Questions around the use of female hormone replacement therapy for years have kept women on the fence about these treatments. But in a new Wall Street Journal opinion piece, FDA Commissioner Dr. . Marty McCary says that it is time for drug manufacturers to remove blackbox warnings from these products because they've inappropriately scared women off.FDA Commissioner Dr. . Marty McCary joins us this morning to go more in depth on this. And Commissioner, thank you for being here today.Um, this is a a really bi ...

Financial Performance - Total revenue for Q3 2025 reached $87.3 million, a 69% year-over-year increase[7, 31] - U S net product sales for Q3 2025 were $40.7 million, representing a 31% year-over-year growth[7, 31] - Collaboration revenue increased by 128% year-over-year, reaching $46.7 million in Q3 2025[31] - Esperion closed a $75 million follow-on equity offering, resulting in net proceeds of approximately $72.6 million[31] Market Access and Expansion - Retail prescription equivalents increased by 9% quarter-over-quarter[8, 39] - The total prescriber base now exceeds 30,000 healthcare professionals[10] - Medicare coverage reached 87% and commercial coverage reached 86%[13] Guideline Recognition and Strategic Partnerships - Bempedoic acid received a Level 1a recommendation in the updated ESC/EAS Guidelines for Management of Dyslipidemia[8, 15] - Esperion has partnerships in over 40 countries globally, including Europe, Japan, Asia, South America, Israel, Australia & New Zealand, and Canada[19] Pipeline and Future Outlook - Triple Combination A and B are projected to have NDA filings in 2027[25] - The company expects market approval in Canada in Q4 2025[19]

Core Insights - NewAmsterdam Pharma is focused on advancing obicetrapib, a novel oral therapy for lowering LDL-C in patients at risk of cardiovascular disease, with recent regulatory milestones achieved in Europe [2][7][11] Clinical Development Updates - The European Medicines Agency has accepted marketing authorization applications for obicetrapib and its fixed-dose combination with ezetimibe, marking a significant regulatory milestone [2][7] - Ongoing clinical trials include PREVAIL, a cardiovascular outcomes trial with over 9,500 patients enrolled, and REMBRANDT, a Phase 3 imaging trial [9][11] - Recent data from the BROADWAY trial indicates obicetrapib's potential to modify Alzheimer's disease biomarkers, particularly in high-risk patients [5][13] Financial Performance - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities totaling $756.0 million, a decrease from $834.2 million at the end of 2024 [10][21] - Revenue for the third quarter of 2025 was $0.3 million, down from $29.1 million in the same period in 2024, primarily due to the absence of clinical milestone revenue [10][23] - Research and development expenses decreased to $31.0 million from $35.7 million year-over-year, while selling, general, and administrative expenses increased to $24.5 million from $18.4 million [10][23] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals despite existing treatments [12][14] - The company aims to address this gap with obicetrapib, which has shown promising results in clinical trials, indicating its potential as a differentiated therapy in a growing market [2][11]

Oral Microbiome & Cardiovascular Health - Oral microbiome, extending from the nose to the anus, is specific and can predict cardiovascular disease risk [1] - Poor oral hygiene and bad oral bacteria are unequivocally linked to valvular diseases like aortic stenosis and premature calcification of the aortic valve, as well as coronary calcification [2] - Chronic sinusitis, especially fungal sinusitis, causes low-grade inflammation and is linked to coronary artery disease [3] Coronary Artery Disease (CAD) - The definition of the causes of CAD is evolving beyond traditional factors [4] - Lifestyle factors, including mental, physical, and dietary aspects, significantly impact coronary arteries [4]

Core Insights - NewAmsterdam Pharma is advancing its oral, low-dose CETP inhibitor obicetrapib, targeting cardiovascular disease and Alzheimer's pathology, with significant clinical data supporting its efficacy [3][4][10] - The company reported a substantial increase in revenue for Q2 2025, recognizing $19.1 million compared to $2.3 million in Q2 2024, primarily due to development cost contributions from Menarini [7][19] - NewAmsterdam's cash position as of June 30, 2025, was $783.3 million, down from $834.2 million at the end of 2024, reflecting ongoing operating expenditures [7][19] Clinical Development Updates - The PREVAIL Phase 3 cardiovascular outcomes trial has completed enrollment of over 9,500 patients, focusing on those with a history of ASCVD [9][10] - Positive topline data from the BROADWAY trial indicated a statistically significant reduction in p-tau217 levels, a key Alzheimer's biomarker, in patients treated with obicetrapib [4][12] - The company plans to launch the Phase 3 RUBENS trial later in 2025, evaluating obicetrapib in combination with ezetimibe for patients with type 2 diabetes and metabolic syndrome [3][4] Financial Performance - NewAmsterdam reported a net loss of $17.4 million for Q2 2025, an improvement from a net loss of $39.0 million in Q2 2024 [7][19] - Research and development expenses decreased to $27.5 million in Q2 2025 from $38.4 million in the same period in 2024, attributed to reduced clinical expenses [7][19] - Selling, general, and administrative expenses rose to $27.3 million in Q2 2025, up from $16.5 million in Q2 2024, driven by increased personnel costs and marketing investments [7][19] Market Context - Cardiovascular disease remains a leading global health issue, with a projected increase in affected U.S. adults to over 184 million by 2050, highlighting the need for effective LDL-C lowering therapies [11] - Despite the availability of lipid-lowering therapies, many patients remain undertreated, with only 10% of very high-risk ASCVD patients achieving LDL-C goals below 55 mg/dL [11] - The company aims to address this unmet need with obicetrapib, which has shown promising LDL-C reduction and a favorable safety profile in clinical trials [10][11]

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]