Alkermes plc develops and commercializes neuroscience medicines, with proprietary commercial products used in alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Company news commonly covers quarterly financial results, full-year expectations, commercial execution and presentations at healthcare and CNS investor conferences.
Clinical and medical updates focus on the company’s sleep-wake and psychiatric portfolio, including LYBALVI in schizophrenia and bipolar I disorder and alixorexton, an investigational oral selective orexin 2 receptor agonist in development for narcolepsy and idiopathic hypersomnia. Other updates include peer-reviewed data publications, research award programs and corporate developments tied to Alkermes’ biopharmaceutical operations.
Alkermes plc (Nasdaq: ALKS) announced its participation in the fourth annual Evercore ISI HealthCONx Conference on December 2, 2021, at 10:30 a.m. ET. The event will be accessible under the Investors section of Alkermes' website and archived for 14 days. Alkermes is a global biopharmaceutical company focused on developing innovative medicines in neuroscience and oncology, with a pipeline targeting neurodegenerative disorders and cancer.
Alkermes plc (Nasdaq: ALKS) has appointed Cato T. Laurencin, M.D., Ph.D., as a new independent director to its Board. Dr. Laurencin is a distinguished academic and pioneer in regenerative engineering with a strong focus on public health and social justice. His appointment, welcomed by CEO Richard Pops, is expected to enhance the company’s innovation and shareholder value creation strategies. Alex Denner of Sarissa Capital views this as a positive outcome for shareholders, anticipating a fresh perspective and improved operational excellence.
Alkermes plc (Nasdaq: ALKS) has initiated a Phase 1 study for ALKS 1140, an investigational HDAC inhibitor aimed at treating neurodegenerative disorders. The study's first subject has been dosed, targeting safety and tolerability in healthy adults. ALKS 1140 is designed to enhance synaptic function, addressing significant unmet medical needs. The trial will involve up to 80 volunteers in Australia and assess pharmacokinetics and pharmacodynamics, marking a crucial step in Alkermes’ clinical program.
Alkermes plc (Nasdaq: ALKS) will participate in a fireside chat at the Stifel Virtual Healthcare Conference on November 16, 2021, at 9:20 a.m. ET. Investors can access the presentation via the Investors tab on the company's website. Alkermes focuses on developing innovative medicines in neuroscience and oncology, with a range of products targeting addiction, schizophrenia, and bipolar I disorder. The company has R&D facilities in Massachusetts and manufacturing sites in Ireland and Ohio.
On Nov. 8, 2021, Alkermes plc (Nasdaq: ALKS) announced it received notices of partial termination from Janssen Pharmaceutica regarding two license agreements concerning the use of Alkermes' NanoCrystal® technology. This impacts royalties from products like INVEGA SUSTENNA® and INVEGA TRINZA®. While Janssen claims it does not use this technology, Alkermes disputes this and will explore enforcement options. CFO Iain Brown indicated that while cash flow could be adversely impacted in the coming years, the company's long-term outlook remains unchanged, with expected growth from products like LYBALVI®, ARISTADA®, and VUMERITY®.
Alkermes plc (Nasdaq: ALKS) announced it will present a poster on nemvaleukin alfa at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting from Nov. 10-14, 2021. The poster will feature data from the ION-01 study, a phase 2 trial assessing the combination of intravenous nemvaleukin with pembrolizumab in patients with head and neck squamous cell carcinoma. The presentation by Brian Gastman, M.D., is scheduled for Nov. 13, 2021, with the poster available on the SITC platform from Nov. 12, 2021.
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.