The US Food and Drug Administration's rejection of Regeneron Pharmaceuticals' (REGN) bid to extend the dosing interval in the Eylea HD label is "no biggie," Oppenheimer said in a note Monday.

Regeneron said late Friday that the FDA issued a complete response letter denying its request to allow for extended dosing intervals of Eylea HD 8 mg across all approved indications. The therapy treats retinal conditions such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

Oppenheimer noted the company had been exploring this dosing flexibility as a potential boost to the drug's launch. While the firm believed the strategy had potential, it said the FDA's rejection wasn't entirely unexpected, as the supporting data came primarily from an open-label extension of the pulsar study.

More concerning, Oppenheimer said, is the potential readthrough for another pending application, to add a 4-week rescue regimen to Eylea HD's label. That labeling update is viewed as more critical for physician adoption and competition with Roche's Vabysmo, which already includes the 4-week option.

While the 4-week application has already been accepted by the FDA with a decision due Aug. 19, the firm warned that if it relies on similar data, it could face the same regulatory pushback. Still, Oppenheimer said there's precedent for 4-week dosing in both Vabysmo's label and Eylea HD's existing loading doses, suggesting the FDA might view this differently.

Oppenheimer reiterated its outperform rating on Regeneron and has a $925 price target on the company.

Regeneron shares were falling nearly 1% in recent trading.

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