Alkermes Inc. plc - ALKS STOCK NEWS

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.

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.