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 its participation in several scientific conferences to present research from its psychiatry and addiction portfolios this fall. The events include Psych Congress (Oct. 29-Nov. 1), ISAD Conference (Nov. 3-4), and NEI Congress (Nov. 4-7). Key presentations will cover topics such as the impact of COVID-19 on clinic operations, opioid prescription patterns among patients, and a benefit-risk assessment of olanzapine combined with samidorphan for treating schizophrenia and bipolar I disorder. Alkermes continues its commitment to advancing care for patients with these serious conditions.
Alkermes plc (Nasdaq: ALKS) reported third-quarter 2021 revenues of $294.1 million, up from $265.0 million the previous year, with net sales of proprietary products reaching $157.7 million. The launch of LYBALVI expanded their psychiatry franchise. However, total operating expenses rose to $313.8 million, resulting in a GAAP net loss of $29.0 million. Despite the loss, non-GAAP net income was $23.6 million. Alkermes maintains its 2021 financial guidance, contingent on improving patient access and treatment normalization.
Alkermes plc (Nasdaq: ALKS) has launched ARTISTRY-7, a global phase 3 trial for the intravenous administration of nemvaleukin alfa combined with pembrolizumab in treating platinum-resistant ovarian cancer. This investigational immunotherapy aims to fulfill a significant unmet medical need. The trial will enroll approximately 376 patients, focusing on progression-free survival as the primary endpoint. The U.S. FDA has granted Fast Track designation to this combination therapy, underscoring its potential. Alkermes looks to build on previous positive responses observed in earlier studies.
Alkermes (Nasdaq: ALKS) announced the FDA has granted Fast Track designation for nemvaleukin alfa, an investigational immunotherapy, in combination with pembrolizumab for platinum-resistant ovarian cancer. This designation aims to expedite development and review processes for therapies addressing serious medical needs. The announcement includes plans to initiate the ARTISTRY-7 phase 3 trial for this treatment, which has potential significance for patients lacking approved options. Fast Track status allows for frequent communication with the FDA and the possibility of rolling reviews.
Alkermes plc (Nasdaq: ALKS) will host a conference call on October 27, 2021, at 8:00 a.m. ET to discuss its third-quarter 2021 financial results. The event will also include an update on the company's activities. Investors can access the webcast via Alkermes' website, and a replay will be available shortly after the call. Alkermes is a global biopharmaceutical company focused on innovative medicines addressing neuroscience and oncology, with products for addiction, schizophrenia, and bipolar disorder.
On October 18, 2021, Alkermes plc (Nasdaq: ALKS) announced the commercial availability of LYBALVI® (olanzapine and samidorphan) in the U.S. for treating adults with schizophrenia and bipolar I disorder. LYBALVI is a once-daily oral atypical antipsychotic that combines olanzapine with samidorphan. The FDA approved it based on data from 27 clinical studies. Alkermes aims to engage healthcare providers to enhance patient access and awareness of this new treatment option, thus expanding its psychiatry franchise.
Alkermes plc (Nasdaq: ALKS) will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on September 29, 2021, at 8:40 a.m. ET. Investors can access the presentation via the Investors tab on www.alkermes.com, where it will be archived for 14 days. Alkermes is a global biopharmaceutical company focused on neuroscience and oncology, with products related to addiction and various mental health disorders.
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Alkermes plc (Nasdaq: ALKS) announced two poster presentations regarding nemvaleukin alfa at the ESMO Virtual Congress from Sept. 16-21, 2021. The presentations focus on the ARTISTRY-6 global phase 2 trial evaluating nemvaleukin monotherapy for melanoma patients previously treated with anti-PD-(L)1 therapy, along with preclinical data on its efficacy in treating small cell lung cancer. The data aims to support registration in mucosal melanoma. Alkermes is exploring nemvaleukin's potential as a novel therapy for various tumor types.
Alkermes plc (Nasdaq: ALKS) will open applications for its 4th Annual Alkermes Pathways Research Awards program on Sept. 13, 2021. This competitive grant initiative aims to support early-career researchers advancing understanding of diseases such as schizophrenia, bipolar disorder, alcohol use disorder, and opioid use disorder. Grants of up to $100,000 will be available, with the application window closing on Nov. 12, 2021. Since its inception in 2018, the program has funded 16 research projects in the U.S.