Abbvie Inc Stock Price, News & Analysis

AbbVie has received a positive opinion from the European Medicines Agency's CHMP for epcoritamab (TEPKINLY®), a bispecific antibody for treating adults with relapsed/refractory follicular lymphoma (R/R FL) after two or more prior therapies. If approved, it will be the first bispecific antibody conditionally approved for both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the EU. This recommendation is based on results from the Phase 1/2 EPCORE® NHL-1 study, which showed significant overall and complete response rates. The European Commission's decision is expected later this year. Follicular lymphoma accounts for 20-30% of all non-Hodgkin's lymphoma cases, with about 13,000 cases in Western Europe in 2023. The collaboration between AbbVie and Genmab aims to secure additional international regulatory approvals.

AbbVie (NYSE: ABBV) announced the acquisition of Celsius Therapeutics, a biotechnology company focused on inflammatory diseases. This $250 million cash deal includes adjustments and aims to advance Celsius' leading investigational asset, CEL383, an anti-TREM1 antibody for treating inflammatory bowel disease (IBD). CEL383 has completed Phase 1 clinical trials and targets TREM1, a gene linked to inflammation in IBD. AbbVie believes CEL383 could help more IBD patients achieve remission, reflecting the company's commitment to expanding its immunology portfolio.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has launched Allē Payment Plans, allowing patients to pay for aesthetic treatments over time without hard credit checks. This initiative aims to make treatments like BOTOX® Cosmetic and JUVÉDERM® more accessible. Market research indicates that while over 50 million Americans are interested in facial injectables, cost remains a major barrier, with only a fraction seeking treatment annually. The pilot program showed that 54% of transactions were from new patients, and 34% included multiple brands. The national rollout of the payment plans begins today, with full availability expected in the coming months. The plans are offered at no cost to aesthetic providers for Allergan Aesthetics products, enhancing their ability to attract new patients.

The U.S. FDA has granted a second approval to AbbVie's EPKINLY® (epcoritamab-bysp) for treating adults with relapsed or refractory follicular lymphoma (R/R FL) after two or more prior therapies. This makes EPKINLY the first bispecific antibody approved in the U.S. for both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL). The approval is under the FDA's Accelerated Approval program based on overall response rates and durability of response. In clinical trials, EPKINLY showed an overall response rate of 82%, with a complete response rate of 60%. Safety evaluations included common side effects such as injection site reactions and cytokine release syndrome. EPKINLY is co-developed by AbbVie and Genmab, with AbbVie handling global commercialization.

AbbVie announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease. The CRL is due to observations from an inspection at a third-party manufacturing facility not involving ABBV-951. Importantly, the CRL does not cite any safety, efficacy, or labeling issues related to ABBV-951, nor does it request additional efficacy or safety trials. AbbVie continues to work with the FDA to expedite bringing ABBV-951 to U.S. patients.

AbbVie, a member of the S&P Dividend Aristocrats Index, announced a quarterly cash dividend of $1.55 per share.

This dividend will be payable on August 15, 2024, to shareholders who are on record by the end of business on July 15, 2024.

Since its inception in 2013, AbbVie has increased its dividend by over 285%.

AbbVie has appointed Roxanne S. Austin as the lead independent director of the board, effective July 1, 2024. She replaces Glenn F. Tilton, who has served in this role since 2013 and will continue as an independent director. CEO Richard A. Gonzalez highlighted the board's diversity and high standards of corporate governance. Roxanne Austin, who joined the board in 2013, is recognized for her experience and leadership. This transition coincides with Rob Michael taking over as CEO on July 1. Glenn Tilton endorsed Austin's appointment, praising her strategic leadership and commitment to the company.

AbbVie (NYSE: ABBV) has received U.S. FDA approval for SKYRIZI® (risankizumab-rzaa) for the treatment of moderately to severely active ulcerative colitis. This approval is based on positive results from two Phase 3 clinical trials: a 12-week induction study (INSPIRE) and a 52-week maintenance study (COMMAND). SKYRIZI is now the first IL-23 specific inhibitor approved for treating both moderate to severe ulcerative colitis and Crohn's disease. The treatment showed significant clinical and endoscopic improvements. The dosing regimen includes an initial 12-week induction followed by maintenance therapy. This approval broadens AbbVie’s portfolio in inflammatory bowel disease, demonstrating its commitment to addressing the needs of over 1 million people affected by ulcerative colitis in the U.S. The drug is available with patient support programs to reduce out-of-pocket costs for eligible patients.

AbbVie (NYSE: ABBV) advises shareholders to reject Tutanota 's unsolicited "mini-tender" offer to purchase up to 250,000 shares of AbbVie common stock at $165.00 per share. The offer, dated May 28, 2024, is conditioned on the stock's market price exceeding the offer price before the offer's expiration on June 28, 2024. AbbVie warns that accepting the offer could result in selling shares at below-market prices and highlights the lack of investor protections in mini-tender offers, as noted by the SEC. Shareholders who have already tendered their shares can withdraw them by following the instructions in Tutanota's offer documents. AbbVie emphasizes the importance of consulting financial advisors and reviewing current stock quotes before making any decisions.