Business
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results
– EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"– EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11th, 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam,” “we,” 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, today announced financial results for the quarter ended March 31, 2025 and provided a corporate update. \"Our first quarter was marked by continued clinical execution and investment in our commercial organization to support the potential launch of obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “With over $800 million in cash, cash equivalents and marketable securities on our balance sheet, we believe we are well positioned to drive near- and long-term value for our stakeholders, as we move closer to delivering novel, once-daily, low dose, oral therapies to address the significant global unmet need for safe and effective LDL-C lowering therapies.” Dr. Davidson continued, “In addition, the data recently presented at EAS and published in the New England Journal of Medicine and The Lancet highlight obicetrapib’s differentiated product profile for the potential treatment of lipid management, and we are eager to continue to share additional data from our three pivotal Phase 3 trials, particularly regarding obicetrapib’s impact on major adverse cardiac events (“MACE”), at prominent medical conferences and journal publications. We are also progressing with regulatory interactions, including an expected EMA submission in the second half of the year by our partner Menarini. This commercial and clinical progress, combined with our financial strength provides a foundation for future growth as we look to address the needs of many more patients living with dyslipidemia.” Clinical...