After a challenging year marked by regulatory and manufacturing issues, Regeneron has seen its shares recover significantly. The company’s stock reached a low of $483 over the summer but rebounded to $787, surpassing its price at the start of the year.
Regeneron's difficulties began with declining sales in its Eylea franchise. In February, the company reported that Eylea sales fell 11% to $1.19 billion for the fourth quarter of 2024 due to increased competition. The downward trend continued into 2025, with first-quarter sales dropping 26% to $1.05 billion.
The situation worsened in May when itepekimab, developed in partnership with Sanofi as a follow-up to Dupixent, failed two Phase III trials. Truist Securities commented on this setback: “We were wrong.” BMO Capital Markets analysts later suggested that investor reaction may have been excessive at the time.
Regeneron faced further challenges when three regulatory applications for different doses and forms of Eylea were delayed because of manufacturing concerns at a third-party site previously owned by Catalent. One application was rejected in October. BMO noted in October: “There is a lot that needs to be fixed at Catalent, and we see a more difficult path forward for submissions that are relying on manufacturing from these facilities.”
Despite these setbacks, Regeneron experienced some positive developments throughout the year. These included success with a hearing loss gene therapy and FDA approval of Dupixent for chronic spontaneous urticaria after an earlier rejection.
Last month brought key approvals for Eylea—specifically for retinal vein occlusion and every four-week dosing—which Leerink Partners said put Regeneron “on better footing.” Following these approvals, Regeneron's stock rose from $702 to $787 within days.
BMO analysts stated: “We are starting to see progress in turning the Regeneron story around,” adding that recent share prices are now “more reflective of the reality of Regeneron’s value.”
Looking ahead, new FDA guidance requiring only one pivotal trial could reduce regulatory burdens for drugs like itepekimab and other pipeline assets such as revogrumab (an anti-myostatin obesity drug), cemdisiran (for myasthenia gravis), and early-stage allergy programs REGN5713-5715 and REGN1908-1909.
BMO now projects Regeneron's stock could reach $850 per share as Dupixent expands into new patient populations and indications such as atopic dermatitis and chronic obstructive pulmonary disease. The analysts wrote: “Despite challenges with regulatory approvals, Dupixent has remained Regeneron’s constant, growing above and beyond expectations on a regular basis.” Truist echoed this sentiment: “Dupixent remains the cornerstone of Regeneron’s growth trajectory.”
BMO concluded that while securing approval for Eylea’s pre-filled syringe remains important heading into 2026, there has already been significant improvement over the past six months.
