Regeneron anticipates FDA decision on high-dose eye drug in 2021, shares surge

Regeneron anticipates FDA decision on high-dose eye drug in 2021, shares surge

Regeneron Expects U.S. Decision on Higher-Dose Eylea in Q3, Shares Soar

Regeneron Pharmaceuticals has announced that it expects a decision from the U.S. Food and Drug Administration (FDA) on the higher-dose version of its blockbuster eye disease drug, Eylea, in the third quarter. This news comes as a surprise to the market, which had expected the decision to be delayed. In premarket trading, Regeneron’s shares surged by 5%, indicating the positive response from investors.

The FDA had previously rejected the higher-dose version of Eylea in June, citing concerns related to the inspection of third-party manufacturer Catalent. The rejection had caused Regeneron’s shares to plummet, as investors worried about the potential delay in approval. However, Regeneron now plans to submit manufacturing data required by the FDA by mid-August, and it anticipates a decision in the third quarter.

Analysts view this development as a significant positive, as many had been concerned about a potential delay that would push the approval process into 2024. By receiving a decision earlier than expected, Regeneron can avoid further delays and move forward with the commercialization of the higher-dose version of Eylea.

The approval of the higher-dose version holds strategic importance for Regeneron, as it would provide a defense against competitors such as Roche’s Vabysmo. Regeneron and its partner Bayer are betting on longer intervals between injections, made possible through the higher-dose formulation, to attract and retain patients. This innovative approach could give them a competitive edge in the market.

Although U.S. sales of Eylea dipped by 7% to $1.50 billion in the second quarter, the figure still exceeded analysts’ estimates of $1.48 billion. Moreover, Regeneron has found solace in the sales of its eczema drug Dupixent, recorded by partner Sanofi, which saw a remarkable surge of 33% to $2.79 billion in the same period. Since its approval in 2017, Dupixent has played a crucial role in offsetting the decline in Eylea sales.

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Regeneron reported adjusted profit of $10.24 per share for the second quarter, surpassing analysts’ average estimate of $9.84. This positive financial performance further reinforces the company’s strong position in the market and sets the stage for future growth and innovation.

In summary, Regeneron’s optimistic forecast for a decision on the higher-dose version of Eylea in the third quarter has generated great enthusiasm among investors. This faster-than-expected approval timeline not only allays concerns of further delays but also positions Regeneron to gain an edge over competitors. With strong financial performance and the success of Dupixent, Regeneron’s future seems promising, highlighting its commitment to improving health outcomes and advancing medical innovation.

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