Cardiovascular Disease

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NewAmsterdam Pharma Announces Late-Breaking Data from BROADWAY and TANDEM Pivotal Studies Published in Leading Medical Journals and Presented at the European Atherosclerosis Society (EAS) Congress 2025
Globenewswire· 2025-05-07 11:15
Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]
Amarin Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-07 11:00
-- First Quarter 2025 Performance Reflects Contribution from Multiple Revenue Streams Across Geographies, Efforts to Support Strong Balance Sheet and Continued Strategic Execution to Maximize Global Value of VASCEPA/VAZKEPA -- -- Nasdaq Listing Compliance Regained Following Completed 1-For-20 ADS Ratio Change -- -- Company to Host Conference Call Today at 8:00 a.m. EDT -- Total net revenue for the three months ended March 31, 2025 was $42.0 million, compared to $56.5 million in the corresponding period of 2 ...
Esperion(ESPR) - 2025 Q1 - Earnings Call Presentation
2025-05-06 11:18
Q1 2025 Earnings Presentation May 6, 2025 © 2025 Esperion Therapeutics, Inc. All rights reserved. Forward-looking Statements & Disclosures This investor 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, plans for potential future product candida ...
Amarin Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-04-29 20:15
-- Nasdaq Compliance Follows ADS Ratio Change to Secure Company’s Public Listing -- -- Amarin Remains Focused on Maximizing the Global Value of VASCEPA/VAZKEPA – DUBLIN and BRIDGEWATER, N.J., April 29, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. On April 29, 2025, the Company received confirmation ...
Verve Therapeutics (VERV) Conference Transcript
2025-02-05 15:00
Verve Therapeutics (VERV) Conference February 05, 2025 09:00 AM ET Company Participants Sekar Kathiresan - Co-Founder, CEO & Director Operator Well, good morning, everybody. Thanks for joining us here at Guggenheim's SMIDCAP biotech conference. We sort of target companies below the kind of $12,000,000,000 threshold for this conference because these tend to be the companies that actually have the highest returns, in biotech overall. So it's a great opportunity to be joined here this morning by Verve Therapeu ...
Esperion Therapeutics (ESPR) Update / Briefing Transcript
2025-01-22 18:30
Esperion Therapeutics (ESPR) Update / Briefing January 22, 2025 12:30 PM ET Speaker0 Good afternoon, and welcome to Experian's virtual KOL event. A question and answer session will follow the formal presentation. As a reminder, this call is being recorded, and a replay will be made available on Experian's website following the conclusion of the event. And now I'd like to turn the call over to Sheldon Koenig, Chief Executive Officer of Esperion. Speaker1 Thank you very much, and good morning, everyone. Welco ...