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) 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.
Alkermes (Nasdaq: ALKS) announced that its investigational drug, nemvaleukin alfa, received orphan drug designation from the FDA for treating mucosal melanoma. This designation highlights the drug's potential in addressing a rare and aggressive cancer type with limited treatment options. Dr. Jessicca Rege emphasized the importance of this milestone, which comes with benefits like tax credits and market exclusivity for the company. The ARTISTRY development program will advance nemvaleukin's clinical evaluation in treating advanced solid tumors.
Alkermes plc (Nasdaq: ALKS) will host a virtual Investor Day on March 25, 2021, at 9:00 a.m. ET. Senior management will share insights on the company's research and development strategy in neuroscience and oncology and discuss clinical data related to nemvaleukin alfa (ALKS 4230). The event will also highlight earlier stage programs, including ALKS 1140, and cover the Value Enhancement Plan initiated in December 2020. Investors can pre-register for the webcast on the company’s website.
Alkermes plc (Nasdaq: ALKS) announced its participation in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on February 24, 2021, at 9:20 a.m. ET. The event will be accessible via the Investors tab on their website and will be archived for 14 days. Alkermes is a global biopharmaceutical company focused on medicine development in neuroscience and oncology, with a portfolio centered on addiction and schizophrenia treatments, and a pipeline targeting various disorders.
Alkermes plc (Nasdaq: ALKS) reported its financial results for Q4 and the full year 2020, highlighting total revenues of $280 million for Q4, down from $412.7 million YoY. The annual revenue was $1.04 billion, a decline from $1.17 billion in 2019. The company experienced a net loss of $110.9 million for 2020, narrowed from a loss of $196.6 million in the prior year. For 2021, Alkermes forecasts revenues between $1.1 billion and $1.17 billion, alongside expected net losses of $85-125 million. The company emphasizes growth from new drug launches and ongoing clinical programs.
Alkermes plc (Nasdaq: ALKS) will host a conference call on February 11, 2021 at 8:00 a.m. ET to discuss its fourth quarter and year-end 2020 financial results. Management will outline financial expectations for 2021 and provide company updates. The presentation can be accessed via the investor section on Alkermes' website. A replay of the call will be available from February 11 to February 18, 2021. Alkermes is focused on developing innovative medicines in neuroscience and oncology, with a diverse product pipeline targeting various mental health and cancer disorders.
Alkermes announced the publication of a NIDA-funded study in the New England Journal of Medicine, investigating the safety and efficacy of extended-release injectable naltrexone (XR-NTX) combined with oral bupropion for treating methamphetamine use disorder (MUD). The study involved 403 adults with moderate to severe MUD over 12 weeks, showing a significant improvement in response rates for those receiving the combination therapy versus placebo. With no FDA-approved treatments for MUD currently available, Alkermes aims to discuss these findings with the FDA for potential therapeutic options.