Alkermes Plc Stock Price, News & Analysis

Alkermes plc (Nasdaq: ALKS) presented new real-world outcomes research and clinical data related to its psychiatry portfolio at Psych Congress 2020. The research focused on treatment challenges of second-generation antipsychotics, particularly weight gain and treatment interruptions in patients with schizophrenia and bipolar I disorder, using data from 17,316 patients. Key presentations included findings on ARISTADA and ALKS 3831. The company emphasized its commitment to addressing challenges faced by those with serious mental illness.

Alkermes plc (Nasdaq: ALKS) announced participation in the Cantor Virtual Global Healthcare Conference on Sept. 16, 2020, at 10:40 a.m. ET. CEO Richard Pops will engage in a fireside chat, which can be accessed via the company's website and archived for 14 days. Alkermes is a global biopharmaceutical company focused on innovative medicines for neuroscience and oncology, with commercial products targeting addiction and schizophrenia, and a development pipeline for various mental health and cancer therapies.

Alkermes plc (Nasdaq: ALKS) will present new clinical data on ALKS 4230, its investigational IL-2 variant immunotherapy, at the ESMO Virtual Congress from September 18-21, 2020. The ARTISTRY-1 study evaluates ALKS 4230 alone and with pembrolizumab in patients with refractory solid tumors. A mini oral presentation will be hosted by Dr. Ulka N. Vaishampayan. Additionally, a webcast and conference call are scheduled for September 18 at 8:30 a.m. ET to discuss the latest findings. ALKS 4230 aims to enhance immune response while reducing immunosuppressive activity.

Alkermes plc (Nasdaq: ALKS) announced a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to review the NDA for ALKS 3831, scheduled for Oct. 9, 2020. ALKS 3831 is a novel, once-daily oral atypical antipsychotic aimed at treating schizophrenia and bipolar I disorder. The FDA's PDUFA action date for the NDA is Nov. 15, 2020. The focus will include ALKS 3831's attenuation of weight gain associated with olanzapine and potential risks related to opioid interactions.

Alkermes plc (Nasdaq: ALKS) announced the initiation of ARTISTRY-3, a phase 2 study to assess the effects of ALKS 4230 monotherapy on the tumor microenvironment in patients with advanced solid tumors. ALKS 4230, an investigational engineered fusion protein, aims to expand tumor-killing immune cells while minimizing immunosuppressive effects. The study will collect paired tumor biopsies to evaluate immunologic activity and clinical responses. This trial marks the fourth assessment of ALKS 4230, with previous studies ongoing.

Alkermes plc (Nasdaq: ALKS) announced the publication of phase 3 ENLIGHTEN-2 trial results for ALKS 3831 in the American Journal of Psychiatry. This six-month study compared the weight gain profiles of ALKS 3831 and olanzapine in 561 stable schizophrenia patients. Positive topline data was first reported in November 2018. The full manuscript is now available online. ALKS 3831 is under FDA review for treating schizophrenia and bipolar I disorder, with a PDUFA target date of November 15, 2020.

Alkermes plc (Nasdaq: ALKS) reported Q2 2020 revenues of $247.5 million, down from $279.9 million year-over-year. While VIVITROL sales declined 19% to $71.6 million, ARISTADA grew 21% to $58.8 million. The company recorded a GAAP net loss of $29.4 million or $0.19 per share, improved from a loss of $42 million a year prior. Alkermes expects 2020 total revenue between $965 million and $1,005 million, adjusting for COVID-19 impacts on its operations.

Alkermes plc (Nasdaq: ALKS) will host a conference call on July 29, 2020, at 8:00 a.m. ET to discuss its second quarter 2020 financial results. The call will provide insights into the company's performance and updates on business developments. Investors can access the webcast on Alkermes' website. A replay will be available from 11:00 a.m. ET on the same day through August 5, 2020. Alkermes, based in Dublin, specializes in neuroscience and oncology, focusing on innovative treatments for addiction, schizophrenia, and cancer.

Alkermes plc (Nasdaq: ALKS) announced the opening of applications for its annual Alkermes Pathways Research Awards program starting July 1, 2020. The program, now in its third year, supports early-career researchers focused on neuroscience, particularly in substance use disorders, schizophrenia, and bipolar disorder. Grants of up to $100,000 will be awarded to qualifying M.D.s, Ph.D.s, or post-doctoral fellows. The application period will close on October 30, 2020.