Welcome to our dedicated page for ALXN news (Ticker: ALXN), a resource for investors and traders seeking the latest updates and insights on ALXN stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect ALXN's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of ALXN's position in the market.
Alexion Pharmaceuticals (NASDAQ:ALXN) reported positive topline results from a Phase 3 study of ULTOMIRIS (ravulizumab-cwvz) for adults with generalized myasthenia gravis (gMG). The study achieved statistical significance in its primary endpoint, showing improvement in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, with effects maintained through 52 weeks in the extension study. ULTOMIRIS demonstrated a favorable safety profile and is expected to be submitted for regulatory approval in the U.S., EU, and Japan by early 2022.
Caelum Biosciences and Alexion Pharmaceuticals (NASDAQ:ALXN) announced new Phase 2 data for CAEL-101, a potential first-in-class therapy for AL amyloidosis, presented at the EHA Congress 2021. The data supports the safety and tolerability of CAEL-101 in combination with standard therapies, with findings suggesting cardiac and renal response improvements. The ongoing Phase 3 CARES program aims to enroll approximately 370 patients globally to further evaluate CAEL-101's efficacy in treating this severe disease.
Alexion Pharmaceuticals (NASDAQ:ALXN) announced that the FDA has approved an expanded use of ULTOMIRIS (ravulizumab-cwvz) for children and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). This makes ULTOMIRIS the first FDA-approved treatment for this condition in younger patients. The approval is based on favorable interim Phase 3 study results, showing effective C5 complement inhibition without severe adverse effects. ULTOMIRIS has been the standard of care for adults with PNH since 2018 and is expected to significantly improve the quality of life for affected children.
Caelum Biosciences and Alexion Pharmaceuticals (NASDAQ:ALXN) announced the acceptance of two abstracts on CAEL-101 for e-poster presentation at the European Hematology Association (EHA) Congress 2021, scheduled from June 9 to 17, 2021. The abstracts will present new data from the Phase 2 study of CAEL-101 for AL amyloidosis, highlighting safety and tolerability in combination with standard therapy. The Phase 3 CARES program is underway, aiming to enroll approximately 370 patients globally. CAEL-101 is a first-in-class therapy potentially improving organ function by addressing amyloid deposits.
Alexion Pharmaceuticals (NASDAQ:ALXN) announced the acceptance of five abstracts for the 26th European Hematology Association (EHA) virtual Congress from June 9-17, 2021. Key highlights include data on the long-term safety of ULTOMIRIS® (ravulizumab-cwvz) in PNH patients, showing reduced thrombotic risk. New Phase 3 interim analysis data will also be presented for pediatric patients. The FDA has given priority review for ULTOMIRIS in this demographic with a PDUFA date of June 7, 2021. Presentations will be available online starting June 11, 2021.
Alexion Pharmaceuticals (NASDAQ:ALXN) reported Q1 2021 revenues of $1,636.5 million, a 13% increase from Q1 2020. Diluted EPS rose 14% to $2.86 on a GAAP basis. Key products showed growth: ULTOMIRIS sales surged 56% to $346.9 million, while STRENSIQ and KANUMA sales grew 15% and 30% respectively. R&D expenses increased to $289.1 million. The company is advancing multiple clinical trials, including ULTOMIRIS in various conditions and plans for new formulations. Upcoming regulatory approvals could further impact growth.
Alexion Pharmaceuticals (Nasdaq: ALXN) will release its financial results for Q1 2021 on April 30, 2021, ahead of the previously stated May 3 date. The company, set to be acquired by AstraZeneca, will not hold a conference call; instead, it will publish earnings materials on its Investor Relations page. The acquisition agreement, announced on December 12, 2020, includes $60 in cash and 2.1243 AstraZeneca ADSs per Alexion share, totaling approximately $39 billion. The transaction is subject to regulatory approval and is expected to close in Q3 2021.
Alexion Pharmaceuticals (Nasdaq: ALXN) will release its first-quarter financial results for 2021 on May 3, 2021, before US markets open. Due to its acquisition agreement with AstraZeneca, no conference call will be held. Shareholders will receive $60 in cash and 2.1243 AstraZeneca ADSs per share, amounting to a total consideration of $39 billion. The acquisition aims to enhance both companies' capabilities in developing innovative medicines and is expected to close in Q3 2021, subject to regulatory approvals.
Alexion Pharmaceuticals (NASDAQ: ALXN) announced three accepted abstracts for presentation at the 73rd annual American Academy of Neurology meeting from April 17-22, 2021. The abstracts focus on real-world data for SOLIRIS (eculizumab), highlighting its effectiveness in reducing myasthenic crises and hospitalizations related to generalized myasthenia gravis (gMG). Additionally, long-term efficacy data for neuromyelitis optica spectrum disorder (NMOSD) will be shared, including results from the Phase 3 PREVENT trial. The meeting will be held virtually with accessible posters throughout the event.
