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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 two poster presentations regarding nemvaleukin alfa at the ESMO Virtual Congress from Sept. 16-21, 2021. The presentations focus on the ARTISTRY-6 global phase 2 trial evaluating nemvaleukin monotherapy for melanoma patients previously treated with anti-PD-(L)1 therapy, along with preclinical data on its efficacy in treating small cell lung cancer. The data aims to support registration in mucosal melanoma. Alkermes is exploring nemvaleukin's potential as a novel therapy for various tumor types.
Alkermes plc (Nasdaq: ALKS) will open applications for its 4th Annual Alkermes Pathways Research Awards program on Sept. 13, 2021. This competitive grant initiative aims to support early-career researchers advancing understanding of diseases such as schizophrenia, bipolar disorder, alcohol use disorder, and opioid use disorder. Grants of up to $100,000 will be available, with the application window closing on Nov. 12, 2021. Since its inception in 2018, the program has funded 16 research projects in the U.S.
Dublin-based Alkermes plc (Nasdaq: ALKS) announced participation in the Citi 16th Annual BioPharma Virtual Conference on September 9, 2021, at 8:50 a.m. ET. The management will engage in a fireside chat during the event, which will be accessible via the Investors tab on their website. The presentation will be available for 14 days post-event. Alkermes focuses on developing innovative medicines for neuroscience and oncology and has a portfolio that includes products for addiction, schizophrenia, and bipolar disorder.
Alkermes (Nasdaq: ALKS) announced that the FDA granted Fast Track designation to its investigational immunotherapy nemvaleukin alfa for mucosal melanoma treatment. This follows the earlier orphan drug designation for the same condition. Enrollment has begun in the ARTISTRY-6 Phase 2 trial, assessing nemvaleukin's anti-tumor activity in patients previously treated with anti-PD-(L)1 therapies. Fast Track designation allows for expedited development and review processes, highlighting the unmet medical needs in this severe melanoma type.
Alkermes plc (NASDAQ: ALKS) reported Q2 2021 revenues of $303.7 million, up from $247.5 million year-over-year. Key products VIVITROL and ARISTADA saw 23% growth, with net sales of $88.4 million and $72.4 million respectively. Net income was $2.4 million, a turnaround from a $29.4 million loss last year. The company raised its 2021 financial expectations to total revenues of $1,145 – $1,185 million, citing solid commercial performance and the FDA approval of LYBALVI for schizophrenia and bipolar disorder. The cash position improved to $669.4 million.
Alkermes plc (Nasdaq: ALKS) has announced the 2021 recipients of its Alkermes Inspiration Grants program, awarding funds to 11 nonprofit organizations addressing the needs of individuals living with addiction, serious mental illness, or cancer. The grants prioritize programs aiding historically under-resourced communities, including BIPOC and LGBTQ+ populations. Over 250 applications were submitted, highlighting Alkermes' commitment to supporting health equity. Since 2016, the program has disbursed over $4 million to initiatives that enhance patient care beyond traditional treatment.
Alkermes plc (Nasdaq: ALKS) will hold a conference call on July 28, 2021, at 8:00 a.m. ET to discuss its second quarter 2021 financial results. The call will provide updates on the company's performance and developments in its product pipeline focused on neuroscience and oncology. Interested parties can access the call via phone or webcast through Alkermes' website. Replay options will be available shortly after the event.
On June 30, 2021, Alkermes plc (Nasdaq: ALKS) presented new research on healthcare resource use (HRU) among veterans with alcohol dependence at the RSA/ISBRA Conference. The study analyzed 3,665 patients from the Veterans Health Administration database, revealing that VIVITROL treatment led to decreased inpatient admissions (from 61.5% to 37.8%) and increased outpatient care during the year after treatment initiation. Alkermes emphasized the importance of further research to understand VIVITROL's impact on healthcare engagement and outcomes in this population.
Alkermes has named former MLB player CC Sabathia as the spokesperson for its My Relationship with Alcohol campaign. This initiative aims to raise awareness about alcohol dependence and encourages individuals to seek help from healthcare providers. Sabathia, who has publicly shared his recovery journey, emphasizes the importance of addressing alcohol dependence as a chronic disease rather than a personal failing. The campaign is timed with societal shifts post-pandemic, highlighting the need for support and education on mental health related to alcohol consumption.