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' }); } });

Summing up Sanofi’s patchy clinical track record so far this year, the company’s head of R&D Houman Ashrafian, Ph.D., acknowledged that “drug development is a tough thing.”\n Some of Sanofi’s most high-profile readouts this year can’t have made for easy reading at the French pharma’s Paris headquarters.In April, the company revealed that its anti-OX40L-ligand antibody amlitelimab had flunked a phase 2 asthma trial. The same month, the drugmaker reported that its oral TNF inhibitor balinatunfib missed the goal of a midstage psoriasis study. Weeks later, the Regeneron-partnered IL-33 candidate itepekimab failed one of a pair of phase 3 studies in chronic obstructive pulmonary disease.Even a phase 3 win for amlitelimab—which Sanofi secured as part of its $1.1 billion acquisition of Kymab back in 2021—in atopic dermatitis (AD) earlier this month received a lukewarm reception from analysts and dented the company’s stock price.Despite these setbacks, Sanofi’s head of R&D, Houman Ashrafian, Ph.D., told Fierce Biotech that he takes a “pretty pragmatic” approach to the Big Pharma’s portfolio.“We’ve had a year which has been mixed, but that reflects the risks of drug development, particularly in immunology and inflammation, and particularly in areas where … the clinical trial space has been shaped by preexisting molecules,” Ashrafian said in an interview.The R&D chief spoke to Fierce ahead of the release of phase 2 data from Sanofi for brivekimig that the company hopes will tell a more positive story. The pharma has been assessing the anti-TNFa/OX40L nanobody in a trial of 71 patients with moderate-to-severe hidradenitis suppurativa, a rare inflammatory skin condition.While the study wasn\'t powered for statistical significance, 67% of brivekimig-treated patients saw a 50% or greater decrease in total abscess and inflammatory nodule count at week 16, a result Sanofi called “clinically meaningful.“ A total of 54% of brivekimig patients saw abscesses reduced by 75% compared to 22% of the placebo cohort.Unveiling the results ahead of a presentation at the European Academy of Dermatology and Venereology 2025 Congress in Paris, Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, said the data “exemplify our deep understanding of pathway biology and commitment to exploring novel platforms and technologies.““We are encouraged by these results and look forward to continuing to explore brivekimig, and the impact of dual TNF and OX40 ligand inhibition, on the inflammation driving the burdensome symptoms of HS,” Johnsen added in a Sept. 17 release.In his interview with Fierce days earlier, Ashrafian also alluded to the “positive study” for brivekimig, suggesting that the “OX40 ligand portfolio is looking pretty good.” The other OX40L success—at least in Sanofi\'s eyes—is the anti-OX40L antibody amlitelimab, which hit the primary endpoint of a phase 3 AD trial earlier this month by showing that 35.9% and 46%, respectively, of two patient cohorts had seen a 75% or greater improvement in their eczema.While the study was a win on paper, the results fell at the bottom end of analysts’ predictions, prompting a 9% share price decline for the French pharma in one day.When asked by Fierce whether he was surprised by the market reaction, Ashrafian pointed to the fact that the study “comfortably” hit its key endpoints, and amlitelimab appeared to be “safest in class.”“My perspective was that this was a credible result,” he said.“This is a meaningful contributor to the AD landscape, which is hugely biologically under-penetrated,” added Ashrafian, who noted that “the incumbents in AD look like they will all become blockbusters.” Not feeling the pressure One explanation that analysts gave for the high stakes placed on that amlitelimab readout was growing concerns that the failures of itepekimab and balinatunfib in the clinic this year cast doubt over how Sanofi will replace the losses accrued when Dupixent finally falls off the patent cliff around 2031.Despite being Sanofi’s head of R&D, Ashrafian denied that he feels under increased scrutiny to ensure he has a winner on his hands.“I\'m not really feeling the pressure,” he said. “I\'m excited to be doing what we\'re doing—we’ve got a great pipeline.”“It always surprises me when people say they have questions about R&D credibility,” Ashrafian said. “We\'re not going to get everything right. We\'re not perfect, but actually we\'ve got one of the best late-stage portfolios of any company in the industry today.”The late-stage portfolio includes an eagerly awaited phase 3 readout of the BTK inhibitor tolebrutinib in multiple sclerosis in the coming weeks. Despite having suffered its own clinical difficulties—namely falling short in two out of a trio of studies last year—Sanofi is still hoping to score an FDA approval in the specific indication of non-relapsing secondary progressive MS.Ashrafian also said the pharma’s leadership has “gone from good to great” in recent months with the appointment of Christopher Corsico, M.D., as Sanofi’s global head of development in May, followed by Marcia Kayath, M.D., Ph.D., taking on the chief medical officer role earlier this month. The execs previously worked at GSK and BioMarin, respectively.Summing up Sanofi’s patchy clinical track record so far this year, Ashrafian acknowledged that “drug development is a tough thing.”“I\'m humble and reflective in the face of failures, but it\'s part of our business,” he said. “If you can\'t deal with some of those slings and arrows of outrageous fortune, I think this particular job is not the one to take on.”