LEO Pharma to Acquire Replay for Rare Skin Disease Gene Therapy Platform

Shots: LEO Pharma has entered into a definitive agreement to acquire Replay, expanding its dermatology pipeline with Replay’s herpes simplex virus-based gene therapy platform for rare genetic skin disorders As per the deal, LEO will acquire Replay for $50M upfront, plus milestone payments & tiered single-digit royalties, while adding Replay’s HSV design and manufacturing expertise…

ByRidhi Rastogi5 hours ago

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LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

Shots: The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

ByRidhi RastogiApril 16, 2026

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LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

Shots: LEO Pharma has initiated P-III (DELTA CARE 1) trial assessing Anzupgocream vs cream vehicle for the treatment of adults with mild to sev. lichen sclerosus (LS) DELTA CARE 1 will enroll ~652 adults with LS, starting with 300 female pts for dose selection, followed by evaluation vs vehicle in ~352 additional female & male pts…

ByRidhi RastogiJanuary 21, 2026

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LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE)

Shots: China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical corticosteroids; decision expected in 2027 NDA was based on P-III (DELTA China) trial assessing Anzupgo (BID) vs vehicle in 362 Chinese pts with mod. to sev.…

ByRidhi RastogiOctober 17, 2025

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LEO Pharma Reports Data from P-III Study of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)

Shots: LEO Pharma presented data from the P-III (DELTA TEEN) study, showing delgocitinib cream efficacy vs. cream vehicle in adolescents (12–17yrs.) with moderate to severe CHE; 63.5% achieved IGA-CHE treatment success vs. 29.2% with vehicle Delgocitinib cream also showed an edge across key 2EPs, including a ≥90% improvement (HECSI-90: 71.6% vs. 37.5%; HESD itch: 64.8%…

ByPrince GiriSeptember 19, 2025

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LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

ByRidhi RastogiJuly 24, 2025

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BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

Shots: LEO Pharma has entered into an exclusive global license & transfer agreement with BI to commercialize & advance the development of Spevigo (spesolimab) As per the deal, LEO Pharma will handle commercialization & further development of Spevigo in exchange for $105.18M (€90M) upfront, along with milestones & tiered royalties; closing expected in H2’25, subject…

ByRidhi RastogiJuly 14, 2025

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LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Shots: LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry Trial met its 1EP, with higher proportion of…

ByRidhi RastogiJuly 10, 2025

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Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Shots: Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…

BySenior EditorJanuary 21, 2025

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Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Shots: Gilead has entered into a strategic collaboration with LEO Pharma to develop the latter’s small molecule oral STAT6 programs targeting various inflammatory disorders As per the terms, Gilead secures worldwide rights to develop, manufacture & commercialize LEO’s preclinical STAT6 inhibitors & degrading proteins, with LEO having the option to co-commercialize them for dermatology…

BySenior EditorJanuary 13, 2025

LEO Pharma to Acquire Replay for Rare Skin Disease Gene Therapy Platform

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE)

LEO Pharma Reports Data from P-III Study of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

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