Welcome to our dedicated page for Alkermes Plc news (Ticker: ALKS), a resource for investors and traders seeking the latest updates and insights on Alkermes Plc stock.
Alkermes plc (Nasdaq: ALKS) is a global biopharmaceutical company focused on neuroscience, and its news flow reflects both commercial execution and clinical development in this area. Company announcements emphasize proprietary products for alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, alongside a growing pipeline targeting neurological disorders such as narcolepsy and idiopathic hypersomnia.
Recent news has highlighted alixorexton, Alkermes investigational oral, selective orexin 2 receptor agonist. The company has reported positive phase 2 data from the Vibrance-1 study in narcolepsy type 1 and the Vibrance-2 study in narcolepsy type 2, and has announced that alixorexton is being evaluated in the Vibrance-3 study in idiopathic hypersomnia. In a separate update, Alkermes disclosed that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to alixorexton for narcolepsy type 1, based on phase 1 and phase 2 data.
Investors following ALKS news will also see regular earnings releases, where the company reports quarterly revenues, net income, EBITDA and adjusted EBITDA, and provides updates to its financial expectations. These releases describe trends in proprietary product sales, including VIVITROL, ARISTADA and LYBALVI, and manufacturing and royalty revenues related to VUMERITY and certain long-acting antipsychotic products.
Another key theme in Alkermes news is corporate transactions and financing. The company has announced a transaction agreement, and later an amendment, to acquire Avadel Pharmaceuticals plc, adding LUMRYZ, an FDA-approved once-at-bedtime oxybate for narcolepsy, to its commercial portfolio if the transaction is completed. Related filings describe an amended and restated bridge term loan credit agreement designed to support financing of the proposed acquisition.
Visitors to the ALKS news page can expect updates on clinical trial milestones, regulatory designations, quarterly financial performance, investor conference participation and material corporate agreements. This mix of scientific, financial and strategic information provides context for understanding Alkermes evolving position in neuroscience and sleep medicine.
Alkermes plc (Nasdaq: ALKS) has announced that four abstracts related to its investigational immunotherapy, nemvaleukin alfa, have been accepted for presentation at the 2022 ASCO Annual Meeting from June 3-7, 2022. A key highlight will be an oral presentation of the final dataset from the ARTISTRY-1 clinical trial, showcasing the safety and effectiveness of nemvaleukin combined with pembrolizumab. Additionally, three trial-in-progress posters will provide updates from ongoing ARTISTRY trials, further exploring nemvaleukin's potential in treating advanced solid tumors.
Alkermes reported Q1 2022 revenues of $278.5 million, up from $251.4 million YoY, driven by strong sales of LYBALVI®, ARISTADA®, and VIVITROL®. Net sales of proprietary products rose to $171.3 million, with LYBALVI generating $13.9 million. However, a GAAP loss per share of $0.22 was noted, compared to $0.14 the previous year. Total operating expenses increased to $305.1 million. Alkermes reiterated its financial expectations for the year, emphasizing growth in its proprietary portfolio amidst a challenging landscape.
Alkermes plc (Nasdaq: ALKS) will host a conference call on April 27, 2022, at 8:00 a.m. ET to discuss its first quarter financial results. The call will provide updates on the company's performance and future outlook. Investors can access the live webcast and slides through the Alkermes website. For participation, U.S. callers can dial +1 877 407 2988, while international callers can use +1 201 389 0923. A replay of the event will be available shortly after its conclusion.
Alkermes plc (Nasdaq: ALKS) has initiated binding arbitration with Janssen Pharmaceutica regarding two license agreements associated with NanoCrystal® Technology. Janssen partially terminated these agreements in February 2022 and has ceased paying royalties on related product sales in the U.S. Alkermes disputes Janssen's stance and asserts that royalties are still owed. Efforts for a mutual settlement have failed, leading to arbitration under CPR rules. This arbitration could impact Alkermes' financial position depending on the outcome.
On April 7, 2022, Alkermes plc (Nasdaq: ALKS) presented new data from the ENLIGHTEN-Early study of LYBALVI® (olanzapine and samidorphan) at the Schizophrenia International Research Society Congress in Florence, Italy. This Phase 3b study focused on body weight effects in young adults with schizophrenia and related disorders. Additionally, Alkermes shared findings on cognitive impairment assessments for patients switching to ARISTADA®. The presentations highlight Alkermes' commitment to addressing serious mental illnesses.
Alkermes plc (Nasdaq: ALKS) announced that CEO Richard Pops will participate in a fireside chat at the Stifel 2022 CNS Days on March 29, 2022, at 8:30 a.m. ET. The event will be accessible via a live webcast on the company's website, with an archive available for 14 days afterward. Alkermes is a global biopharmaceutical company based in Dublin, focusing on innovative treatments in neuroscience and oncology, including products for alcohol dependence, opioid dependence, schizophrenia, and bipolar disorder.
Alkermes plc (Nasdaq: ALKS) will present data on nemvaleukin alfa, an investigational immunotherapy, at the Society of Gynecologic Oncology 2022 Annual Meeting from March 18-21, 2022. The focus will be on outcomes from the ARTISTRY-1 study in platinum-resistant ovarian cancer patients, with a plenary oral presentation scheduled for March 19. Additionally, a poster on the ongoing ARTISTRY-7 study will be presented, comparing nemvaleukin plus pembrolizumab against chemotherapy. These studies aim to evaluate the safety and effectiveness of nemvaleukin in cancer treatment.
On February 17, 2022, Alkermes plc (Nasdaq: ALKS) presented new findings from the ARTISTRY-1 clinical trial of nemvaleukin alfa at the ASCO GU Cancers Symposium. The data demonstrate significant anti-tumor activity in patients with advanced renal cell carcinoma (RCC) treated with nemvaleukin as a monotherapy, particularly in those previously treated with checkpoint inhibitors. Key findings include a 60% reduction in target lesions for some patients and a notable immune response. Safety data align with previous reports, showing manageable adverse events without treatment-related deaths.
Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2021, showing total revenues of $324.5 million for Q4 2021 and $1.17 billion for the year, reflecting a year-over-year increase. Net income for Q4 was $0.9 million, a significant turnaround from a net loss of $42.6 million in the same quarter of the previous year. However, the company anticipates a GAAP net loss of $180 to $210 million for 2022, primarily due to the expected loss of royalties from long-acting INVEGA products. Alkermes aims to drive long-term profitability and shareholder value creation.
Alkermes announces positive topline results from the ENLIGHTEN-Early phase 3b study of LYBALVI (olanzapine and samidorphan) in young adults (ages 16-39) with schizophrenia, schizophreniform disorder, or bipolar I disorder. The study met its primary endpoint, showing less weight gain in patients treated with LYBALVI (mean: 4.91%) compared to olanzapine (mean: 6.77%, p=0.012) at week 12. Secondary endpoints also favored LYBALVI in weight gain percentages and symptom severity. Safety profiles were consistent with prior studies, with a majority of patients completing the trial.