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ESPR Settles Nexletol/Nexlizet Patent Litigation With RDY, Stock Up
ZACKS· 2025-10-06 14:56
Key Takeaways Esperion reached a settlement with Dr. Reddy's over patents for Nexletol and Nexlizet.RDY agreed not to launch U.S. generics of the drugs before April 19, 2040, under the deal.The settlement resolves remaining disputes with RDY tied to Esperion's key bempedoic acid patent.Esperion Therapeutics (ESPR) announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories (RDY) related to patents for the marketed drugs, Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ...
Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy’s Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040
Globenewswire· 2025-10-03 12:00
ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and N ...
Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy's Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040
Globenewswire· 2025-10-03 12:00
ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and N ...
Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of Hypercholesterolemia
Globenewswire· 2025-09-19 12:00
Core Insights - Esperion has received regulatory approval for NEXLETOL® (bempedoic acid) in Japan, marking a significant milestone in its international growth strategy [1][2] - The approval allows Esperion to expand its global footprint in the cardiovascular prevention market, which is crucial for patients needing non-statin LDL-C lowering therapies [2] - The partnership with Otsuka Pharmaceutical is expected to unlock substantial value in Japan, with Esperion set to receive milestone payments and tiered royalties based on sales performance [2] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medications for patients at risk of cardiovascular disease [3] - The company’s products are supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients, highlighting its commitment to addressing unmet medical needs [3] - Esperion is advancing its pipeline with a focus on developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design [3][4] Market Position - The approval of NEXLETOL in Japan, alongside existing approvals in the U.S. and Europe, positions Esperion as a key player in the global cardiovascular market [2] - The company aims to drive long-term growth and shareholder value through continued innovation and market expansion [2]
Esperion: A Mixture Of Opportunity And Risk: Why I Would Hold For Now
Seeking Alpha· 2025-09-09 19:10
Core Insights - Esperion Therapeutics, Inc. (NASDAQ: ESPR) has experienced significant stock price appreciation, exceeding 30% this month after reaching a 52-week low of below $1 in April [1] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing therapies for patients with elevated low-density lipoprotein cholesterol (LDL-C) [1] Market Performance - The stock's recovery indicates a positive market sentiment and potential investor confidence in the company's future prospects [1]
Esperion Therapeutics (NasdaqGM:ESPR) FY Conference Transcript
2025-09-08 19:02
Summary of UR Energy Conference Call Company Overview - UR Energy is a US-based producer, developer, and explorer for uranium, primarily operating in Wyoming, and is listed on the New York and Toronto stock exchanges. It is one of only three companies currently producing and selling uranium in the United States [2][3]. Key Properties - **Lost Creek**: - Produced approximately 3,000,000 pounds of uranium since 2013. - Contains over 12,000,000 pounds in measured and indicated resources and over 6,000,000 pounds in inferred resources. - Has a remaining mine life of thirteen years. - Year-to-date production for 2025 is over 200,000 pounds, with a full production capacity of 1,200,000 pounds per year. - Operating costs for the second quarter were $42.83 per pound, with an average contract price of $61.56 per pound for 2025 [3][4][8]. - **Shirley Basin**: - Contains 8,800,000 pounds of uranium in the measured and indicated category. - Full production capacity is 1,000,000 pounds per year, with construction well advanced and production startup targeted for early 2026 [4][5]. Market Dynamics - The US nuclear supply accounts for 20% of electricity consumption, with 440 nuclear reactors currently in operation and another 66 under construction, indicating growing demand for uranium [6][7]. - Geopolitical risks are significant, as Russia supplies 20% of enriched uranium and Kazakhstan produces approximately 46% of global supply [7]. - The US government is supporting the nuclear industry, with $2.7 billion allocated to enhance domestic fuel supply through the Nuclear Fuel Security Act [8]. Financial Insights - UR Energy closed July with $49.1 million in financing and has long-term contracts covering about 45% of production through 2023 [18][19]. - Current contracts are shifting from fixed pricing to a hybrid model that includes both fixed and market-related pricing, with fixed prices currently in the low seventies [30][32]. - The company aims to lock in contracts to ensure cash-positive sales, with a focus on increasing earnings per share through reliable production and managing operating costs [33][49]. Strategic Outlook - UR Energy is focused on ISR (In Situ Recovery) mining, with three properties: one in production (Lost Creek), one in construction (Shirley Basin), and one in exploration (Lost Soldier) [38]. - The company is optimistic about the future of uranium production in the US, anticipating a potential premium for US-produced uranium due to geopolitical factors [46][47]. - Analysts are generally positive about UR Energy's strategy, although there are concerns about accurately reflecting the current market environment in forecasts [37]. Additional Considerations - The company emphasizes its environmentally friendly practices, recycling 99.3% of water used in the extraction process [18]. - The transition to a hybrid pricing model reflects a broader trend in the uranium market, where contracts are becoming more flexible to adapt to market conditions [30][32].
Esperion Therapeutics, Inc. (ESPR) Presents At Cantor Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-08 02:17
Company Overview - Esperion Therapeutics is focused on commercializing life-saving medications, specifically NEXLIZET and NEXLETOL [3] - The company is also developing additional life-saving medications, with a recent R&D Day highlighting interesting compounds [3] Financial Performance - Esperion reported significant momentum in its Q2 results, showing double-digit growth across all metrics [3] Industry Engagement - The company had a successful presence at the European Society of Cardiology, which positively influenced its guidelines [3]
Top 2 Health Care Stocks That May Plunge This Month
Benzinga· 2025-09-05 14:39
Core Insights - Two stocks in the health care sector are signaling potential warnings for momentum-focused investors as of September 5, 2025 [1] Group 1: Esperion Therapeutics Inc (ESPR) - Esperion Therapeutics reported better-than-expected second-quarter financial results, highlighting a 15% sequential quarterly growth and 42% year-over-year growth in net U.S. product sales [7] - The company's stock surged approximately 56% over the past month, reaching a 52-week high of $3.94 [7] - The RSI value for Esperion is 85.7, indicating it is considered overbought [7] Group 2: Nuvation Bio Inc (NUVB) - Nuvation Bio reported an in-line loss for the second quarter but noted the FDA approval of IBTROZI, marking its transition into a commercial-stage company [8] - The stock gained around 44% over the past month, with a 52-week high of $3.48 [8] - The RSI value for Nuvation Bio is 81.8, also indicating it is considered overbought [8]
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-09-03 14:47
Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Focus**: Commercialization of life-saving medications, specifically Nexlizet and Nexletol, with ongoing development of new compounds [7][8][60] Key Points Industry Context - **Cardiovascular Disease**: Identified as the number one killer globally, emphasizing the need for effective lipid-lowering therapies [10][12][43] - **Statin Intolerance**: Approximately 30% of patients cannot tolerate statins, creating a significant market opportunity for alternative therapies like Nexlizet [19][36] Product Performance - **Growth Metrics**: Double-digit growth reported in all metrics for Q2, indicating strong market momentum [7] - **Combination Therapy**: Emphasis on the need for combination therapies to achieve LDL-C goals, with Nexlizet showing 38% additional efficacy when added to statins [19][28] Market Strategy - **Geographic Expansion**: Strong traction in Europe, with potential for similar success in the U.S. and Japan, where statin intolerance is prevalent [31][32] - **Guideline Influence**: Received a Class 1A recommendation in new guidelines, positioning bempedoic acid as a foundational therapy [34][35][49] Financial Outlook - **Positive Financial Trajectory**: Achieved positive operating income for the first time from ongoing operations, with expectations for full profitability by Q1 2026 [67][68] - **Cash Position**: Ample cash reserves and reduced debt profile, supporting ongoing growth initiatives [69] Future Developments - **New Indications**: Exploring treatment for primary sclerosing cholangitis (PSC), with confidence in the unique mechanism of action of their compounds [60][62] - **Triple Oral Combination**: Development of a triple oral combination therapy expected to enhance LDL-C reduction efficacy [38][39] Consumer Engagement - **Marketing Initiatives**: Upcoming consumer-directed commercials aimed at educating patients about heart health and the importance of treatment adherence [25][27] Competitive Landscape - **Market Positioning**: While competition exists, the unique efficacy and combination potential of Nexlizet provide a strong market position [45][46] Additional Insights - **Patient Education**: Importance of educating patients about their cardiovascular risk to encourage adherence to treatment [21][22] - **Regulatory Milestones**: Anticipated regulatory approvals in Japan tied to significant financial milestones, indicating a robust partnership with Otsuka [70][71] This summary encapsulates the key insights from the conference call, highlighting Esperion Therapeutics' strategic focus, market opportunities, and financial health.
Esperion’s Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Globenewswire· 2025-08-29 12:00
Core Insights - Bempedoic acid has received strong endorsement from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines as the only non-statin recommended for lowering LDL-C and reducing cardiovascular risk [1][4] - The guidelines emphasize an early and aggressive approach to combination lipid-lowering therapy, which aligns with the company's strategy to develop oral triple combination therapies in the U.S. [1][5] Company Developments - Esperion's President and CEO highlighted the significance of the guideline recognition for both European and U.S. markets, indicating that it will inform upcoming U.S. cholesterol treatment guidelines [2] - The company is strategically positioned to lead in the development of the first oral lipid-lowering triple combination pill in the U.S., which aims to provide unprecedented LDL-C lowering and improved patient adherence [5][16] Product Information - NEXLIZET and NEXLETOL are indicated for patients unable to take statin therapy, with bempedoic acid recommended for achieving LDL-C goals [6][7] - The guidelines recommend the addition of bempedoic acid to maximally tolerated doses of statins for high-risk patients to achieve LDL-C goals [6] Clinical Evidence - The clinical benefits of bempedoic acid are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, which validates its role in cardiovascular risk reduction [16]