TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) today shared positive results from a three-year extension study of the Phase 3 PHOTON trial, demonstrating that EYLEA HD (aflibercept) Injection 8 mg sustained visual and anatomic improvements in patients with diabetic macular edema (DME) while allowing for significantly longer dosing intervals.
The study, presented at the American Academy of Ophthalmology (AAO) Annual meeting, reported that 88% of patients treated with EYLEA HD were maintained on a dosing interval of 12 weeks or more at week 156, with 48% of patients achieving intervals of 20 weeks or longer. This extension follows initial results where 89% of EYLEA HD patients completed week 96 on a 12-week or longer dosing schedule.
Patients who switched from EYLEA (aflibercept) Injection 2 mg to EYLEA HD experienced markedly slower fluid reaccumulation in the eye, supporting the extended duration of EYLEA HD's therapeutic action. The safety profile of EYLEA HD remained consistent with that of EYLEA, with no new safety concerns emerging over the three-year period.
This extension study is part of a broader clinical trial program, including PULSAR in wet age-related macular degeneration and PHOTON in DME/diabetic retinopathy (DR), which compares EYLEA HD administered every 12 or 16 weeks to EYLEA given every 8 weeks.
Diabetic eye disease, particularly DME and DR, poses significant challenges for the millions affected, often requiring frequent medical appointments that can disrupt daily life. The latest data suggests EYLEA HD could reduce this burden with fewer injections per year while maintaining efficacy.
EYLEA HD is developed by Regeneron in collaboration with Bayer AG (ETR:BAYGN). Regeneron holds exclusive rights in the U.S., while Bayer (OTC:BAYRY) markets the drug outside the U.S., with profits shared between the companies.
These findings are based on a press release statement and contribute to the growing body of evidence supporting EYLEA HD as a treatment for DME, offering potential benefits in terms of reduced treatment frequency without compromising patient outcomes.
In other recent news, Regeneron Pharmaceuticals has experienced significant developments. The company's total revenues have increased by 12% to $3.55 billion, with Dupixent global revenues seeing a substantial 29% surge to $3.56 billion. Regeneron announced a pre-tax charge of approximately $56 million for acquired in-process research and development related to collaboration and licensing agreements, expected to affect net income per diluted share by about $0.43 for the third quarter of 2024.
Regeneron's drug Dupixent was approved for treating Chronic Obstructive Pulmonary Disease (COPD) in the United States and China, a development that TD Cowen believes could represent a $2-3 billion opportunity. However, the company faces a legal challenge from Amgen (NASDAQ:AMGN) over patents related to its product, Eylea. A preliminary court decision favored Amgen, potentially impacting Regeneron's market share and sales growth, leading Erste Group to downgrade Regeneron's rating from Buy to Hold.
In response to these developments, several analyst firms have updated their positions on Regeneron. Truist Securities revised its price target for the company, lowering it to $1,137.00 from the previous $1,200.00 but maintained a Buy rating. BMO Capital Markets maintained its Outperform rating and $1,300.00 price target, while TD Cowen reiterated a Buy rating and a price target of $1,230.00.
InvestingPro Insights
Regeneron Pharmaceuticals' positive results from the EYLEA HD extension study align with the company's strong market position and financial performance. According to InvestingPro data, Regeneron boasts a substantial market capitalization of $107.4 billion, reflecting investor confidence in its product pipeline and growth potential.
The company's revenue growth of 6.46% over the last twelve months and a quarterly growth of 12.32% in Q2 2024 suggest that Regeneron's innovative treatments, including EYLEA HD, are driving sales momentum. This growth is particularly noteworthy given the competitive nature of the biotechnology industry.
InvestingPro Tips highlight Regeneron's financial strength, noting that "Cash flows can sufficiently cover interest payments" and the company "Operates with a moderate level of debt." These factors provide Regeneron with the financial flexibility to continue investing in research and development for products like EYLEA HD.
Moreover, Regeneron's profitability is underscored by its healthy gross profit margin of 53.27% and operating income margin of 30.14% for the last twelve months. This financial health supports the company's ability to fund ongoing clinical trials and bring new treatments to market.
Investors should note that Regeneron's stock has shown a strong performance, with a 20.85% total return over the past year. This outperformance aligns with the InvestingPro Tip stating that the company has delivered a "Strong return over the last five years."
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Regeneron Pharmaceuticals, providing a comprehensive view of the company's financial health and market position.
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