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 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.
Alkermes plc (Nasdaq: ALKS) reported Q3 2020 revenues of $265 million, up from $255.2 million year-over-year. The GAAP net loss was nearly eliminated at $0.1 million, compared to a loss of $52.9 million last year. Non-GAAP net income rose to $41.5 million, or $0.26 per share. VIVITROL sales dipped 6% due to COVID-19 but grew 12% sequentially, while ARISTADA sales increased 16%. Alkermes raised its 2020 revenue guidance to $1.01-$1.035 billion, and net income expectations align with pre-COVID guidance. The FDA reviews for ALKS 3831 are pending, with a decision expected by Nov. 15, 2020.
Alkermes plc (Nasdaq: ALKS) will hold a conference call and webcast on October 29, 2020, at 8:00 a.m. ET to discuss its third quarter 2020 financial results and provide updates on company performance. The event will be accessible via the company's website. A replay will be available starting at 11:00 a.m. ET on the same day, lasting until November 5, 2020. Alkermes focuses on innovative medicines in neuroscience and oncology, featuring a pipeline for treatments in addiction, schizophrenia, and cancer.
On October 9, 2020, Alkermes plc (Nasdaq: ALKS) announced positive outcomes from the FDA advisory committee meetings regarding ALKS 3831, a new treatment for schizophrenia and bipolar I disorder. The committees voted 16-1 in favor of ALKS 3831's ability to mitigate weight gain associated with olanzapine and 13-3-1 regarding its safety profile. The FDA's review is ongoing, with a PDUFA date set for November 15, 2020. The NDA for ALKS 3831 is backed by data from 27 clinical studies, indicating robust support for the drug's approval.
Alkermes plc (Nasdaq: ALKS) announced a temporary halt in trading of its ordinary shares as the FDA advisory committees convene to review the company's New Drug Application for ALKS 3831, an investigational treatment for schizophrenia and bipolar I disorder. The virtual meeting is scheduled for 10:00 a.m. ET today, with a PDUFA action target date of Nov. 15, 2020. These developments highlight the potential impact of ALKS 3831 in the market, considering the significant prevalence of the targeted disorders, affecting millions in the U.S.
Alkermes plc (Nasdaq: ALKS) announced that the FDA has posted briefing documents for the Oct. 9, 2020 advisory committee meeting to review its New Drug Application (NDA) for ALKS 3831, an oral atypical antipsychotic for schizophrenia and bipolar I disorder. The meeting will be held virtually at 10:00 a.m. ET. The PDUFA target action date for this NDA is Nov. 15, 2020. ALKS 3831 combines samidorphan, a new molecule, with olanzapine in a single tablet.