NORTH CHICAGO, Ill. and ROCKVILLE, Md. - AbbVie (NYSE: NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $309.55 billion, and REGENXBIO Inc. (Nasdaq: RGNX) have announced progress in their collaborative efforts to develop a gene therapy, ABBV-RGX-314, for the treatment of two major eye diseases, wet age-related macular degeneration (wet AMD (NASDAQ:AMD)) and diabetic retinopathy (DR). According to InvestingPro analysis, AbbVie maintains a strong financial health score, positioning it well for continued R&D investments. These updates include the planning of a Phase 3 clinical program for DR and the anticipation of pivotal trial results for wet AMD in 2026.
ABBV-RGX-314 utilizes a NAV AAV8 vector to deliver an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF), a key factor in the formation of leaky blood vessels that contribute to vision loss in wet AMD. The therapy is being investigated as a potential one-time treatment for patients, which could significantly alleviate the chronic treatment burden associated with current anti-VEGF therapies that require frequent intraocular injections.
The collaboration between the two companies aims to advance the development of ABBV-RGX-314 through two separate delivery methods: a standardized subretinal procedure and a suprachoroidal space delivery using the SCS Microinjector, licensed from Clearside Biomedical (NASDAQ:CLSD), Inc.
Wet AMD is a leading cause of vision loss in the United States, Europe, and Japan, affecting up to two million people in these regions. Current treatments, although effective in preventing progression of vision loss, often lead to a decline in vision due to the demanding treatment regimen. With annual revenue of $55.53 billion and an impressive gross profit margin of 70.33%, AbbVie demonstrates strong commercial capabilities to potentially capitalize on this market opportunity. For deeper insights into AbbVie's financial metrics and growth potential, investors can access comprehensive analysis through InvestingPro's detailed research reports. DR, the primary cause of vision loss in working-age adults worldwide, similarly requires ongoing management, with a spectrum of treatments ranging from "watchful waiting" to anti-VEGF therapies and surgery for advanced cases.
The companies have expressed their commitment to addressing the unmet needs of patients with these debilitating diseases, with the potential for ABBV-RGX-314 to become the first one-time gene therapy for wet AMD and DR.
This news is based on a press release statement and includes forward-looking statements subject to risks and uncertainties that may cause actual results to differ materially. AbbVie and REGENXBIO have not provided any additional information beyond what is included in the press release. For investors considering AbbVie's potential, the company offers a notable dividend yield of 3.74% and has maintained dividend payments for 13 consecutive years. InvestingPro subscribers can access over 30 additional financial metrics and expert insights to make more informed investment decisions.
In other recent news, AbbVie, a global biopharmaceutical company, is set to record a non-cash after-tax impairment charge of approximately $3.5 billion related to the emraclidine intangible asset. The impairment charge results from the unsuccessful trials of emraclidine, a drug under development for schizophrenia and Alzheimer's disease. Despite this setback, AbbVie continues to observe the remaining intangible assets, valued at about $3.6 billion.
In terms of financial performance, AbbVie has adjusted its fourth-quarter earnings guidance for 2024 due to significant research and development costs, with an expected impact of $0.88 per share. This adjustment brings the company's full-year 2024 adjusted diluted earnings per share to a projected range of $10.02 to $10.06.
In the analyst arena, Truist Securities has adjusted its price target for AbbVie, reducing it to $211 from $215, while maintaining a Buy rating on the company's stock. Piper Sandler also raised its price target for AbbVie to $220, maintaining an Overweight rating on the stock.
In terms of mergers and acquisitions, AbbVie has recently acquired Nimble Therapeutics for $200 million and Aliada Therapeutics. These strategic acquisitions aim to enhance AbbVie's pipeline in immunology and inflammation, neuropsychiatry, oncology, and aesthetics.
Lastly, AbbVie reported positive results from its Phase 3 TEMPO-2 trial of tavapadon, a potential treatment for early Parkinson's disease. These are all recent developments indicating ongoing advancements and growth at AbbVie.
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