FDA Formally Rejects Regeneron’s Eylea HD Over Manufacturing Issues.
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise. The FDA has handed Regeneron a complete response letter for a pre-filled syringe formulation of its high-dose Eylea, citing problems at a third-party manufacturer. But CEO Leonard Schleifer struck an optimistic note on the company’s Q3 earnings call on Tuesday, telling investors that the pharma is already at work on a solution.
Specifically, Regeneron is working to “submit an application to add an alternate prefilled syringe filler,” Schleifer said, with the filing expected in January 2026. This action would trigger a four-month review from the FDA, he added, from which the pharma expects a favorable outcome, “given we believe there are no other outstanding review issues for this application.”
Regeneron is also tapping an alternate vial filler for an ongoing review, for which the regulator has a target action date in “late December,” Schleifer continued. This would provide an additional opportunity for the FDA to approve the supplemental biologics license applications (sBLA) for Eylea HD every four week dosing and for the treatment of macular edema following retinal vein occlusion, he said. The sBLAs have target action dates in late November.
Analysts broadly saw these developments as a positive for Regeneron. Writing to investors on Tuesday afternoon, analysts at BMO Capital Markets said they were “encouraged” by the news that the pharma is turning to a new manufacturing facility for Eylea HD. “We could finally be nearing an end of the manufacturing issues that have plagued the Eylea HD franchise since 2023.”
Truist Securities had similar sentiments, writing that the new filler site “could support near-term approval” for the high-dose injection. “If the FDA can rapidly finalize inspections at the new site,” the analysts wrote, “then Eylea HD’s . . . sBLA could be approved in November.” Truist noted that while management expects the inspection to wrap up by December, “this could happen earlier.” Investors seemed to share analysts’ positivity, with shares of Regeneron up 11.8% to $654.48 at close of trading Tuesday.
During Regeneron’s Q2 call in August, the pharma had already telegraphed trouble for its Eylea HD applications, pointing to observations at a filling site run by Novo Nordisk. Later that month, Regeneron revealed that the FDA pushed back its decision date for these applications into the fourth quarter. Then, earlier this month, Novo informed Regeneron that it had received an Official Action Indicated classification from the FDA for this specific plant, suggesting that the facility is in an “unacceptable state of compliance.” Among its violations were persistently unaddressed contaminations and the lack of a preventive mechanism for these types of issues.
In the third quarter, Regeneron posted a 1% year-on-year growth to hit $3.75 billion in revenues, driven mainly by its Sanofi-partnered blockbuster drug Dupixent, which brought in $4.86 billion. “We are encouraged to see further commercial strength from Dupixent,” BMO said on Tuesday, noting that its recent launch in chronic obstructive pulmonary disease has helped drive better uptake for the drug. Dupixent’s growth was enough to offset the 28% decline in total sales for Regeneron’s Eylea and Eylea HD franchise, which hit $1.11 billion for the quarter.
The FDA has issued Regeneron a complete response letter for its high-dose Eylea prefilled syringe, citing manufacturing issues at a third-party site. However, analysts and investors remain optimistic as the company moves swiftly to resolve the setback.CEO Leonard Schleifer said Regeneron plans to file an application in January 2026 to add an alternate syringe filler, expecting a four-month review that could clear the way for approval.
The company is also pursuing an alternate vial filler, with FDA action expected by late December. Analysts from BMO Capital Markets and Truist Securities described these efforts as encouraging signs that Regeneron may be nearing the end of its manufacturing woes, with potential approvals as early as November. Investor confidence reflected that sentiment, pushing Regeneron’s shares up nearly 12% on Tuesday. While Eylea sales fell 28% in the third quarter to $1.11 billion, the decline was offset by strong performance from Dupixent, which continues to drive the company’s overall revenue growth.
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