Nemolizumab

Galderma Laboratories has landed a blow on Sanofi in its multi-case advertising row, driving the French drugmaker to change or drop certain claims about its blockbuster medicine Dupixent. Last year, the BBB National Programs’ National Advertising Division (NAD) ruled against Galderma in two cases brought by Sanofi. In October, the NAD recommended that Galderma change or drop some claims about Nemluvio, an IL-31 drug that, like Dupixent, is used to treat prurigo nodularis (PN) and eczema. Two months later, the NAD recommended that Galderma change or drop other claims about Nemluvio. Now, Galderma has struck back. Following a challenge by Galderma, the NAD recommended that Sanofi change or drop claims linking Dupixent to long-lasting clearer skin and fast itch relief. The U.S. advertising self-regulatory body also advised Sanofi to change or drop a prescriber-facing Day 2 itch relief claim. The NAD found that Sanofi’s evidence supports claims that some adults achieved clearer skin lasting four months to one year and that some experienced itch relief two weeks after the first dose. However, the advertising body recommended that Sanofi revise its TV claims to “clearly and conspicuously” disclose the response rate and that Dupixent was used in combination with topical corticosteroids. An animated consumer-facing mechanism-of-action video likely conveyed the unsupported message that inhibition of IL-4 and IL-13 signaling alone is sufficient to address eczema, the NAD said. Dupixent targets IL-4 and IL-13. Sanofi’s prescriber-facing claim that Dupixent reduced itch “starting as early as Day 2” was another cause of contention. The NAD found the post hoc analysis underpinning the claim failed to support Sanofi’s message that Dupixent demonstrated a meaningful treatment benefit beginning as early as Day 2. In its advertiser statement, Sanofi said that it “will comply with NAD’s recommendations.” Galderma’s challenges to other Sanofi claims failed. The NAD found support for claims that Dupixent helps patients “stay ahead of eczema” and can “help heal your skin from within,” as well as for Sanofi’s statement that many adults saw 90% clearer skin. Sanofi can continue to make the 90% claim, although the NAD recommended against overstating the supporting evidence or obscuring the treatment context. The NAD sided with Sanofi on the question of whether its ads conveyed the message that Dupixent is superior to all other FDA-approved eczema treatments. Galderma also failed to persuade the NAD that the challenged ads implied Dupixent prevents eczema progression and blocks the most important source of inflammation. Sanofi and Galderma are rowing over ads amid a fight for market share. Dupixent is a multi-indication commercial juggernaut, generating sales of 5.2 billion euros ($6 billion) for Sanofi in the second quarter. But the more recently launched Nemluvio is starting to carve out a place in two indications treated by Sanofi’s drug. Sales of Nemluvio, which the FDA approved in 2024, grew (PDF) more than 100% to $433 million in the first half of 2026. The U.S. accounted for most sales, and eczema was a bigger contributor than PN. In the U.S. from mid-June to early July, Nemluvio accounted for 42% of new patient starts in PN and 9% in eczema, Galderma said.

Attovia Therapeutics has accreted a hefty $289 million from its IPO to power its anti-itch drugs through clinical development, marking another upsized listing in what has become a banner year for biotech Nasdaq debuts. After initially hoping to bring in around $182.4 million by selling 12.5 million shares priced between $15 and $17 apiece, Attovia later updated its plans to aim for $265.1 million in net proceeds. Wednesday, the biotech revealed it ultimately sold 17 million shares priced at $17. The resulting $289 million in gross proceeds could be boosted by a further $43.3 million should underwriters fully take up their option to buy an additional 2.5 million shares at the same price. The company's stock will trade on the Nasdaq under the ticker “ATTO.” The Silicon Valley-based company has been on a biotech speedrun, securing three fundraises and now an IPO to go along with phase 1 data for its lead asset after just three years of existence. Attovia plans to use the IPO haul to kick off two large phase 2 studies next year for ATTO-1310, an engineered biologic that blocks the itch-inducing interleukin-31 (IL-31). These trials will focus on chronic pruritus of unknown origin and a subset of atopic dermatitis patients who experience high levels of itchiness, Attovia CEO Tao Fu told Fierce in an interview. But the ultimate potential for a chronic itch drug is substantial, he said. “Chronic itch is a huge disease burden impacting ... over 15 million people in the U.S.,” Fu said. The severity of chronic itch—which can lead to skin damage, sleep loss, depression and even suicidal thoughts—is often underappreciated because itch is viewed as a symptom rather than a disease worth treating in its own right, the CEO pointed out. “This has an immense impact on their quality of life, and right now there's really no effective therapy,” Fu said. “We actually have a forecast of over $11 billion peak sales for ATTO-1310 in just the core indications.” Attovia’s platform, licensed from Alamar Biosciences, allows for the modular construction of molecules that can hit numerous targets, according to Fu. The company calls these molecules “attobodies.” The CEO described these attobodies as “like Lego pieces” with binding arms built to hit multiple pieces of the same target. While ATTO-1310 hits just one target, Attovia’s pipeline also boasts a bispecific for IL-31 and IL-13, as well as a trispecific for TL1A, IL-23 and integrin α4β7. While these assets, respectively called ATTO-2306 and ATTO-1091, are still in preclinical development, Fu intends to push them into phase 1 testing early next year. ATTO-1310 faces one approved challenger in the form of Galderma’s Nemluvio, which is approved for atopic dermatitis and is in development for chronic pruritus. But otherwise the market is vastly underserved, and Attovia has argued its approach to targeting IL-31 is superior to first-in-class Nemluvio’s. While Galderma’s drug binds to IL-31’s receptor, ATTO-1310 is designed to cling to IL-31 itself. “We actually believe by targeting the ligand, we can achieve stronger or deeper and faster itch relief,” Fu said, noting that ATTO-1310 may also allow for less frequent dosing. The bispecific ATTO-2306, on the other hand, is meant to directly face off against Sanofi and Regeneron’s blockbuster inflammation med Dupixent. “Dupi is going to be biosimilar in 2031,” Fu said. “You have to set the bar very high for a biologic to challenge Dupi in that context. You basically have to outperform on both efficacy and dosing—that's how we are designing the molecule.” The trispecific ATTO-1091 is in development for inflammatory bowel disease, another heavily crowded indication. In general, Fu said he could see Attovia ultimately commercializing its assets through partnerships with Big Pharma or on its own depending on the specific indication. Attovia’s quick pace through the biotech lifecycle has been enabled by its platform, Fu told Fierce, which uses a “secret sauce” of an “evolution-driven approach” to rapidly screen prospective attobodies for desired characteristics. “You actually don't need to do a lot of optimization,” Fu said. “These attobodies come out of the ‘assembly line’ [and] pretty much have the properties we're looking for.” While the California biotech’s near-term goal is to succeed in ATTO-1310’s dual phase 2 studies and then march on to phase 3, the long-term vision is to roll more and more medicines off the attobody assembly line. While inflammation and immunology is the focus right now, Fu sees no reason for Attovia to limit itself—aside from human capital constraints. “We really have no restrictions,” the CEO said. “We have a lot of ideas, but I’ll also say we have only 45 people right now. We need to be focused.”