NewAmsterdam Pharma Company N.V Stock Price, News & Analysis

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.

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.