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.
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.
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®.