Itepekimab

iStock, draco77 After a series of unfortunate regulatory rejections and manufacturing issues surfaced, Regeneron’s shares dipped to $483 this summer—the lowest they’d been since early 2021. But they now sit higher than they did at the start of the year. After hitting a four-year low, Regeneron’s shares have climbed back from the brink to finish the year on a high note. The storied biopharma had a dramatic year, snarled up by regulatory and manufacturing setbacks—many of which were not of its own making. But now, with six months of hindsight, BMO Capital Markets is starting to see the bright side. “We are starting to see progress in turning the Regeneron story around,” BMO’s Evan Seigerman and his fellow analysts wrote last week. “As we approach the end of 2025, we are appreciative of the internal reflective work that Regeneron has done over the past few months.” The markets reflect the analysts’ optimism. Regeneron’s shares, which bottomed out at $483 this summer, recently clawed back to $787—comfortably more than the Jan. 1 price of $715 and representing a 10% increase for the year. Regeneron’s troubles began early in the year when cracks began to show in the company’s blockbuster Eylea franchise . Reporting fourth-quarter 2024 earnings in February, Regeneron revealed that the eye disease drug fell 11% to $1.19 billion amid growing competition in the space. The losses continued into 2025, with sales decreasing 26% to $1.05 billion for the first quarter, as reported in April. Then in May, analysts were shocked when itepekimab, a follow-up to the Sanofi-partnered stalwart Dupixent, failed to meet the sky-high expectations in a pair of Phase III trials. “We were wrong,” Truist Securities admitted at the time. Looking back, BMO now believes the reaction may have been overblown. “At the time of this trial miss, investors were understandably frustrated and largely surprised by what seemed a higher probability readout,” Seigerman and colleagues wrote. “As a result, negative sentiment had hampered the shares, potentially to an unjustified level.” For the second quarter, Regeneron showed signs of positivity by beating analyst expectations . But the company also revealed that three regulatory applications for different doses and forms of Eylea had been delayed due to manufacturing concerns at a third-party manufacturing site formerly owned by Catalent, the CDMO giant that Novo Nordisk bought last year. One of those applications was formally rejected in October. Manufacturing Biotechs Secure Alternative Fill/Finish Capacity Amid Scrutiny of Novo Site Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected. December 2, 2025 · 6 min read · Nick Paul Taylor Read More There wasn’t much for Regeneron to do but wait for the site to fix the issues to allow the Eylea applications to proceed. “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,” BMO wrote in October. Throughout the year, there have been spots of good news for Regeneron, such as the success of a hearing loss gene therapy and the approval of Dupixent for chronic spontaneous urticaria after an initial October 2023 rejection. But the company is ending the year strong. Last month, Eylea finally received two critical approvals for retinal vein occlusion and every four-week dosing . Leerink Partners said the approvals put Regeneron “on better footing.” The biotech’s stock climbed from $702 to $787 in a matter of days. Shares are “more reflective of the reality of Regeneron’s value,” BMO said. Looking ahead, Regeneron could benefit from the FDA’s newly announced plan to require only one pivotal trial , Truist Securities suggested last week. Particularly, itepekimab could see a reduced regulatory burden for future respiratory indications under this new trial guidance. Other pipeline assets such as Regeneron’s anti-myostatin obesity drug revogrumab, the myasthenia gravis therapy cemdisiran and early allergy programs REGN5713-5715 and REGN1908-1909 could also be aided by the new rules. The BMO analysts now expect the stock to rise to $850 per share thanks to growing Dupixent sales as the drug reaches its new patient population and gains more ground in atopic dermatitis and chronic obstructive pulmonary disease. “Despite challenges with regulatory approvals, Dupixent has remained Regeneron’s constant, growing above and beyond expectations on a regular basis,” BMO wrote. Truist similarly wrote at the end of November that “Dupixent remains the cornerstone of Regeneron’s growth trajectory.” Heading into 2026, BMO said Regeneron still needs to get that third approval for Eylea’s pre-filled syringe to truly turn things around. But still, the analysts wrote, “what a difference six months can make.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });