AbbVie, Inc. (ABBV Quick QuoteABBV ) announced that it has submitted a regulatory application in the United States, seeking approval for its interleukin-23 (“IL-23”) inhibitor Skyrizi (risankizumab) as a potential treatment for moderate to severe Crohn’s disease (“CD”).
The regulatory filing seeks approval for Skyrizi both as a 600mg intravenous (“IV”) induction and 360mg subcutaneous (“SC”) maintenance therapy in patients aged 16 years and older with CD.
The filing is supported by data from three phase III studies — ADVANCE, MOTIVATE and FORTIFY — that evaluated the safety and efficacy of Skyrizi in CD patients. In all three studies, participants administered Skyrizi achieved co-primary endpoints of clinical remission and endoscopic response as compared to placebo.
In the year so far, Abbvie’s stock price has declined 0.7% against the industry’s 8.5% rise.
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Hot Stocks For 2023: SailPoint Technologies Holdings(SAIL)
SailPoint Technologies Holdings, Inc. provides enterprise identity security solutions in the United States, Europe, the Middle East, Africa, and internationally. The company offers software and software as a service (SaaS) solutions, which help organizations to govern the digital identities of employees, contractors, business partners, software bots, and other human and non-human users, as well as manage their constantly changing access rights to enterprise applications and data across hybrid IT environments, spanning on-premises, cloud and mobile applications, and file storage platforms. Its solutions include IdentityNow, a cloud-based multi-tenant identity security platform; IdentityIQ, an on-premises identity security solution; and SailPoint Identity Services, a multi-tenant SaaS subscription service. The company sells its products and solutions to commercial enterprises, financial institutions, and governments directly, as well as through system integrators, technology partners, and value-added resellers. SailPoint Technologies Holdings, Inc. was founded in 2004 and is headquartered in Austin, Texas.
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Sailpoint Technologies Holdings, Inc. (NYSE:SAIL) Q4 2018 Earnings Conference CallMarch 5, 2019 5:00 p.m. ET
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Hot Stocks For 2023: Gap, Inc. (GPS)
The Gap, Inc. operates as an apparel retail company worldwide. It offers apparel, accessories, and personal care products for men, women, and children under the Gap, Banana Republic, Old Navy, Athleta, and Intermix brands. The company provides apparel, eyewear, jewelry, shoes, handbags, and fragrances; and performance and lifestyle apparel for use in yoga, strength training, and running, as well as seasonal sports, including skiing and tennis. The Gap, Inc. offers its products through company-operated stores, franchise stores, Websites, e-commerce and social media sites, and catalogs. The company has franchise agreements with unaffiliated franchisees to operate Gap, Banana Republic, and Old Navy stores in Asia, Australia, Europe, Latin America, the Middle East, and Africa. As of January 30, 2016, it operated, 3,721 company-operated and franchise store locations. The company was founded in 1969 and is headquartered in San Francisco, California.