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EU panel backs NewAmsterdam and Menarini cholesterol drugs

Fri, 24 Jul 2026 08:00:14 -0400

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for two obicetrapib-based treatments developed by NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) and its partner Menarini Group.

The recommendation covers Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination) for patients with primary hypercholesterolemia, including heterozygous familial and non-familial forms, as well as mixed dyslipidemia.

The CHMP opinion is supported by data from the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials. Those studies showed LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo,

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Co

Fri, 24 Jul 2026 08:00:00 -0400

- Positive CHMP opinion supports potential commercialization of obicetrapib monotherapy and obicetrapib/ezetimibe fixed-dose combination in Europe -

- Recommendation based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM data -

- European Commission decision expected in 2H26 -

NAARDEN, The Netherlands and MIAMI and FLORENCE, Italy, July 24, 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

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Co

Fri, 24 Jul 2026 08:00:00 -0400

- Positive CHMP opinion supports potential commercialization of obicetrapib monotherapy and obicetrapib/ezetimibe fixed-dose combination in Europe -

- Recommendation based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM data -

- European Commission decision expected in 2H26 -

Form 4 NewAmsterdam Pharma Co For: Jul 20 Filed by: Kooij Louise Frederika

Wed, 22 Jul 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260722/26801626.html

Form 4 NewAmsterdam Pharma Co For: Jul 20 Filed by: Kooij Louise Frederika

Wed, 22 Jul 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260722/26801626.html

BMO Capital Starts NewAmsterdam Pharma Co NV (NAMS) at Outperform

Mon, 20 Jul 2026 16:36:54 -0400

BMO Capital initiates coverage on NewAmsterdam Pharma Co NV (NASDAQ: NAMS) with a Outperform rating and a price target of $58.00.

For an analyst ratings summary and ratings history on NewAmsterdam Pharma Co NV click here. For more ratings news on NewAmsterdam Pharma Co NV click here.

Shares of NewAmsterdam Pharma Co NV closed at $31.68 yesterday.

BMO Capital Starts NewAmsterdam Pharma Co NV (NAMS) at Outperform

Mon, 20 Jul 2026 16:36:54 -0400

BMO Capital initiates coverage on NewAmsterdam Pharma Co NV (NASDAQ: NAMS) with a Outperform rating and a price target of $58.00.

For an analyst ratings summary and ratings history on NewAmsterdam Pharma Co NV click here. For more ratings news on NewAmsterdam Pharma Co NV click here.

Shares of NewAmsterdam Pharma Co NV closed at $31.68 yesterday.

Jefferies Reiterates Buy Rating on NewAmsterdam Pharma Co NV (NAMS)

Mon, 20 Jul 2026 11:36:04 -0400

Jefferies analyst Dennis Ding reiterated a Buy rating and $45.00 price target on NewAmsterdam Pharma Co NV (NASDAQ: NAMS).

The analyst comments "Big Picture: NVS could report Phase III HORIZON data in Jul/Aug, one of the most closely watched cardio readouts this year given the pot'l to validate the Lp(a) biology but also readthrough to NAMS. Our deep dive last year (here) estimated an incremental +3-5% CV benefit for obicetrapib in PREVAIL if we assume NVS achieves ~20% CV benefit. But if NVS shows 10-15%, which is now our base case after a lower than expected event rate, the incremental MACE

Attovia Therapeutics names John Smither to board of directors