NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NewAmsterdam Pharma Co N.V. (NAMS) filed an SEC Form 8-K — Results of Operations and Financial Condition. NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results – Announced positive CHMP opinion recommending marketing authorization for obicetrapib and obicetrapib/ezetimibe – – PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q20

NewAmsterdam Pharma (NAMS) and Menarini said the EMA CHMP issued a positive opinion for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for adults with primary hypercholesterolemia. CHMP based on Phase 3 BROADWAY, BROOKLYN and TANDEM; LDL-C fell up to 40% with monotherapy and about 50% with the combo vs placebo. European Commission decision expected H2 2026.

NewAmsterdam Pharma (Nasdaq: NAMS) and Menarini said the EMA CHMP issued a positive opinion recommending EU marketing authorization for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for primary hypercholesterolemia. The recommendation is based on Phase 3 BROADWAY, BROOKLYN, and TANDEM data showing LDL-C reductions up to 40% and about 50%. The European Commission decision is expected in 2H26.

NewAmsterdam Pharma (Nasdaq: NAMS) and Menarini said the EMA CHMP issued a positive opinion recommending marketing authorization in Europe for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for primary hypercholesterolemia. The recommendation is based on Phase 3 BROADWAY, BROOKLYN, and TANDEM results showing LDL-C reductions up to 40% and about 50%. European Commission decision expected in 2H26.

BioNTech (NASDAQ:BNTX) halted a mid-stage trial of its mRNA cancer vaccine, autogene cevumeran, due to an overall survival imbalance. The decision raises concerns about its mRNA strategy in colorectal cancer and other 'cold' tumors. BioNTech plans to continue other trials, including one for pancreatic cancer and BNT113 for head and neck cancer. The company also focuses on diversifying its oncology pipeline. According to Reuters, the news caused a 7.5% drop in BioNTech's US-listed shares.

Volkswagen (VW) plans to produce components for Israel's Iron Dome missile defense system at its Osnabrück, Germany factory. The move is part of VW's restructuring efforts amid economic challenges and competition. The project involves a joint venture with Israeli defense company Rafael and the German state of Lower Saxony, aiming to overcome opposition from Qatar's sovereign wealth fund, a VW stakeholder. This marks VW's return to defense-related manufacturing as European defense spending rises.