Abbvie Inc Stock Price, News & Analysis

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.

AbbVie and FutureGen Biopharmaceutical announced a global license agreement to develop FG-M701, a next-generation TL1A antibody for treating inflammatory bowel disease (IBD). FG-M701 is in preclinical development and aims to offer improved efficacy and less frequent dosing compared to first-generation therapies. AbbVie will receive exclusive rights to develop, manufacture, and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments, with the potential for up to $1.56 billion in additional payments and tiered royalties up to low-double digits on net sales. The collaboration aims to advance treatment options for patients with IBD.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the 2024 recipients of the BOTOX® Cosmetic Women Entrepreneur Grant. Twenty women entrepreneurs will receive $25,000 each, mentorship, and community support. This year's program saw nearly 11,000 applicants, almost double from 2023. The grant aims to address funding disparities, particularly for BIPOC women, and includes enhanced coaching and networking opportunities. The recipients' support began with a bootcamp in New York City and will continue with a ten-week Crowdfunding Coaching Accelerator program. This initiative highlights AbbVie's commitment to empowering women entrepreneurs.

AbbVie (NYSE: ABBV) has announced positive topline results from its Phase 2 PICCOLO trial of mirvetuximab soravtansine (ELAHERE®) for folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint, achieving an objective response rate (ORR) of 51.9% (95% CI 40.4 – 63.3%).

Additionally, the median duration of response (DOR), a key secondary endpoint, was reported at 8.25 months. The safety profile was consistent with previous studies, with no new safety concerns identified. Full data will be presented at an upcoming medical meeting.

Dr. Angeles Alvarez Secord from the Duke Cancer Institute highlighted the need for new treatment options in PSOC, emphasizing the trial's significance for this patient group.