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.
Alkermes plc (Nasdaq: ALKS) is a global biopharmaceutical company focused on neuroscience, and its news flow reflects both commercial execution and clinical development in this area. Company announcements emphasize proprietary products for alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, alongside a growing pipeline targeting neurological disorders such as narcolepsy and idiopathic hypersomnia.
Recent news has highlighted alixorexton, Alkermes investigational oral, selective orexin 2 receptor agonist. The company has reported positive phase 2 data from the Vibrance-1 study in narcolepsy type 1 and the Vibrance-2 study in narcolepsy type 2, and has announced that alixorexton is being evaluated in the Vibrance-3 study in idiopathic hypersomnia. In a separate update, Alkermes disclosed that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to alixorexton for narcolepsy type 1, based on phase 1 and phase 2 data.
Investors following ALKS news will also see regular earnings releases, where the company reports quarterly revenues, net income, EBITDA and adjusted EBITDA, and provides updates to its financial expectations. These releases describe trends in proprietary product sales, including VIVITROL, ARISTADA and LYBALVI, and manufacturing and royalty revenues related to VUMERITY and certain long-acting antipsychotic products.
Another key theme in Alkermes news is corporate transactions and financing. The company has announced a transaction agreement, and later an amendment, to acquire Avadel Pharmaceuticals plc, adding LUMRYZ, an FDA-approved once-at-bedtime oxybate for narcolepsy, to its commercial portfolio if the transaction is completed. Related filings describe an amended and restated bridge term loan credit agreement designed to support financing of the proposed acquisition.
Visitors to the ALKS news page can expect updates on clinical trial milestones, regulatory designations, quarterly financial performance, investor conference participation and material corporate agreements. This mix of scientific, financial and strategic information provides context for understanding Alkermes evolving position in neuroscience and sleep medicine.
Alkermes plc (Nasdaq: ALKS) announced new data from its ARTISTRY clinical program regarding nemvaleukin alfa, an investigational immunotherapy, presented at the 2021 ASCO Annual Meeting. Key highlights include updated efficacy and safety data from the ARTISTRY-1 phase 1/2 study, showing anti-tumor activity in melanoma, renal cell carcinoma, and platinum-resistant ovarian cancer. The ARTISTRY-2 study data support a recommended phase 2 dose for subcutaneous nemvaleukin, providing early signs of anti-tumor activity. Adverse events were manageable. The company is committed to developing treatments for difficult-to-treat cancers.
Alkermes plc (Nasdaq: ALKS) will participate in a virtual fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, 2021, at 10:30 a.m. ET. The event will be available under the Investors tab on their website and archived for 14 days. Alkermes is a global biopharmaceutical company focused on developing innovative medicines for neuroscience and oncology, with a portfolio addressing addiction, schizophrenia, and bipolar I disorder.
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™.
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