Regeneron's FDA Setback on Eylea HD Dosing 'No Biggie,' Says Oppenheimer

Regeneron Pharmaceuticals (NASDAQ: REGN) faced a regulatory hiccup this month when the FDA issued a Complete Response Letter (CRL) rejecting its proposal to extend EYLEA HD’s dosing intervals to every 24 weeks for certain eye diseases. Yet, Oppenheimer analysts remain bullish, arguing the setback is a manageable speed bump rather than a roadblock for the drug’s future. With another key EYLEA HD application under Priority Review and a robust pipeline, Regeneron’s stock may still have significant upside potential.

The FDA’s Specific Concerns—and Why They’re Controllable

The FDA’s CRL focused solely on Regeneron’s proposal to stretch EYLEA HD dosing intervals beyond every 16 weeks. While the agency acknowledged no safety or efficacy issues with the drug’s current dosing (every 8–16 weeks for wet age-related macular degeneration and diabetic macular edema), it deemed the evidence from the PULSAR trial’s open-label extension insufficient to support 24-week intervals. This decision, while disappointing, aligns with the FDA’s cautious approach to extended dosing regimens, especially for chronic conditions.

Critically, the FDA did not revoke existing approvals for EYLEA HD, and Regeneron retains the option to resubmit with additional data. Oppenheimer analysts noted that the rejection was partially anticipated, given the trial’s design limitations. The firm emphasized that the current dosing intervals remain commercially viable and that Regeneron’s strategic focus on reducing injection frequency—already a key advantage over competitors—remains intact.

A Silver Lining in the Priority Review

While the 24-week setback is notable, Regeneron has another major regulatory milestone ahead. A separate sBLA for EYLEA HD, submitted on April 17, is under Priority Review for two new indications:
1. Macular edema following retinal vein occlusion (RVO), a condition with limited treatment options.
2. Monthly (4-week) dosing across all approved indications, which could serve as a “rescue” option for patients needing more frequent injections.

If approved by the August 19, 2025, deadline, this application would make EYLEA HD the first anti-VEGF therapy for RVO with an 8-week dosing interval after an initial monthly period. The QUASAR Phase 3 trial demonstrated non-inferior visual outcomes compared to standard EYLEA dosing, with a manageable safety profile—though ocular hypertension occurred in 5% of patients, versus 1.7% in the control group.

Analysts See Value in the Long Game

Despite the CRL, Oppenheimer maintained its Outperform rating and $925 price target for Regeneron, citing the stock’s ~62% upside from current levels. The firm argued that the FDA’s rejection of the 24-week proposal had already been priced into the stock, while the RVO application’s success could catalyze a rebound.

Analyst consensus reinforces this optimism. As of April 2025, Regeneron’s average brokerage recommendation of 2.0 (“Outperform”) and a one-year price target of $907.96 reflect investor confidence in its pipeline. GuruFocus’s $905.96 valuation estimate further suggests the market may underappreciate the drug’s long-term potential.

Why the Setback Isn’t a Dealbreaker

The FDA’s decision underscores a broader theme in drug regulation: extended dosing intervals require rigorous, phase-specific data. Regeneron’s existing EYLEA HD label already offers longer intervals than competitors like Roche’s Lucentis or Novartis’s Beovu, which typically require monthly injections. Even without 24-week dosing, EYLEA HD’s current profile reduces patient burden significantly—a major selling point for ophthalmologists and patients.

Moreover, the RVO indication, if approved, could open a new $500 million–$1 billion market for Regeneron, according to industry estimates. With EYLEA HD’s safety profile proven across multiple trials and its dominance in wet AMD and DME markets, the drug’s commercial viability remains strong.

Conclusion: Regeneron’s Upside Outweighs the Downside

The FDA’s rejection of the 24-week dosing extension is a minor setback in Regeneron’s broader narrative. With EYLEA HD’s current advantages, the Priority Review’s potential windfall, and a robust pipeline (including its Alzheimer’s drug Aduhelm and monoclonal antibody therapies), the company is positioned to deliver shareholder value.

Crunching the numbers: At a current price of ~$558.56, Regeneron’s stock trades well below the $907.96 consensus target. Even if the RVO application faces delays, the drug’s existing markets and upcoming trials for other indications (e.g., diabetic retinopathy) provide a safety net. Oppenheimer’s “No Biggie” assessment holds water—this is a company with staying power in a high-growth sector. Investors looking for a play on ophthalmic innovation would be wise to consider Regeneron’s long-term prospects.

The path forward is clear: Regeneron must navigate FDA negotiations with patience while capitalizing on its near-term wins. If history is any guide, the market will reward that strategy.