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.
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.
Dublin-based Alkermes plc (Nasdaq: ALKS) announced participation in the Citi 16th Annual BioPharma Virtual Conference on September 9, 2021, at 8:50 a.m. ET. The management will engage in a fireside chat during the event, which will be accessible via the Investors tab on their website. The presentation will be available for 14 days post-event. Alkermes focuses on developing innovative medicines for neuroscience and oncology and has a portfolio that includes products for addiction, schizophrenia, and bipolar disorder.
Alkermes (Nasdaq: ALKS) announced that the FDA granted Fast Track designation to its investigational immunotherapy nemvaleukin alfa for mucosal melanoma treatment. This follows the earlier orphan drug designation for the same condition. Enrollment has begun in the ARTISTRY-6 Phase 2 trial, assessing nemvaleukin's anti-tumor activity in patients previously treated with anti-PD-(L)1 therapies. Fast Track designation allows for expedited development and review processes, highlighting the unmet medical needs in this severe melanoma type.
Alkermes plc (NASDAQ: ALKS) reported Q2 2021 revenues of $303.7 million, up from $247.5 million year-over-year. Key products VIVITROL and ARISTADA saw 23% growth, with net sales of $88.4 million and $72.4 million respectively. Net income was $2.4 million, a turnaround from a $29.4 million loss last year. The company raised its 2021 financial expectations to total revenues of $1,145 – $1,185 million, citing solid commercial performance and the FDA approval of LYBALVI for schizophrenia and bipolar disorder. The cash position improved to $669.4 million.
Alkermes plc (Nasdaq: ALKS) has announced the 2021 recipients of its Alkermes Inspiration Grants program, awarding funds to 11 nonprofit organizations addressing the needs of individuals living with addiction, serious mental illness, or cancer. The grants prioritize programs aiding historically under-resourced communities, including BIPOC and LGBTQ+ populations. Over 250 applications were submitted, highlighting Alkermes' commitment to supporting health equity. Since 2016, the program has disbursed over $4 million to initiatives that enhance patient care beyond traditional treatment.
Alkermes plc (Nasdaq: ALKS) will hold a conference call on July 28, 2021, at 8:00 a.m. ET to discuss its second quarter 2021 financial results. The call will provide updates on the company's performance and developments in its product pipeline focused on neuroscience and oncology. Interested parties can access the call via phone or webcast through Alkermes' website. Replay options will be available shortly after the event.