Alkermes Plc Stock Price, News & Analysis

Alkermes plc (Nasdaq: ALKS) announced its participation in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on February 24, 2021, at 9:20 a.m. ET. The event will be accessible via the Investors tab on their website and will be archived for 14 days. Alkermes is a global biopharmaceutical company focused on medicine development in neuroscience and oncology, with a portfolio centered on addiction and schizophrenia treatments, and a pipeline targeting various disorders.

Alkermes plc (Nasdaq: ALKS) reported its financial results for Q4 and the full year 2020, highlighting total revenues of $280 million for Q4, down from $412.7 million YoY. The annual revenue was $1.04 billion, a decline from $1.17 billion in 2019. The company experienced a net loss of $110.9 million for 2020, narrowed from a loss of $196.6 million in the prior year. For 2021, Alkermes forecasts revenues between $1.1 billion and $1.17 billion, alongside expected net losses of $85-125 million. The company emphasizes growth from new drug launches and ongoing clinical programs.

Alkermes plc (Nasdaq: ALKS) will host a conference call on February 11, 2021 at 8:00 a.m. ET to discuss its fourth quarter and year-end 2020 financial results. Management will outline financial expectations for 2021 and provide company updates. The presentation can be accessed via the investor section on Alkermes' website. A replay of the call will be available from February 11 to February 18, 2021. Alkermes is focused on developing innovative medicines in neuroscience and oncology, with a diverse product pipeline targeting various mental health and cancer disorders.

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.