Alkermes Plc Stock Price, News & Analysis

Alkermes announced the publication of a NIDA-funded study in the New England Journal of Medicine, investigating the safety and efficacy of extended-release injectable naltrexone (XR-NTX) combined with oral bupropion for treating methamphetamine use disorder (MUD). The study involved 403 adults with moderate to severe MUD over 12 weeks, showing a significant improvement in response rates for those receiving the combination therapy versus placebo. With no FDA-approved treatments for MUD currently available, Alkermes aims to discuss these findings with the FDA for potential therapeutic options.

Alkermes plc (Nasdaq: ALKS) will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:00 a.m. EST. CEO Richard Pops will lead the virtual session, which includes a question and answer segment. The presentation can be accessed under the Investors tab on Alkermes' website and will be archived for 14 days. Alkermes specializes in developing innovative medicines for neuroscience and oncology, with a focus on addiction and schizophrenia. The company is headquartered in Dublin, Ireland.

Alkermes plc (Nasdaq: ALKS) announced new executive appointments on January 6, 2021, including Blair C. Jackson as Chief Operating Officer and Iain M. Brown as Chief Financial Officer, replacing James M. Frates, who departs after 20 years. Jackson will oversee global operations, while Brown will manage the finance organization, enhancing leadership during the implementation of the Value Enhancement Plan. The company continues to focus on delivering value to stakeholders and expects these changes to strengthen its operational capabilities.

Alkermes plc (Nasdaq: ALKS) announced the FDA's receipt of its resubmitted New Drug Application (NDA) for ALKS 3831, aimed at treating adults with schizophrenia and bipolar I disorder. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. The resubmission was classified as a complete Class 2 response to the Complete Response Letter issued in November 2020. The FDA did not raise concerns about the clinical data and has not requested new clinical trials, enabling Alkermes to expedite the review process.

Alkermes plc (Nasdaq: ALKS) announced a Value Enhancement Plan aimed at boosting growth and shareholder value, which includes commitments to profitability targets and cost structure optimization. The plan highlights multi-year targets of 25% and 30% non-GAAP net income for FY 2023 and FY 2024, respectively. Alkermes will also review non-core assets for potential monetization and enhance corporate governance by adding two new independent directors. The company continues to focus on the commercial launch of ALKS 3831 and progressing its drug pipeline amidst a supportive dialogue with shareholders.

Alkermes plc (Nasdaq: ALKS) received a Complete Response Letter from the FDA regarding its NDA for ALKS 3831, a treatment for schizophrenia and bipolar I disorder. The FDA noted that certain manufacturing conditions must be resolved before approval. No clinical data concerns were raised, and Alkermes believes the issues have been addressed. The company plans to submit additional data to the FDA and work closely to resolve the outstanding items. ALKS 3831 has shown consistent efficacy and safety in clinical studies, with 27 studies forming the basis of the NDA.

Alkermes plc (Nasdaq: ALKS) has rescheduled its third quarter financial results conference call to 10:30 a.m. ET on October 29, 2020, due to technical difficulties with the conference call provider. The call will be accessible via a webcast on Alkermes' website. Additionally, a replay will be available until November 5, 2020. Alkermes focuses on developing innovative medicines in neuroscience and oncology, with products targeting addiction and schizophrenia, alongside a promising pipeline for various disorders.

Alkermes plc (Nasdaq: ALKS) reported Q3 2020 revenues of $265 million, up from $255.2 million year-over-year. The GAAP net loss was nearly eliminated at $0.1 million, compared to a loss of $52.9 million last year. Non-GAAP net income rose to $41.5 million, or $0.26 per share. VIVITROL sales dipped 6% due to COVID-19 but grew 12% sequentially, while ARISTADA sales increased 16%. Alkermes raised its 2020 revenue guidance to $1.01-$1.035 billion, and net income expectations align with pre-COVID guidance. The FDA reviews for ALKS 3831 are pending, with a decision expected by Nov. 15, 2020.