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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 (NAMS) reported its full year 2024 financial results and corporate updates. The company highlighted positive results from three Phase 3 trials for obicetrapib, their oral non-statin medicine for cardiovascular disease patients with elevated LDL-C. The BROADWAY trial showed 33% LDL-C reduction, TANDEM trial achieved 49% reduction, and BROOKLYN trial demonstrated 36% reduction compared to placebo.
Financial highlights include $834.2 million in cash and marketable securities, revenue of $45.6 million (up from $14.1M in 2023), R&D expenses of $151.4 million, and net loss of $241.6 million. The company secured patent protection for obicetrapib until 2043 and expects EMA submission in 2H25 through partner Menarini.
NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company developing oral, non-statin medicines for patients with elevated LDL-C and cardiovascular disease risk, has announced its participation in multiple investor conferences in March 2025.
The company will attend the TD Cowen 45th Annual Healthcare Conference in Boston on March 4-5, where CEO Michael Davidson and CFO Ian Somaiya will present a corporate overview on March 4 at 1:50 p.m. ET.
Additionally, NAMS will participate in the Leerink Partners Global Healthcare Conference in Miami on March 10, with Dr. Davidson presenting at 8:00 a.m. ET, and the Jefferies Biotech on the Beach Summit in Miami on March 12, where management will be available for one-on-one meetings.
Live webcasts of the presentations will be accessible through the investor relations section of the company's website, with archived replays available afterward.
NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee has approved inducement share options for four non-executive new hires. The grants cover 138,000 ordinary shares under the company's 2024 Inducement Plan, complying with Nasdaq Listing Rule 5635(c)(4).
The share options were granted at an exercise price of $21.36, matching the closing market price of NAMS ordinary shares on February 3, 2025. The vesting schedule spans four years, with 25% vesting after one year and the remaining shares vesting in 36 equal monthly installments, contingent on continued employment.
NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with elevated LDL-C, has announced its participation in the Guggenheim SMID Cap Biotech Conference.
The company's Chief Financial Officer, Ian Somaiya, will engage in a fireside chat on Wednesday, February 5, 2025, at 10:00 a.m. ET. Investors and interested parties can access the live webcast through NewAmsterdam Pharma's investor relations website at ir.newamsterdampharma.com. An archived replay will be available on the company's website following the live presentation.
NewAmsterdam Pharma (NAMS) provided updates on its obicetrapib clinical development program and 2025 strategic priorities. The company reported positive topline results from three Phase 3 trials in 2024: BROADWAY showed 33% LDL-C reduction and 21% MACE reduction; TANDEM achieved 49% LDL-C reduction with fixed-dose combination; and BROOKLYN demonstrated 36% LDL-C reduction.
The company completed enrollment of over 9,500 patients in the PREVAIL cardiovascular outcomes trial. Additional data from these trials will be presented throughout 2025, supporting global regulatory filings including EMA submission in 2H25. The Phase 2 VINCENT trial, exploring obicetrapib's effect on Lp(a), is expected to report data in 2H25.
NewAmsterdam ended 2024 with an unaudited cash balance of $835 million following an oversubscribed public offering. The company secured patent protection for obicetrapib until July 2043 and is focusing on commercial readiness with manufacturing capacity establishment.
NewAmsterdam Pharma (Nasdaq: NAMS) announced the approval of inducement grants by its Board's Compensation Committee. The grants include share options for 58,000 ordinary shares to two non-executive new hires and 170,800 ordinary shares to Maryellen McQuade, the new Chief People Officer, at an exercise price of $25.94 per share.
The share options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments. Additionally, McQuade received 36,600 restricted stock units that will vest over three years, with one-third vesting annually. These grants were made under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma (NAMS) has successfully closed its upsized public offering, raising $479.0 million through the sale of securities. The offering included 14,667,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The underwriters fully exercised their option to purchase an additional 2,550,000 ordinary shares.
After deducting underwriting discounts, commissions, and estimated offering expenses, the company received net proceeds of approximately $452.6 million. The offering was conducted through multiple joint book-running managers, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair.
NewAmsterdam Pharma (NAMS) has announced the pricing of its upsized public offering, consisting of 12,117,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The offering is expected to generate approximately $416.5 million in proceeds before deducting expenses.
The company has granted underwriters a 30-day option to purchase up to an additional 2,550,000 ordinary shares. The offering is expected to close around December 13, 2024. Multiple investment banks, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair, are acting as joint book-running managers.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced the commencement of a $300 million public offering of ordinary shares and pre-funded warrants. The company is offering investors the choice between ordinary shares and pre-funded warrants to purchase ordinary shares. Additionally, underwriters will receive a 30-day option to purchase up to an additional $45 million of ordinary shares.
The offering will be conducted through multiple joint book-running managers including Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair. The offering will be made pursuant to a registration statement on Form S-3 that was declared effective by the SEC on July 12, 2024.
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.
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