Cardiovascular Disease

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NewAmsterdam Pharma Company (NAMS) Earnings Call Presentation
2025-07-03 10:51
Clinical Program and Trial Results - NewAmsterdam Pharma completed enrollment for BROOKLYN, BROADWAY and PREVAIL Phase 3 studies[5] - The BROOKLYN Phase 3 trial, involving 354 participants with HeFH and LDL-C ≥70 mg/dL, has primary endpoint of LDL-C reduction at 12 weeks[46, 49] - The BROADWAY Phase 3 trial, involving 2,532 participants with ASCVD or HeFH and LDL-C ≥55 mg/dL, also has primary endpoint of LDL-C reduction at 12 weeks[46, 53] - The PREVAIL CVOT, involving 9,541 participants with ASCVD and LDL-C ≥55 mg/dL, has primary endpoint of 4-Point MACE+ with a minimum 30-month follow-up[46, 61] - Initial data from an Alzheimer's Disease sub-study showed that obicetrapib 10mg decreased 24s- & 27s-hydroxycholesterol in both plasma and cerebrospinal fluid in a phase 2a study (n=13)[55] Obicetrapib's Potential Benefits - Obicetrapib observed to lower small LDL-P by 90%+ and total particles by over 70% in combination with ezetimibe[24] - Obicetrapib 10 mg on top of high-intensity statins significantly lowered Lp(a) by 57% vs placebo, in ROSE[80] - Obicetrapib monotherapy observed a 43% mean LDL-C lowering[30] - Obicetrapib in combination with ezetimibe observed a 59% mean LDL-C lowering on top of high-intensity statins[31] Commercial Opportunity - Approximately 30 million+ patients in the US are not achieving LDL-C lowering goals despite standard-of-care[30] - The lipid-lowering therapy market has over 250 million prescriptions annually[164] - The market is growing at over 4% over the last 2 years, with the non-statin market growing at high double digits[164] Financial Position - NewAmsterdam Pharma had $481 million in cash as of 1Q24[225]
Esperion(ESPR) - 2022 Q1 - Earnings Call Presentation
2025-07-03 08:19
FORWARD-LOOKNG STATEMENTS & DISCLOSURES MAY 3, 2022 © 2022 Esperion. All Rights Reserved – For investor audience only WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing ...
Tiny Hearts and Big Answers | Dr. Eman Akam-Baxter | TEDxYouth@DoverSherbornHighSchool
TEDx Talks· 2025-07-02 16:40
Raise your hand if you've ever scraped your knee or maybe cut your finger on a sharp object or maybe burned your hand on a hot stove. Most of us, right. Your body does something amazing.It sends in a repair team that lays down a scab to stop the bleeding and then specialized cells digest or remove all of that dead or injured tissue and lay down a scar. Now imagine this. What happens if your heart gets injured.Does it just scab over. Let me tell you a story where healing is more than just bandages. where glo ...
CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication
ZACKS· 2025-06-24 17:01
Key Takeaways CHMP recommends updating Ozempic's EU label based on positive STRIDE PAD outcomes in T2D patients. Ozempic showed improved walking capacity in patients with T2D and PAD in the late-stage STRIDE study. NVO expects EC approval of the PAD label update within two months; FDA review is underway in the U.S.Novo Nordisk (NVO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly se ...
Amarin Announces Exclusive License and Supply Agreement with Recordati to Commercialize VAZKEPA® (Icosapent Ethyl) in Europe
Globenewswire· 2025-06-24 11:00
-- Company to Streamline Global Operations, Resulting in Approximately $70 Million of Cost Savings Over Next 12 Months and Accelerated Path to Positive Cash Flow -- Dr. Kostas continued, "We are pleased to place VAZKEPA, a drug with proven, meaningful cardiovascular benefit when added to statins, in the hands of a partner with the capabilities and experience in the cardiovascular space in Europe as Recordati. We believe this partnership for VAZKEPA positions both companies to benefit from future sales growt ...
AMGEN'S PHASE 2 MARITIDE DATA TO BE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS
Prnewswire· 2025-06-18 13:00
MariTide is the First Monthly or Less Frequently Dosed Peptide-Antibody Conjugate Being Investigated for the Treatment of Obesity and Type 2 Diabetes THOUSAND OAKS, Calif., June 18, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced full results from Part 1 of the Phase 2 study for MariTide (maridebart cafraglutide, formerly AMG 133) in patients living with obesity, with and without Type 2 diabetes, will be presented along with new data from the Phase 3 FOURIER study of Repatha® (evolocumab) in cardio ...
NewAmsterdam Pharma Company (NAMS) 2025 Earnings Call Presentation
2025-06-11 13:05
Welcome to R&D Day June 11, 2025 Disclaimer Forward Looking Statements Certain statements included in this presentation (together with oral statements made in connection herewith, this "Presentation") that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," ...
Veru to Participate in the Virtual BTIG Obesity Health Forum
Globenewswire· 2025-06-11 12:30
MIAMI, FL, June 11, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the company will be participating in one-on-one meetings and a fire side chat presentation with investors at the virtual BTIG Obesity Health Forum on June 18, 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative m ...
Amgen Inc. (AMGN) Presents at Goldman Sachs 46th Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-06-10 21:28
Amgen Inc. (NASDAQ:AMGN) Goldman Sachs 46th Annual Global Healthcare Conference Call June 10, 2025 9:20 PM ET Company Participants James E. Bradner - Executive Vice President of Research & Development Justin G. Claeys - Vice President of Investor Relations Peter H. Griffith - Executive VP & CFO Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you so much for joining us. I'm really pleased to have wi ...
CRISPR Therapeutics (CRSP) FY Conference Transcript
2025-06-09 20:22
Summary of Key Points from the Conference Call Company Overview - CRISPR Therapeutics has been operational for approximately eleven years, with a focus on developing gene editing therapies, particularly in the areas of cardiovascular medicine and autoimmune diseases [1][2] Core Products and Pipeline - **KASJEVY**: Approved for sickle cell disease and thalassemia, currently ramping up commercial uptake with over 65 authorized treatment centers activated globally [2][8] - **Cardiovascular Medicine**: Focus on gene editing therapies targeting ANGPTL3, showing nearly 80% reduction in LDL and triglycerides from a single injection [2][3][20] - **Autoimmune Diseases**: Development of allogeneic CAR T therapies, with plans to expand indications beyond lupus [3][4] Key Data and Results - **ANGPTL3 Targeting**: Initial data indicates a significant reduction in triglycerides and LDL, outperforming expectations and existing therapies [20][21] - **Gentler Preconditioning Regimens**: Development of gentler conditioning methods could expand the addressable market for KASJEVY by 3-4 times [15][17] Market Dynamics - The launch of KASJEVY is compared to medical devices rather than traditional pharmaceuticals, indicating a unique commercialization strategy [10][11] - The cardiovascular space is evolving with multiple modalities, including siRNA and gene editing, with a focus on long-term patient outcomes and compliance [30][35] Competitive Landscape - The company believes that gene editing will provide a superior long-term solution compared to ongoing treatments like siRNA, which require continuous administration [34][36] - The potential for significant cost savings and improved patient compliance with a one-time gene editing therapy versus ongoing treatments [35][36] Future Expectations - Upcoming data releases are anticipated to further validate the efficacy of ANGPTL3 and Lp targeting therapies, with a focus on biomarker-based approvals rather than traditional outcome studies [24][37] - The company is exploring strategic partnerships, particularly in the cardiovascular and autoimmune spaces, as interest in cell and gene therapies increases [52][53] Additional Insights - The company is also working on regenerative medicine for type one diabetes, with ongoing trials for both encapsulated and unencapsulated islet cells [51] - The allogeneic CAR T platform is being optimized, with promising data expected mid-year [45][48] This summary encapsulates the critical aspects of CRISPR Therapeutics' current status, product pipeline, market positioning, and future outlook based on the conference call.