Bimekizumab

iStock, Yta23 After a Phase 2 flop, Brinsupri exits the race to market for the chronic skin disease hidradenitis suppurativa, but other companies, including Incyte, Novartis and UCB, have recently notched clinical and regulatory victories. Insmed will no longer develop its recently approved lung disease drug Brinsupri for a skin condition called hidradenitis suppurativa after a disappointing mid-stage showing, leaving more room for other drugmakers in this space to forge ahead. Data from the Phase 2b CEDAR study, disclosed in a news release on Tuesday , showed “no signal of efficacy,” according to analysts at William Blair, telling investors in a note the same day that the placebo arm outperformed both Brinsupri doses that Insmed studied. Indeed, the biotech reported that at 16 weeks, total abscess and inflammatory nodule count dropped by 45.5% and 40.3% in patients on 10-mg and 40-mg Brinsupri, respectively, whereas placebo comparators saw a 57.1% reduction in the same endpoint. CEDAR also missed its secondary endpoints, Insmed said on Tuesday without specifying what those were or providing specific data. Following the mid-stage miss, Insmed will scrap the development of Brinsupri in hidradenitis suppurativa. That clears the way for other drugmakers, many of which have seen clinical and regulatory success in the condition in recent weeks. Incyte’s JAK1 inhibitor povorcitinib, for instance, maintained significant clinical benefit through 54 weeks of follow-up in two Phase 3 studies presented at the recently concluded American Academy of Dermatology meeting. Similarly, UCB announced in October last year that its IL-17A and IL-17F blocker Bimzelx sustained symptom improvements through three years of follow-up. The FDA approved Bimzelx for hidradenitis suppurativa in November 2024 . Earnings Insmed Jumps on ‘Blowout’ Sales Beat for Bronchiectasis Drug Brinsupri Insmed’s freshly approved lung condition drug soared past sales expectations for 2025, netting $144.6 million in its first full quarter of sales. January 9, 2026 · 1 min read · Dan Samorodnitsky Read more Also in the game is Novartis, which in October 2023 secured the FDA’s greenlight for Cosentyx as the first new biologic for the skin disease in almost a decade. Last month, the pharma expanded Cosentyx’s label to also include pediatric patients 12 years and up. “We are not surprised by the negative results,” analysts at Guggenheim Partners told investors in a Tuesday note, referring to Insmed’s CEDAR outcome. The firm had assigned only a 10% probability of success to the study, which reflected “the company’s own low expectations for this trial.” The bearish view of CEDAR, the analysts continued, was driven by “the lack of established animal models” for hidradenitis suppurativa and “the absence of compelling pre-clinical data” to back Brinsupri’s mechanism of action for the disease. William Blair was likewise unsurprised by CEDAR’s failure, additionally pointing to Brinsupri’s previous failure in a mid-stage rhinosinusitis study. Data released in December 2025 showed that placebo again numerically outperformed both 4-mg and 10-mg doses of Brinsupri at easing sinus symptoms in patients with chronic rhinosinusitis without nasal polyps. Brinsupri is an orally available DPP1 inhibitor that works by suppressing pro-inflammatory cascades. The drug was approved for non-cystic fibrosis bronchiectasis in August 2025, becoming the first treatment for the disease and the first DPP1 blocker cleared by the FDA. In January, Insmed reported $144.6 million in fourth-quarter sales for Brinsupri—a figure that William Blair in a Jan. 9 note called a “blowout sales performance.”

The Belgian drugmaker plans to hire about 330 people at a facility that will use advanced manufacturing technologies including AI, robotics and automation to meet rising demand for key products. This will be UCB’s first biologics manufacturing facility in the U.S. UCB is investing $2 billion to build its first biologics manufacturing facility in the U.S., putting down roots in Georgia to support products including the psoriasis drug Bimzelx. Belgium-based UCB unveiled plans to build a biologics manufacturing facility in the U.S. last year. At that time, the drugmaker was undertaking a feasibility study to determine the ideal U.S. location. UCB said it was prioritizing regions with strong talent pipelines, an essential consideration for a company seeking to hire at a time when many businesses are preparing to staff new U.S. production sites. UCB has chosen Gwinnett County, Georgia, on the outskirts of Atlanta as the location of its manufacturing facility, the state’s governor announced Tuesday. The company plans to build a 460,000-square-foot plant in the county. UCB’s facility will create about 330 permanent manufacturing jobs, plus more than 1,000 construction roles, and will use advanced manufacturing technologies including AI, robotics and automation, the company said. The company is the first global tenant at a 2,000-acre campus that is under construction in Rowen. Officials at the Rowen development said they expect design and construction to take six to seven years. The UCB project follows years of public investment in infrastructure such as water and sewer capacity to get the site ready to host companies. Gwinnett County has committed more than $174 million in incentives such as property tax savings, fee waivers and infrastructure investment to support the project. Georgia Governor Brian Kemp said a team traveled to Belgium to pitch to UCB leaders earlier this year. The efforts have secured the largest capital investment in Gwinnett County’s history. UCB’s new manufacturing location is about 40 miles from its U.S. headquarters, which is northwest of Atlanta in the city of Smyrna. The presence of the University of Georgia, Emory University, Spelman, Georgia Gwinnett College and Georgia Tech in the region could give UCB the talent pipeline it prioritized in its search for a U.S. manufacturing base. The investment follows calls by the Trump administration for biopharma companies to make medicines in the U.S. UCB also faces pressures to meet demand for Bimzelx, an IL-17A/IL-17F blocker that the FDA approved for use in plaque psoriasis in 2023. U.S. Bimzelx sales increased almost sixfold last year, jumping to almost 1.7 billion euros ($2 billion) to make the autoimmune drug the company’s best-selling product. Speaking on an earnings call last month, UCB CEO Jean-Christophe Tellier said the U.S. manufacturing investment will support Bimzelx production. UCB has also scaled up partnerships with contract manufacturers in the U.S. The content above comes from the network. if any infringement, please contact us to modify.