Itepekimab

iStock, Aryo Hadi The discontinuation of the uveitis study adds to Regeneron’s series of clinical setbacks, including the Phase 3 failures of the Dupixent follow-up itepekimab and an investigational combo regimen for melanoma. Regeneron has terminated a Phase 1/2 study of an investigational anti-inflammatory antibody, which was being tested for non-infectious uveitis. The decision to end the trial is due to an “unfavorable benefit-risk assessment” of the candidate, called REGN7041, according to a federal clinical trials database . A company spokesperson confirmed the discontinuation to BioSpace via email on Tuesday morning, noting that “this decision follows an updated risk-benefit assessment for the study treatment, prompted by a thorough review of a safety event observed in the trial.” The spokesperson did not specify what the safety event was, noting only that Regeneron has conducted an investigation into the event and that the cause “has not been identified.” REGN7041 is a monoclonal antibody that targets CD3, a marker found on immune cells that drives the inflammatory cascade. Non-infectious uveitis is an eye disease characterized by inflammation of a layer of the eye. Common symptoms include redness, pain, sensitivity to light and compromised eyesight. There hasn’t yet been an anti-CD3 therapy approved for uveitis. The discontinuation of the uveitis study continues somewhat of a losing streak for Regeneron. In May last year, for instance, the pharma announced that itepekimab—an interleukin-33 blocker that many had been eyeing as a follow-up to Dupixent— failed one of two late-stage chronic obstructive pulmonary disease trials. A year later, the pharma’s investigational melanoma combo kneeled to Merck’s Keytruda in a Phase 3 trial. Earnings Regeneron’s ‘aversion’ to M&A questioned as bumper Q2 builds war chest Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks. July 30, 2026 · 2 min read · Nick Paul Taylor Read more In the face of these setbacks, analysts have been piling on the M&A pressure as a way for Regeneron not just to beef up its pipeline, but also make use of what BMO Capital Markets last month called the pharma’s “financial strength.” The company, for its part, has clarified that it is not “allergic to any external opportunity,” CEO Leonard Schleifer said during a second quarter investor call in July. “We look at them all, but we are pretty disciplined in trying to create value with these transactions.” While it’s true that Regeneron hasn’t signed a mega-deal in a while, the pharma has indeed been looking externally for innovation. Just in the past few months, the pharma has inked a handful of partnerships, including one with Telix in April, putting up to $4.3 billion on the line to advance radiopharmaceutical programs for several cancer indications. Shortly after, Regeneron linked up with Parabilis Medicines in a deal that could potentially reach $2.3 billion, hoping to unlock a new class of medicines called antibody-helicon conjugates to address previously undruggable targets. Deals Regeneron, Parabilis set out to create new drug class in deal worth up to $2.3B Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline. May 18, 2026 · 2 min read · Gabrielle Masson Read more Editor’s note (Aug. 18): The story and headline have been updated to include information from a Regeneron spokesperson.

iStock, BeritK Since stepping in as Sanofi’s CEO in April, Belén Garijo has launched a deep look at the pharma’s pipeline, reassessing assets based on “scientific merit” and potential for long-term value in the quest for a Dupixent follow-up. Sanofi has suspended a Phase 2 study testing an investigational antibody in non-cystic fibrosis bronchiectasis, as new CEO Belén Garijo reassesses the company’s pipeline. The pause was driven by “strategic business reasons to facilitate internal portfolio review,” and not because of the asset’s safety or benefit/risk profile, according to a federal clinical trials database . The asset in question is called SAR445399, a monoclonal antibody designed to block the interleukin-1 receptor 3 (IL-1R3), a key player in immune-related signaling cascades. The drug came to Sanofi in December 2015 when the pharma inked a research and license collaboration with MAB Discovery. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Sanofi’s pipeline page lists SAR445399 as under mid-stage development for hidradenitis suppurativa. That study remains open and recruiting as of July 1. Sanofi has no pipeline entry for the asset in non-cystic fibrosis bronchiectasis. BioSpace has reached out to the pharma for more color on the matter. Sanofi is amid what Garijo calls a “very rigorous portfolio prioritization process.” Garijo, who took the reins in April succeeding former chief executive Paul Hudson , revealed this effort during the company’s second quarter earnings call last week, noting that “we are going to look very deeply at our current late-stage portfolio.” The decision to push an asset forward, she said, will depend on “scientific merit, potential to create long-term value and, obviously, ensuring the right risk pro our pipeline moving forward.” Earnings Sanofi’s new CEO wants more ‘realistic view’ of Phase 3 go/no-go decisions Sanofi is going to “look very deeply” at its late-stage pipeline as part of a portfolio prioritization initiative, though new CEO Belén Garijo didn’t commit to shelving a specific number of assets. July 30, 2026 · 2 min read · Tristan Manalac Read more That same day, Sanofi revealed that it would shelve the IL-33 inhibitor itepekimab, which was being developed for chronic obstructive pulmonary disease. Phase 3 data released in May last year were mixed: itepekimab significantly reduced exacerbations in former smokers with inadequately controlled disease in only one of two late-stage trials. Sanofi had been positioning itepekimab as a successor to its blockbuster drug Dupixent, which will lose key patent protections in the coming years . Sanofi also axed the oral TNFR blocker balinatunfib last week, after the asset failed to significantly ease psoriasis severity in a mid-stage study. Late last month, the pharma also discontinued all but one of its ongoing studies for the investigational antibody amlitelimab after a disappointing showing in a Phase 3 atopic dermatitis trial. Sanofi has also scrapped plans to amlitelimab’s approval, which the company had originally scheduled for later this year. Only a celiac disease study of amlitelimab will stay online, with data expected later this year. Sanofi obtained amlitelimab in its $1.4 billion acquisition of Kymab in 2021. In conjunction with the trial discontinuations, the pharma absorbed a €952 million ($1.1 billion) impairment loss in the second quarter. Drug Development Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations. July 24, 2026 · 3 min read · Gabrielle Masson Read more