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) 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.
Alkermes plc (Nasdaq: ALKS) will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:00 a.m. EST. CEO Richard Pops will lead the virtual session, which includes a question and answer segment. The presentation can be accessed under the Investors tab on Alkermes' website and will be archived for 14 days. Alkermes specializes in developing innovative medicines for neuroscience and oncology, with a focus on addiction and schizophrenia. The company is headquartered in Dublin, Ireland.
Alkermes plc (Nasdaq: ALKS) announced new executive appointments on January 6, 2021, including Blair C. Jackson as Chief Operating Officer and Iain M. Brown as Chief Financial Officer, replacing James M. Frates, who departs after 20 years. Jackson will oversee global operations, while Brown will manage the finance organization, enhancing leadership during the implementation of the Value Enhancement Plan. The company continues to focus on delivering value to stakeholders and expects these changes to strengthen its operational capabilities.
Alkermes plc (Nasdaq: ALKS) announced the FDA's receipt of its resubmitted New Drug Application (NDA) for ALKS 3831, aimed at treating adults with schizophrenia and bipolar I disorder. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. The resubmission was classified as a complete Class 2 response to the Complete Response Letter issued in November 2020. The FDA did not raise concerns about the clinical data and has not requested new clinical trials, enabling Alkermes to expedite the review process.
Alkermes plc (Nasdaq: ALKS) announced a Value Enhancement Plan aimed at boosting growth and shareholder value, which includes commitments to profitability targets and cost structure optimization. The plan highlights multi-year targets of 25% and 30% non-GAAP net income for FY 2023 and FY 2024, respectively. Alkermes will also review non-core assets for potential monetization and enhance corporate governance by adding two new independent directors. The company continues to focus on the commercial launch of ALKS 3831 and progressing its drug pipeline amidst a supportive dialogue with shareholders.
Alkermes plc (Nasdaq: ALKS) received a Complete Response Letter from the FDA regarding its NDA for ALKS 3831, a treatment for schizophrenia and bipolar I disorder. The FDA noted that certain manufacturing conditions must be resolved before approval. No clinical data concerns were raised, and Alkermes believes the issues have been addressed. The company plans to submit additional data to the FDA and work closely to resolve the outstanding items. ALKS 3831 has shown consistent efficacy and safety in clinical studies, with 27 studies forming the basis of the NDA.
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Alkermes plc (Nasdaq: ALKS) has rescheduled its third quarter financial results conference call to 10:30 a.m. ET on October 29, 2020, due to technical difficulties with the conference call provider. The call will be accessible via a webcast on Alkermes' website. Additionally, a replay will be available until November 5, 2020. Alkermes focuses on developing innovative medicines in neuroscience and oncology, with products targeting addiction and schizophrenia, alongside a promising pipeline for various disorders.
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