NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

Rhea-AI Summary

NewAmsterdam Pharma (NAMS) and partner Menarini have received European Commission marketing authorization for Ubeslo (10 mg obicetrapib monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe), the first global regulatory approval of obicetrapib, for adults with primary hypercholesterolaemia, including heterozygous familial, and mixed dyslipidaemia.

The approval is based on Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with the fixed-dose combination versus placebo, with tolerability comparable to placebo. Under an exclusive European licensing agreement, Menarini will handle regulatory and commercial activities, while NewAmsterdam is eligible for tiered double-digit royalties on net sales in Europe and up to an additional €833 million tied to clinical, regulatory and commercial milestones. Multiple Phase 3 trials, including the PREVAIL cardiovascular outcomes study with over 9,500 patients enrolled, remain ongoing.

Positive

• First global approval of obicetrapib via EC authorization of Ubeslo and Evlarco
• Phase 3 data showed LDL-C reductions up to 40% (monotherapy) and ~50% (combo) versus placebo
• Exclusive Menarini deal in Europe with tiered double-digit royalties on net sales for NewAmsterdam
• Potential additional milestone payments up to €833 million tied to clinical, regulatory and commercial goals
• PREVAIL cardiovascular outcomes trial fully enrolled with over 9,500 patients, supporting longer-term value potential

Negative

• None.

Market Context

Before publication, NAMS closed at $22.49; the Aug 5 positive CHMP opinion had been followed by a 0....

Analysis

Before publication, NAMS closed at $22.49; the Aug 5 positive CHMP opinion had been followed by a 0.47% decline, a directly comparable regulatory-step reaction to this EC authorization.

Key Figures

European Commission authorization: 2 products Monotherapy LDL-C reduction: up to 40% Combination LDL-C reduction: approximately 50% +3 more

European Commission authorization

2 products

Ubeslo monotherapy and Evlarco fixed-dose combination

Monotherapy LDL-C reduction

up to 40%

Phase 3 trials versus placebo

Combination LDL-C reduction

approximately 50%

Obicetrapib plus ezetimibe versus placebo

Tiered royalties

low double-digits to mid-twenties

Percentage royalties on net sales in Menarini’s territory

Additional milestones

up to €833 million

Clinical, regulatory and commercial milestones

PREVAIL enrollment

over 9,500 patients

Phase 3 cardiovascular outcomes trial

Historical Context

1 past event · Latest: Aug 05

1 event

1. Aug 05

   Regulatory opinion

   24h Move

   -0.5%

   Positive CHMP opinion recommended EU authorization; final European Commission decision expected later in 2026.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ldl-c, cetp inhibitor, fixed-dose combination, chmp, +1 more

5 terms

ldl-c medical

"significant LDL-C reductions with favorable tolerability profile"

LDL-C stands for low-density lipoprotein cholesterol, the portion of cholesterol carried in the blood by LDL particles that is commonly linked to buildup of plaque in arteries—think of it like sticky debris that can clog pipes. Investors care because changes in LDL-C are a key measure used by regulators and clinicians to judge the effectiveness of cardiovascular drugs and devices, shape insurance coverage, and influence market demand for treatments that lower heart attack and stroke risk.

cetp inhibitor medical

"a novel, oral, low-dose CETP inhibitor"

A CETP inhibitor is a medicine that blocks a blood protein responsible for moving cholesterol between different carriers, which typically raises “good” HDL cholesterol and can lower “bad” LDL cholesterol. For investors, these drugs matter because if clinical trials and regulators confirm they reduce heart disease, they can create large new revenue streams for developers; conversely, trial failures or safety concerns can sharply reduce a company’s value, like a promising new tool that must still prove it fixes the problem.

fixed-dose combination medical

"10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination"

A fixed-dose combination is a single medication that contains two or more active drugs combined in set proportions, like a combo meal that packages complementary items into one order. For investors it matters because such products can improve patient convenience and adherence, streamline manufacturing and marketing, and create distinct regulatory and patent opportunities or risks that affect a drug’s market size, pricing power, and long-term revenue potential.

chmp regulatory

"European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)"

The CHMP is the European Medicines Agency’s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker’s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.

mace medical

"reduce occurrences of Major Adverse Cardiovascular Events (“MACE”)"

MACE stands for Major Adverse Cardiovascular Events — a composite medical endpoint that counts serious heart-related outcomes such as heart attack, stroke and cardiovascular death. Investors use MACE as a single safety and efficacy yardstick for drugs or devices aimed at the heart or blood vessels; like a vehicle crash-test score, a lower MACE rate signals fewer serious harms and can strongly influence regulatory approval, market adoption and commercial value.

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- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile-

- First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C -

NAARDEN, The Netherlands and MIAMI and FLORENCE, Italy, Sept. 21, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, along with partner Menarini Group (“Menarini”), today announced that the European Commission (EC) has granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolaemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide.

"The European Commission approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. "This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine. Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world."

The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo. NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS.

“This approval represents an important advancement for patients across Europe who require additional LDL-C lowering despite available therapies," said Elcin Barker Ergun, Chief Executive Officer of Menarini Group. "We are proud to reach this significant achievement alongside NewAmsterdam and look forward to leveraging our well-established commercial capabilities and deep cardiovascular expertise to bring Ubeslo and Evlarco to healthcare providers and eligible patients throughout Europe.”

Under the parties' licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region. NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.

For full details on the approved indications, contraindications, warnings, and precautions please refer to the Summary of Product Characteristics (SmPC) which will be made available on the European Medicines Agency websites at:
https://www.ema.europa.eu/en/medicines/human/EPAR/ubeslo
https://www.ema.europa.eu/en/medicines/human/EPAR/evlarco

About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of Major Adverse Cardiovascular Events (“MACE”). The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.

About Cardiovascular Disease
Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes.

About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to build a new standard of care for people living with cardiometabolic disease. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose.

About Menarini Group
The Menarini Group, with headquarters in Florence, is present in 140 countries worldwide to date, with $5.5 billion in consolidated turnover and more than 17,000 employees. Menarini’s products are present in the most important treatment areas, including those of cardiometabolic, oncology, gastroenterology, diabetology, pneumology, and anti-inflammatory/analgesic products. Through its commitment to R&D and high-quality manufacturing activities, Menarini continuously contributes to patients’ health worldwide, maintaining the highest quality standards.

Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: the therapeutic potential of obicetrapib; expected availability of Ubeslo and Evlarco across Europe; the Company’s licensing agreement with Menarini and entitlement to potential future payments thereunder; the continued advancement of clinical development of obicetrapib through multiple ongoing Phase 3 trials; and other statements regarding the Company's future operations, prospects, objectives, strategies and other future events. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: whether projections regarding clinical outcomes will reflect actual results in clinical use of Ubeslo and Evlarco; risks related to the Company’s ability to achieve its business plans, objectives and milestones, including those related to its licensing agreement with Menarini; challenges inherent to the clinical development and launch of new drug products; risks related to the Company’s reliance on third parties; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, as well as in other filings the Company may make with the SEC in the future, which are available at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law.

BROADWAY (NCT05142722)
BROOKLYN (NCT05425745)
OCEAN: NCT04770389
PREVAIL (NCT05202509)
REMBRANDT (NCT06305559)
ROSE: NCT04753606
ROSE2: NCT05266586
RUBENS (NCT07219602)
TANDEM (NCT06005597)
TULIP: NCT01970215

Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com

Media Contact
Real Chemistry on behalf of NewAmsterdam
Christian Edgington
P: 1-513-310-6410
cedgington@realchemistry.com  

Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com  

Menarini Group Media Contact
Valeria Speroni Cardi
pressoffice@menarini.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What conditions are Ubeslo and Evlarco approved to treat in Europe?

Ubeslo and Evlarco are approved for adult patients with primary hypercholesterolaemia, both heterozygous familial (HeFH) and non-familial, or mixed dyslipidaemia, who require additional LDL-C lowering beyond existing therapies.

Which clinical trials supported the European approval of obicetrapib products?

The European Commission approval is supported by NewAmsterdam’s Phase 3 BROADWAY, BROOKLYN and TANDEM trials. These studies evaluated obicetrapib as monotherapy and in fixed-dose combination with ezetimibe and showed statistically significant LDL-C reductions versus placebo with a tolerability profile comparable to placebo.

What ongoing Phase 3 studies of obicetrapib are mentioned beyond the approved indications?

NewAmsterdam and Menarini continue development of obicetrapib in multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial designed to assess effects on Major Adverse Cardiovascular Events, as well as the REMBRANDT and RUBENS studies.

Where can healthcare professionals find full prescribing details for Ubeslo and Evlarco?

The companies state that full information on approved indications, contraindications, warnings and precautions will be available in the Summary of Product Characteristics (SmPC) on the European Medicines Agency website at: https://www.ema.europa.eu/en/medicines/human/EPAR/ubeslohttps://www.ema.europa.eu/en/medicines/human/EPAR/evlarco.

What commercial rights does Menarini hold for obicetrapib in Europe?

Under the licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe, both as monotherapy and as a fixed-dose combination with ezetimibe. Menarini is responsible for regulatory interactions and commercialization activities throughout the region, while NewAmsterdam receives royalties and may earn additional milestone payments.