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Alkermes Inc. plc (NASDAQ: ALKS) is a global biopharmaceutical company dedicated to developing innovative medicines for treating central nervous system (CNS) diseases. Headquartered in Dublin, Ireland, Alkermes has a significant presence in the United States with a research and development center in Waltham, Massachusetts, and a manufacturing facility in Wilmington, Ohio. The company’s mission is to leverage its proprietary technologies to create and commercialize pharmaceutical products that address unmet medical needs in conditions such as schizophrenia, depression, addiction, and multiple sclerosis.
Alkermes’ diversified product portfolio includes notable medications like LYBALVI®, ARISTADA®, and VIVITROL®. These products are pivotal in the treatment of mental health disorders and substance abuse, demonstrating the company's commitment to enhancing patient outcomes. LYBALVI®, a combination of olanzapine and samidorphan, is used for treating schizophrenia and bipolar I disorder. ARISTADA® is an extended-release injectable suspension for schizophrenia, and VIVITROL® is used for alcohol and opioid dependence.
The company's robust clinical pipeline features breakthrough candidates such as ALKS 2680, an investigational orexin 2 receptor agonist targeting narcolepsy. Recent study results announced in early 2024 have shown promising improvements in wakefulness for patients with narcolepsy type 2 and idiopathic hypersomnia, validating the potential of ALKS 2680 to address critical gaps in treatment.
Alkermes has also engaged in significant corporate developments, including the sale of its Athlone, Ireland facility to Novo Nordisk, aimed at increasing operational efficiency. Financially, the company reported total revenues of $1.66 billion for 2023, with a net income of $356 million, emphasizing strong growth and profitability. The company's strategic focus on neuroscience and operational efficiency is expected to drive sustained profitability and innovation in treating CNS disorders.
For more detailed information about Alkermes’ products, clinical trials, and corporate strategies, you can visit their official website at www.alkermes.com.
Alkermes plc (Nasdaq: ALKS) announced FDA approval for LYBALVI™ (olanzapine and samidorphan) to treat adults with schizophrenia and bipolar I disorder. LYBALVI is a once-daily oral atypical antipsychotic that combines olanzapine and the new chemical entity samidorphan, showing efficacy with less associated weight gain compared to olanzapine. The approval follows the ENLIGHTEN clinical development program, which included 27 studies. Alkermes plans to commercialize LYBALVI in Q4 2021, enhancing its existing antipsychotic market presence alongside ARISTADA®.
Alkermes plc (Nasdaq: ALKS) will host a webcast on June 4, 2021, at 4:00 p.m. ET to discuss data from its ARTISTRY-1 and ARTISTRY-2 clinical trials on the cancer immunotherapy candidate nemvaleukin alfa. The session features expert oncologists, including Valentina Boni and Omid Hamid, who will present findings related to advanced solid tumors. Participants can access the live audio webcast and slides via the Alkermes website. Details on poster presentations at the ASCO Annual Meeting will also be shared, highlighting innovative cancer treatment approaches.
Alkermes plc (Nasdaq: ALKS) appointed Emily Peterson Alva as an independent director to its Board of Directors. Alva, a seasoned public company board member and former Lazard M&A Partner, brings extensive experience in strategic and financial matters, particularly in healthcare and pharmaceuticals. Her addition marks the fifth independent director appointment in two years, reinforcing Alkermes' commitment to board diversity and strong governance. CEO Richard Pops expressed confidence in her insights to enhance value creation for shareholders and drive impactful patient solutions.
Alkermes plc (Nasdaq: ALKS) announced the opening of applications for its Alkermes Inspiration Grants program on May 20, 2021. This initiative, now in its fifth year, offers up to $500,000 in grants to nonprofit organizations addressing the needs of individuals affected by addiction, serious mental illness, or cancer. The program prioritizes projects helping historically under-resourced communities. Applications will be accepted until June 17, 2021. Alkermes aims to support programs with a broad reach and sustained impact in healthcare.
Alkermes plc (Nasdaq: ALKS) will participate in a virtual fireside chat at the BofA Securities 2021 Healthcare Conference on May 12, 2021, at 2:45 p.m. ET. The presentation can be accessed through the Investors tab on their website and will be archived for 14 days. Alkermes is a biopharmaceutical company focused on developing medicines for neurological and oncological diseases, with a portfolio targeting addiction and schizophrenia. The company operates from Dublin, Ireland, and has facilities in Massachusetts, Ireland, and Ohio.
Alkermes plc (Nasdaq: ALKS) announced a new agreement with Sarissa Capital Management, granting Sarissa the right to designate a director to Alkermes' Board of Directors. This comes after two years of board refreshment efforts, which have added four independent directors. CEO Richard Pops emphasized the importance of shareholder input in identifying new board members to enhance strategic priorities and create shareholder value. Sarissa Capital's Alex Denner expressed confidence in Alkermes' assets and plans for improved capital allocation and operational excellence.
Alkermes plc (Nasdaq: ALKS) announced the acceptance of two abstracts for the upcoming 2021 ASCO Annual Meeting from June 4-8, 2021, showcasing their investigational therapy, nemvaleukin alfa. The data will detail its efficacy and tolerability from the ARTISTRY-1 and ARTISTRY-2 clinical trials. The first abstract discusses nemvaleukin monotherapy and its combination with KEYTRUDA in advanced solid tumors, while the second focuses on selecting the recommended phase 2 dose for subcutaneous administration. These presentations represent critical steps in the development of new cancer therapies.
Alkermes plc (Nasdaq: ALKS) reported Q1 2021 revenues of $251.4 million, up from $246.2 million year-over-year. Proprietary product sales totaled $130.0 million, with VIVITROL® declining by 5% to $74.5 million and ARISTADA® increasing 9% to $55.4 million. The net GAAP loss was $22.4 million ($0.14 per share), an improvement from last year's loss of $38.7 million. Alkermes reiterated its 2021 financial expectations and highlighted advancements in its drug pipeline, including the anticipated launch of LYBALVI™.
Alkermes has launched Myrelationshipwithalcohol.com, a website aimed at educating the public about alcohol dependence. This chronic disease affects millions, yet awareness of treatment options remains low. The site features educational resources, an interactive questionnaire from the NIH, and personal recovery stories to destigmatize the condition. Alkermes aims to empower individuals and caregivers to seek professional help. As a key player in this space, the company is focused on enhancing understanding and accessibility of treatment for alcohol dependence.
Alkermes plc (Nasdaq: ALKS) has initiated the ARTISTRY-6 phase 2 trial to assess the efficacy and safety of nemvaleukin alfa, its lead immuno-oncology candidate, in patients with melanoma previously treated with anti-PD-(L)1 therapy. The trial focuses on the effects of both intravenous and subcutaneous nemvaleukin in advanced mucosal and cutaneous melanoma, respectively. With approximately 110 patients to be enrolled, the study aims to evaluate primary endpoints related to overall response rates as well as secondary endpoints such as safety, duration of response, and quality of life.
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