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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated LDL-C. News about NewAmsterdam frequently centers on the clinical and regulatory progress of its lead investigational CETP inhibitor, obicetrapib, and related fixed-dose combination programs with ezetimibe.
Investors and clinicians following NAMS news can expect regular updates on NewAmsterdam’s Phase 3 development program, including the PREVAIL cardiovascular outcomes trial in patients with a history of atherosclerotic cardiovascular disease, the REMBRANDT imaging trial evaluating effects on coronary plaque and inflammation, and the RUBENS trial in patients with type 2 diabetes or metabolic syndrome who require additional LDL-C lowering. Press releases also cover pooled efficacy and safety data from pivotal trials such as BROOKLYN, BROADWAY and TANDEM, as presented at major cardiology and neurology conferences and in peer-reviewed journals.
Company news additionally includes regulatory milestones, such as acceptance of marketing authorization applications for obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination by the European Medicines Agency, as well as partnership activities with the Menarini Group in Europe and collaborations like the REMBRANDT imaging partnership with Caristo Diagnostics. Corporate updates on financial results, cash position, and equity-based inducement grants under Nasdaq Listing Rule 5635(c)(4) are also disclosed through press releases and SEC filings.
By monitoring NewAmsterdam Pharma news, readers can follow the evolution of obicetrapib’s clinical evidence in LDL-C lowering, cardiovascular outcomes, coronary plaque imaging and Alzheimer’s disease biomarkers, along with the company’s progress toward potential commercialization pathways and ongoing engagement with the investment and medical communities.
NewAmsterdam Pharma announced positive topline data from its Phase 3 BROADWAY clinical trial evaluating obicetrapib in patients with cardiovascular disease and heterozygous familial hypercholesterolemia. The trial achieved its primary endpoint with a statistically significant 33% reduction in LDL-C compared to placebo (p<0.0001).
Key findings include a 21% reduction in major adverse cardiovascular events favoring obicetrapib at one year. The drug demonstrated favorable safety results comparable to placebo, with treatment discontinuation rates of 11.1% for obicetrapib versus 12.4% for placebo. The trial involved 2,530 patients randomized 2:1 to receive 10mg obicetrapib or placebo daily for 52 weeks.
NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee approved inducement share options for 79,000 ordinary shares to two non-executive new hires. The options, granted under the 2024 Inducement Plan and compliant with Nasdaq Rule 5635(c)(4), have an exercise price of $19.64 per share, based on the December 2, 2024 closing price. The shares will vest over four years, with 25% vesting after one year and the remaining vesting monthly over 36 months, contingent on continued employment.
NewAmsterdam Pharma (NAMS) announced positive topline data from its Phase 3 TANDEM clinical trial evaluating a fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg. The trial met all co-primary endpoints, demonstrating a significant 48.6% LDL-C reduction compared to placebo at day 84 (p<0.0001). Over 70% of patients achieved LDL-C levels below 55 mg/dL. The drug combination was well-tolerated with safety results consistent with previous studies. The trial included 407 patients with HeFH and/or ASCVD or ASCVD risk factors, with results supporting global regulatory filings for the fixed-dose combination therapy.
Frazier Life Sciences (FLS) has appointed John Smither and Jim Williams as Senior Advisors. Smither brings over 25 years of biopharmaceutical financial experience, having served as CFO at companies including Arcutis Biotherapeutics, where he led their IPO and follow-on financings. He currently serves on the boards of NewAmsterdam Pharma (NAMS) and Genlux Williams contributes 35 years of investment strategy expertise, previously serving as Chief Investment Officer for the J. Paul Getty Trust and President of Harbor Capital Advisors. Both advisors will support FLS's private and public investment strategies in innovative therapeutics.
NewAmsterdam Pharma announced additional results from its Phase 3 BROOKLYN trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia. The trial met its primary endpoint with LDL-C mean reduction of 36.3% at day 84 and 41.5% at day 365 versus placebo. Secondary endpoints showed significant improvements, including Lp(a) reduction of 45.9% at day 84 and 54.3% at day 365, and total LDL-P reduction of 52.5% at day 180. The drug demonstrated a favorable safety profile comparable to placebo, with a lower discontinuation rate (7.6%) compared to placebo (14.4%). The study involved 354 patients randomized 2:1 to receive 10 mg obicetrapib or placebo.
NewAmsterdam Pharma (NAMS) reported Q3 2024 financial results and corporate updates. The company expects topline data from the pivotal Phase 3 TANDEM trial in Q4 2024, earlier than planned due to faster enrollment. Cash position strengthened to $422.7 million as of September 30, 2024. Q3 revenue increased to $29.1 million, up from $2.9 million in Q3 2023. R&D expenses decreased to $35.7 million from $43.4 million year-over-year, while SG&A expenses increased to $18.4 million from $9.1 million. Net loss improved to $16.6 million compared to $47.1 million in Q3 2023.
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.