Delgocitinib

Plus, news about Leads Biolabs and Gate Bioscience: FDA approves LEO Pharma’s eczema cream: The company’s JAK inhibitor, called Anzupgo, was approved in Europe in September. It’s now approved in the US for adults with moderate-to-severe chronic hand eczema. A LEO spokesperson said the company is not disclosing the price at this time. — Jaimy Lee Abivax’s $650M offering: The French biotech upsized its stock sale of 10.2 million shares at $64 apiece after disclosing a pair of Phase 3 wins for its experimental ulcerative colitis drug earlier this week. — Jaimy Lee Another Hong Kong IPO: Leads Biolabs priced its Hong Kong Stock Exchange listing on Thursday, saying it expects 1.17 billion Hong Kong dollars (about $149 million) in net proceeds . The Chinese biotech has 14 drug candidates in development. It forged a pact with Aditum Bio last year amid the wave of China-to-West biotech licensing deals, but lost an LAG3 partnership with BeOne Medicines (formerly called BeiGene) in May. Leads’ listing follows the success of DualityBio’s $194 million IPO in Hong Kong this spring. The IPO market in the US, meanwhile, has been dry since mid-February. — Kyle LaHucik Eli Lilly strikes deal with Gate Bioscience for ‘molecular gate’ drugs: The California startup is developing what it calls “molecular gate” therapies, a new class of small molecule drugs that prevent cells from releasing disease-causing proteins by blocking the interaction between a target protein and the channel called Sec61 used to secrete it. Gate said it will get an upfront payment, equity investment,  potential milestones and royalties from Lilly worth up to $856 million. The companies did not disclose the disease focus. — Ryan Cross Galderma expects ‘significant growth’ for IL-31 drug: Nemluvio, which was approved a year ago to treat prurigo nodularis and atopic dermatitis, brought in $131 million in sales in the first half of the year. The dermatology-focused drugmaker said Thursday that it’s increasing its sales guidance for 2025 by 12% to 14%, citing its belief that Nemluvio will “drive significant growth” for its therapeutic dermatology business. — Jaimy Lee Editor’s note: The Lilly/Gate item has been updated with some of the deal’s financial details.

BALLERUP, Denmark I July 23, 2025 I LEO Pharma, a global leader in medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved ANZUPGO ® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 1 ANZUPGO is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. 1 ANZUPGO inhibits the JAK-STAT pathway, specifically blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), and suppresses the various inflammatory responses that play a key role in the onset and subsequent flares of CHE. 1,2,4 The FDA approval of ANZUPGO marks a significant milestone in LEO Pharma’s strategy to expand its presence in the U.S. market and deliver purposeful innovation in skin health. In preparation for bringing ANZUPGO to the U.S. patients, LEO Pharma has significantly upscaled its operations across key functions – including a 50% increase in the sales force. “ANZUPGO is a good example of how we transform a real need in the market into medicines that can help make a difference for people living with serious skin diseases such as CHE,” said Christophe Bourdon, CEO, LEO Pharma. “After successfully launching ANZUPGO in several countries, we’re proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States. The approval of ANZUPGO reinforces our commitment to investing in difficult-to-treat skin conditions to deliver new treatments to patients where the need is greatest. We’re truly grateful to the patients and physicians who participated in our studies and helped make this approval possible.” CHE is a highly debilitating inflammatory skin disease that affects approximately one in ten adults worldwide, causing itchy, painful, blistered, or swollen skin that can interfere with daily activities. 2,3,5,6 The FDA approval of ANZUPGO provides adults in the U.S. living with moderate-to-severe CHE with the first and only treatment option specifically approved for this skin disease, just as it will be the first and only topical pan-JAK-inhibitor on the U.S. market. “Chronic hand eczema can be a very difficult disease for adults to manage, especially given the lack of treatment options in the U.S. until now ,” said Robert Spurr, EVP and President, North America, LEO Pharma. “ As the first and only FDA-approved treatment specifically for CHE in the U.S., ANZUPGO further establishes our company’s real commitment to bringing treatments to market that address unmet needs in medical dermatology.” The FDA approval is the latest regulatory milestone for ANZUPGO, following the European Commission (EC) approval in 2024 and several launches internationally, including Germany, Switzerland, the United Kingdom and the United Arab Emirates. *Ends* About ANZUPGO ® (delgocitinib) Cream ANZUPGO ® (delgocitinib) cream is currently FDA approved in the U.S. as the first and only treatment for chronic hand eczema (CHE). ANZUPGO is also approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA. 1 ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 7 In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. The full U.S. FDA Prescribing Information and Medication Guide are available here: https://www.leo-pharma.us/AnzupgoPI About Chronic Hand Eczema Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for three or more months or relapses twice or more within a year. 5,8 HE is one of the most common skin disorders of the hands and in a substantial number of patients, it can develop into a chronic condition. 9 CHE affects approximately one in ten adults worldwide. 2,3 It is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 6 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 2 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 10,11 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities. 12 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 13 About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com . References SOURCE: LEO Pharma