Welcome to our dedicated page for NewAmsterdam Pha news (Ticker: namsw), a resource for investors and traders seeking the latest updates and insights on NewAmsterdam Pha stock.
About NewAmsterdam Pharma
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to transforming patient care in the field of cardiovascular disease (CVD). With a focus on populations where existing therapies are insufficient or poorly tolerated, NewAmsterdam aims to address significant unmet medical needs through innovative, non-statin LDL-C lowering treatments.
Core Product: Obicetrapib
At the heart of NewAmsterdam’s development pipeline is obicetrapib, a next-generation, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor. Designed to overcome the limitations of current LDL-C lowering therapies, obicetrapib offers a once-daily, highly selective treatment option. It is being developed both as a monotherapy and in a fixed-dose combination with ezetimibe, targeting patients at risk of CVD who struggle to achieve LDL-C goals despite maximally tolerated statins or other lipid-lowering therapies.
Clinical Development Program
NewAmsterdam is conducting a comprehensive Phase 3 clinical development program involving over 12,250 patients worldwide. Key trials include:
- BROADWAY: Evaluates obicetrapib monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
- BROOKLYN: Focuses on LDL-C reduction in HeFH patients on maximally tolerated lipid-lowering therapy.
- TANDEM: Assesses the fixed-dose combination of obicetrapib and ezetimibe for LDL-C lowering in ASCVD and HeFH patients.
- PREVAIL: A cardiovascular outcomes trial (CVOT) designed to evaluate obicetrapib’s ability to reduce major adverse cardiovascular events (MACE).
These trials have demonstrated statistically significant LDL-C reductions and a safety profile comparable to placebo, positioning obicetrapib as a promising alternative for patients with limited options.
Market Position and Differentiation
NewAmsterdam operates in the highly competitive cardiovascular treatment market, which includes statins, PCSK9 inhibitors, and other lipid-lowering therapies. The company differentiates itself through its focus on CETP inhibition, offering a novel mechanism of action that addresses residual cardiovascular risk factors beyond LDL-C reduction, such as lipoprotein(a) and small LDL particles.
With robust intellectual property protection extending until 2043 and exclusive European commercialization rights granted to the Menarini Group, NewAmsterdam is strategically positioned to capture a significant share of the LDL-C lowering market.
Addressing Unmet Needs in CVD
Cardiovascular disease remains the leading cause of death globally, with millions of patients failing to achieve LDL-C targets despite available therapies. NewAmsterdam aims to bridge this gap by offering a safe, effective, and convenient oral treatment option. Obicetrapib’s potential to reduce LDL-C and improve cardiovascular outcomes could transform the treatment landscape for patients with ASCVD, HeFH, and other high-risk conditions.
Commitment to Innovation and Patient Care
NewAmsterdam’s mission is underpinned by a commitment to rigorous clinical research, operational excellence, and patient-centric innovation. By addressing critical gaps in CVD treatment, the company seeks to improve health outcomes for millions of patients worldwide.
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.
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.
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.
FAQ
What is the current stock price of NewAmsterdam Pha (namsw)?
What is NewAmsterdam Pharma's primary focus?
What is obicetrapib?
What clinical trials is NewAmsterdam conducting?
How does NewAmsterdam differentiate itself in the market?
What are the potential benefits of obicetrapib?
What is the significance of NewAmsterdam's intellectual property?
Who are NewAmsterdam's target patients?
What role does the Menarini Group play in NewAmsterdam's operations?
What unmet needs does NewAmsterdam address in cardiovascular disease?
What is CETP inhibition, and why is it important?
