Business
NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results
-- Reported positive topline data from pivotal Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH; achieved primary endpoint of LS mean
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Reported positive topline data from pivotal Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH; achieved primary endpoint of LS mean reduction in LDL-C versus placebo, as well as statistically significant reductions in other biomarkers, with safety results comparable to placebo – -- Extended US IP protection into 2043 with a new composition of matter patent -- -- On-track to report topline data from pivotal Phase 3 BROADWAY trial in 4Q 2024 – -- Completed enrollment of pivotal Phase 3 TANDEM trial evaluating fixed-dose combination of obicetrapib and ezetimibe; topline data expected in 1Q 2025 -- -- Strong financial position; $430.7 million in cash -- NAARDEN, the Netherlands and MIAMI, Aug. 07, 2024 (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 of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the three and six months ended June 30, 2024. “I am extremely pleased with our execution over the first half of 2024 and continue to be motivated by the team’s relentless commitment to unlocking the value of obicetrapib. We were thrilled to recently announce positive and statistically significant topline data from the pivotal Phase 3 BROOKLYN trial, which targeted heterozygous familial hypercholesterolemia (“HeFH”), a historically difficult-to-treat patient population, and underscores obicetrapib’s potential to address the significant unmet need for lipid lowering therapies,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Results from BROOKLYN achieved LDL-C lowering consistent with our phase 2 studies, along with a safety profile comparable to placebo, and with over half of patients on obicetrapib achieving the LDL-C guideline directed treatment goal of less than 70 mg/dl, we believe obicetrapib has potential to improve patient care for those living with dyslipidemia.” \"In addition, we recently hosted an R&D Day event where we detailed the differentiated target product profile of obicetrapib, discussed our commercial strategy, and unveiled REMBRANDT, a Phase 3 clinical s...