achieving a 36.3% reduction in LDL-C compared to placebo at day 84 (p<0.0001), which was sustained at 41.5% reduction at day 365 (p<0.0001). Obicetrapib was observed to be well-tolerated with safety results comparable to placebo and no increase in blood pressure. The treatment discontinuation rate for obicetrapib was 7.6% versus 14.4% for placebo. The trial involved 354 patients randomized 2:1 to receive 10 mg obicetrapib or placebo once daily. These results support obicetrapib's potential to significantly reduce LDL-C in a challenging patient population over one year.
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.
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