Alkermes Plc Stock Price, News & Analysis

On October 9, 2020, Alkermes plc (Nasdaq: ALKS) announced positive outcomes from the FDA advisory committee meetings regarding ALKS 3831, a new treatment for schizophrenia and bipolar I disorder. The committees voted 16-1 in favor of ALKS 3831's ability to mitigate weight gain associated with olanzapine and 13-3-1 regarding its safety profile. The FDA's review is ongoing, with a PDUFA date set for November 15, 2020. The NDA for ALKS 3831 is backed by data from 27 clinical studies, indicating robust support for the drug's approval.

Alkermes plc (Nasdaq: ALKS) announced a temporary halt in trading of its ordinary shares as the FDA advisory committees convene to review the company's New Drug Application for ALKS 3831, an investigational treatment for schizophrenia and bipolar I disorder. The virtual meeting is scheduled for 10:00 a.m. ET today, with a PDUFA action target date of Nov. 15, 2020. These developments highlight the potential impact of ALKS 3831 in the market, considering the significant prevalence of the targeted disorders, affecting millions in the U.S.

Alkermes plc (Nasdaq: ALKS) announced that the FDA has posted briefing documents for the Oct. 9, 2020 advisory committee meeting to review its New Drug Application (NDA) for ALKS 3831, an oral atypical antipsychotic for schizophrenia and bipolar I disorder. The meeting will be held virtually at 10:00 a.m. ET. The PDUFA target action date for this NDA is Nov. 15, 2020. ALKS 3831 combines samidorphan, a new molecule, with olanzapine in a single tablet.

On September 18, 2020, Alkermes presented promising clinical data from the ARTISTRY-1 phase 1/2 study of ALKS 4230, an investigational immunotherapy. The study showed effective monotherapy in melanoma and durable responses when combined with pembrolizumab in various refractory tumors. Notable results included a 39% tumor shrinkage in patients with metastatic melanoma and a complete response in a patient with refractory ovarian cancer. The ARTISTRY program aims to enhance treatment options for patients who have not responded to standard therapies.

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.