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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) is set to present positive data from the ARTISTRY-1 clinical trial, showcasing the anti-tumor activity of nemvaleukin as both a monotherapy and in combination with pembrolizumab (KEYTRUDA®). This phase 1/2 study revealed significant responses in difficult-to-treat tumors, including melanoma and renal cell carcinoma. The company will host an investor webcast on June 6, 2022, to discuss these findings further, emphasizing the potential for nemvaleukin in improving cancer therapy outcomes.
Sarissa Capital Management expresses serious concerns over the corporate governance of Alkermes (NASDAQ: ALKS), claiming the board is heavily influenced by CEO Richard Pops, who they allege has caused significant shareholder value destruction over 30 years. In a statement, Sarissa criticized the abrupt ending of discussions about director nominations and highlighted the board's neglect of shareholder interests. Despite Alkermes achieving over $1 billion in revenue from 2017-2021, the company consistently operated at a net loss while underperforming the IBB index by 130%.
Alkermes plc (Nasdaq: ALKS) announced the appointment of Nancy J. Wysenski as the new Lead Independent Director and the retirement of long-serving directors David W. Anstice AO and Wendy L. Dixon, Ph.D. The company also filed a preliminary proxy statement for its upcoming Annual General Meeting. Additionally, Christopher I. Wright, M.D., Ph.D., was appointed to the Board, bringing significant experience in neuroscience and drug development. These moves are part of Alkermes' ongoing commitment to corporate governance and board refreshment.
Alkermes plc (Nasdaq: ALKS) has announced that four abstracts related to its investigational immunotherapy, nemvaleukin alfa, have been accepted for presentation at the 2022 ASCO Annual Meeting from June 3-7, 2022. A key highlight will be an oral presentation of the final dataset from the ARTISTRY-1 clinical trial, showcasing the safety and effectiveness of nemvaleukin combined with pembrolizumab. Additionally, three trial-in-progress posters will provide updates from ongoing ARTISTRY trials, further exploring nemvaleukin's potential in treating advanced solid tumors.
Alkermes reported Q1 2022 revenues of $278.5 million, up from $251.4 million YoY, driven by strong sales of LYBALVI®, ARISTADA®, and VIVITROL®. Net sales of proprietary products rose to $171.3 million, with LYBALVI generating $13.9 million. However, a GAAP loss per share of $0.22 was noted, compared to $0.14 the previous year. Total operating expenses increased to $305.1 million. Alkermes reiterated its financial expectations for the year, emphasizing growth in its proprietary portfolio amidst a challenging landscape.
Alkermes plc (Nasdaq: ALKS) will host a conference call on April 27, 2022, at 8:00 a.m. ET to discuss its first quarter financial results. The call will provide updates on the company's performance and future outlook. Investors can access the live webcast and slides through the Alkermes website. For participation, U.S. callers can dial +1 877 407 2988, while international callers can use +1 201 389 0923. A replay of the event will be available shortly after its conclusion.
Alkermes plc (Nasdaq: ALKS) has initiated binding arbitration with Janssen Pharmaceutica regarding two license agreements associated with NanoCrystal® Technology. Janssen partially terminated these agreements in February 2022 and has ceased paying royalties on related product sales in the U.S. Alkermes disputes Janssen's stance and asserts that royalties are still owed. Efforts for a mutual settlement have failed, leading to arbitration under CPR rules. This arbitration could impact Alkermes' financial position depending on the outcome.
On April 7, 2022, Alkermes plc (Nasdaq: ALKS) presented new data from the ENLIGHTEN-Early study of LYBALVI® (olanzapine and samidorphan) at the Schizophrenia International Research Society Congress in Florence, Italy. This Phase 3b study focused on body weight effects in young adults with schizophrenia and related disorders. Additionally, Alkermes shared findings on cognitive impairment assessments for patients switching to ARISTADA®. The presentations highlight Alkermes' commitment to addressing serious mental illnesses.
Alkermes plc (Nasdaq: ALKS) announced that CEO Richard Pops will participate in a fireside chat at the Stifel 2022 CNS Days on March 29, 2022, at 8:30 a.m. ET. The event will be accessible via a live webcast on the company's website, with an archive available for 14 days afterward. Alkermes is a global biopharmaceutical company based in Dublin, focusing on innovative treatments in neuroscience and oncology, including products for alcohol dependence, opioid dependence, schizophrenia, and bipolar disorder.
Alkermes plc (Nasdaq: ALKS) will present data on nemvaleukin alfa, an investigational immunotherapy, at the Society of Gynecologic Oncology 2022 Annual Meeting from March 18-21, 2022. The focus will be on outcomes from the ARTISTRY-1 study in platinum-resistant ovarian cancer patients, with a plenary oral presentation scheduled for March 19. Additionally, a poster on the ongoing ARTISTRY-7 study will be presented, comparing nemvaleukin plus pembrolizumab against chemotherapy. These studies aim to evaluate the safety and effectiveness of nemvaleukin in cancer treatment.
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