On Monday, BMO Capital maintained its outperform rating on shares of Regeneron (NASDAQ:REGN) Pharmaceuticals, with a steady price target of $1,082.
The firm's stance comes after the U.S. Food and Drug Administration (FDA) decided that new data from the BOREAS and NOTUS studies will be considered a major amendment to the original application for approval of Dupixent in treating Chronic Obstructive Pulmonary Disease (COPD).
This decision has resulted in a delay of approximately three months for the Prescription Drug User Fee Act (PDUFA) goal date, which is now set for September 27, 2024.
The analyst from BMO Capital noted that while the delay in Dupixent's approval process might slightly affect Regeneron's stock at the opening of the market, it is not believed to comment on the drug's efficacy. Dupixent, which is already a significant revenue generator for Regeneron, is estimated to reach $2.9 billion in sales for the treatment of COPD.
The delay announcement follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, which underscores the confidence in Dupixent's efficacy. Despite the postponement, the analyst's outlook for Regeneron remains positive, reflecting an anticipation of continued success for Dupixent in the market.
Regeneron Pharmaceuticals, listed on NASDAQ:REGN, is expected to navigate the delay without major issues, given the strong performance and potential of Dupixent in its existing and prospective markets. The analyst's reiteration of the outperform rating and the price target suggests confidence in the company's long-term value proposition, despite the near-term regulatory delay.
InvestingPro Insights
Regeneron Pharmaceuticals (NASDAQ:REGN) continues to capture the attention of investors and analysts alike. According to InvestingPro data, the company boasts a robust market capitalization of $106.9B and an adjusted P/E ratio of 25.23, reflecting investor confidence in its earnings capacity. With a revenue growth of 5.9% over the last twelve months as of Q1 2024, Regeneron's financial health appears stable, underpinned by a gross profit margin of 51.31%, which is indicative of its efficient operations.
InvestingPro Tips highlight that Regeneron's management has been proactively engaging in share buybacks, a sign that could be interpreted as management's confidence in the company's value. Moreover, the company is recognized as a prominent player in the Biotechnology industry, with cash flows that can sufficiently cover interest payments and liquid assets that exceed short-term obligations. These factors, combined with a moderate level of debt, provide a solid financial foundation for Regeneron.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available, offering insights into the company's valuation multiples, profitability predictions, and stock price movements. With the current price trading near its 52-week high and analysts predicting the company will be profitable this year, Regeneron presents an interesting case for potential investors. To explore these tips and more, consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
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