TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ:SNY) have reported positive outcomes from a Phase 3 trial of Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) who have not responded adequately to antihistamines. The results, presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting, indicate that Dupixent significantly reduced itch and hive activity scores from baseline, compared to placebo.
The study, known as LIBERTY-CUPID Study C, involved 151 participants who received either Dupixent or placebo alongside standard antihistamine treatment. At the 24-week mark, those treated with Dupixent experienced a greater reduction in itch severity and urticaria activity. Additionally, 41% of Dupixent recipients achieved well-controlled disease status, versus 23% on placebo.
CSU is a debilitating skin condition characterized by unpredictable episodes of itching and hives, affecting over 300,000 people in the U.S. who have not found relief with antihistamines. Dupixent, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, has been approved for CSU in Japan and the UAE and is under review in the European Union.
Safety results from the study were consistent with Dupixent's known safety profile in its approved dermatological indications. The most common adverse events in the Dupixent group included injection site reactions, accidental overdose, and COVID-19 infection.
Regeneron and Sanofi plan to resubmit regulatory filings for Dupixent in the U.S. by year-end. If approved, Dupixent would become the first new targeted treatment for CSU in the country in over a decade. Dupixent is currently approved in over 60 countries for various conditions, with over one million patients being treated worldwide.
The LIBERTY-CUPID Phase 3 program for CSU includes other studies as well, with Dupixent showing potential to significantly alleviate symptoms for patients, as noted by Thomas B. Casale, M.D., Professor of Internal Medicine.
This news is based on a press release statement and the information has not been independently verified by the Wall Street Journal. The safety and efficacy of Dupixent for CSU outside Japan and the UAE have not been fully evaluated by any regulatory authority.
In other recent news, Regeneron Pharmaceuticals has been the focus of various financial and legal developments. The company reported a 12% increase in total revenues to $3.55 billion, with Dupixent global revenues rising by 29% to $3.56 billion. Regeneron also disclosed a pre-tax charge of about $56 million for acquired in-process research and development related to collaboration and licensing agreements, expected to impact net income per diluted share by about $0.43 for the third quarter of 2024.
Regeneron's drug Dupixent received approval for treating Chronic Obstructive Pulmonary Disease in the U.S. and China, a development that TD Cowen believes could represent a $2-3 billion opportunity. However, Regeneron faces a legal challenge from Amgen (NASDAQ:AMGN) over patents related to its product, Eylea. A preliminary court decision favored Amgen, prompting Erste Group to downgrade Regeneron's rating from Buy to Hold.
Analyst firms have updated their positions on Regeneron. Truist Securities revised its price target for the company, lowering it to $1,137.00 but maintaining 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. Wells Fargo adjusted its financial outlook for Regeneron, reducing the price target on the company's shares to $1,050, while maintaining its Overweight rating.
Lastly, Regeneron shared positive results from an extension study of the Phase 3 PHOTON trial, demonstrating that EYLEA HD maintained efficacy in patients with diabetic macular edema while allowing for significantly longer dosing intervals. These are some of the recent developments in Regeneron's ongoing business activities.
InvestingPro Insights
As Regeneron Pharmaceuticals (NASDAQ: REGN) reports positive outcomes for Dupixent in treating chronic spontaneous urticaria, it's worth examining some key financial metrics and insights from InvestingPro.
Regeneron's market capitalization stands at $102.03 billion, reflecting its significant presence in the biotechnology sector. The company's P/E ratio of 23.29 suggests that investors are willing to pay a premium for its earnings, possibly due to growth expectations from drugs like Dupixent.
An InvestingPro Tip indicates that Regeneron's management has been aggressively buying back shares, which could signal confidence in the company's future prospects and potentially support the stock price. This is particularly relevant given the positive trial results for Dupixent, which could lead to expanded market opportunities.
Another InvestingPro Tip notes that Regeneron operates with a moderate level of debt, which is crucial for pharmaceutical companies investing heavily in research and development. This financial stability could provide the company with the flexibility to continue pursuing innovative treatments like Dupixent.
Regeneron's revenue growth of 6.46% over the last twelve months, coupled with a strong gross profit margin of 53.27%, underscores the company's ability to generate returns from its product portfolio. The potential addition of Dupixent for CSU treatment in the U.S. market could further boost these figures.
For investors seeking more comprehensive analysis, InvestingPro offers additional tips and insights, with 12 more tips available for Regeneron Pharmaceuticals.
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