Welcome to our dedicated page for Alkermes Plc news (Ticker: ALKS), a resource for investors and traders seeking the latest updates and insights on Alkermes Plc stock.
About Alkermes Plc
Alkermes Plc (Nasdaq: ALKS) is a global biopharmaceutical company dedicated to developing innovative medicines to address unmet medical needs in the field of neuroscience. Headquartered in Dublin, Ireland, with key research and manufacturing facilities in Waltham, Massachusetts; Athlone, Ireland; and Wilmington, Ohio, Alkermes operates as a fully integrated organization combining cutting-edge research, clinical development, and commercial expertise. The company’s mission is to improve the lives of patients suffering from complex and chronic diseases affecting the central nervous system (CNS).
Core Business Areas
Alkermes specializes in the development and commercialization of pharmaceutical products targeting CNS disorders, including schizophrenia, bipolar I disorder, alcohol and opioid dependence, and hypersomnolence disorders such as narcolepsy and idiopathic hypersomnia. Its diversified product portfolio includes proprietary medications such as:
- LYBALVI®: A once-daily oral atypical antipsychotic for schizophrenia and bipolar I disorder.
- ARISTADA®: An extended-release injectable treatment for schizophrenia.
- VIVITROL®: A monthly injectable treatment for alcohol and opioid dependence.
In addition to its commercial products, Alkermes is advancing a robust pipeline of clinical and preclinical candidates, with a particular focus on novel orexin 2 receptor agonists like ALKS 2680, designed to address excessive daytime sleepiness and other symptoms of hypersomnolence disorders.
Innovative Pipeline and Strategic Focus
Alkermes is at the forefront of neuroscience innovation, leveraging proprietary technologies to develop treatments that address significant unmet medical needs. Its investigational candidate, ALKS 2680, exemplifies this commitment by targeting narcolepsy and idiopathic hypersomnia through orexin-based mechanisms. The company is also exploring additional therapeutic areas beyond hypersomnolence disorders, with plans to expand its orexin portfolio into broader CNS applications.
In recent years, Alkermes has undergone a strategic transformation, divesting its oncology business to focus exclusively on neuroscience. This pivot has enabled the company to streamline operations, enhance profitability, and reinvest in high-potential R&D programs.
Global Operations and Market Position
With a strong global presence, Alkermes combines state-of-the-art facilities and a highly skilled workforce to drive innovation and operational excellence. The company’s manufacturing capabilities support both proprietary and partnered products, ensuring scalability and quality control. Its strategic focus on CNS disorders positions Alkermes as a significant player in a rapidly evolving market, where the demand for effective treatments continues to grow.
Commitment to Patients and Research
Alkermes is deeply committed to advancing patient care through rigorous clinical research and collaboration with the medical community. Initiatives like the Alkermes Pathways Research Awards® program underscore its dedication to fostering innovation and supporting early-career investigators in neuroscience. By prioritizing patient outcomes and scientific excellence, Alkermes aims to transform the treatment landscape for complex CNS disorders.
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.
Alkermes plc (Nasdaq: ALKS) announced a conference call and webcast to discuss its first quarter 2021 financial results on April 28, 2021, at 8:00 a.m. ET. The call will provide insights into the company's performance and updates on its operations. Interested parties can access the webcast and slides on Alkermes' website, and a replay will be available until May 5, 2021. Alkermes specializes in developing innovative medicines in neuroscience and oncology, with a focus on conditions such as addiction and schizophrenia.
Alkermes plc (Nasdaq: ALKS) presented new research from its psychiatry portfolio at the 2021 Congress of the Schizophrenia International Research Society, held virtually from April 17-21. Key findings included subgroup analyses from the phase 3 ENLIGHTEN-2 study of LYBALVI, highlighting its effect on weight gain in at-risk patients and cardiometabolic risk factors. Additionally, results from the ALPINE study suggested handwriting kinematics as a potential biomarker for treatment response in schizophrenia. Alkermes aims to advance mental health treatment options through ongoing research.
On April 7, 2021, Alkermes plc (Nasdaq: ALKS) announced a clinical trial collaboration with MSD to conduct a phase 3 study evaluating its investigational immunotherapy nemvaleukin alfa in combination with KEYTRUDA for platinum-resistant ovarian cancer. Alkermes will lead the study, expected to start in late 2021. The collaboration aims to address a significant treatment gap, as current options for these patients are limited. Early studies indicate promising antitumor activity of the combination, suggesting potential for improved outcomes in this challenging cancer type.
Alkermes plc (Nasdaq: ALKS) will participate in a virtual fireside chat at Stifel's 3rd Annual CNS Day on April 1, 2021, at 8:30 a.m. ET. The event will be accessible on the company's website and archived for 14 days. Alkermes is a biopharmaceutical company developing medicines for neuroscience and oncology, with a portfolio focused on addiction and schizophrenia. Their pipeline includes candidates for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer.
On March 25, 2021, Alkermes plc (Nasdaq: ALKS) hosted a virtual Investor Day to discuss its research and development strategy, including updates on the nemvaleukin alfa clinical program and new preclinical initiatives in neuroscience and immuno-oncology.
CEO Richard Pops highlighted the company's reimagined R&D approach, aiming for innovative medicines that address unmet patient needs. The event included presentations on innovative molecular design and ongoing clinical research, promoting the company's commitment to scientific excellence and shareholder value creation.
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