Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Shots: The P-III (ADorable‑1) study data assessed Ebglyss vs PBO in 363 pediatric pts (≥6mos.) with mod. to sev. AD; Topical corticosteroids were required for 2 wks. pre-randomization through Wk. 16, with tapering or discontinuation allowed once pts achieved IGA ≤2 At Wk. 16, the trial met it 1EP & key 2EPs, with 63% vs…

ByRidhi RastogiMarch 17, 2026

INSIGHTS+

The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

NEWS

Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

Shots: The P-II trial consists of 4 overlapping stages: Stage 1 (vs PBO) for tilrekimig & ompekimig; Stage 2 (dose-ranging) & Stage 3 (ongoing) evaluated tilrekimig, with Stage 3 involving biologic-experienced adults; Stage 4 is an ongoing ompekimig dose-ranging study Trial met its 1EP with more pts achieving EASI-75 at Wk. 16; PBO-adjusted rates were…

ByRidhi RastogiMarch 10, 2026

NEWS

Lynk Pharmaceuticals Reports Topline P-III Trial Data on Zemprocitinib in Atopic Dermatitis

Shots: Lynk has reported topline P-III trial data assessing zemprocitinib (12 or 24mg) vs PBO in 356 pts with mod. to sev. atopic dermatitis At Wk. 16, zemprocitinib (12 & 24mg) met both co-1EPs, showing superiority vs PBO in EASI-75 (+38.1% & +46.4%) & vIGA-AD 0/1 (+30.3% & +31%), & significantly improved WI-NRS4 itch response…

ByRidhi RastogiMarch 3, 2026

NEWS

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Shots: The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…

ByRidhi RastogiFebruary 11, 2026

NEWS

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…

ByDipanshu DixitJanuary 1, 2026

NEWS

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Shots: Innocare has dosed the first patient in the global P-II trial of Soficitinib (ICP-332) for the treatment of pts with prurigo nodularis in China Soficitinib was also evaluated in the P-II trial for mod. to sev. atopic dermatitis, which showed superior efficacy & favorable safety, with data presented at the AAD’25 Soficitinib, a selective…

ByRidhi RastogiNovember 28, 2025

NEWS

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitable Approval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with AD Trial met its 1EP with more…

ByRidhi RastogiOctober 16, 2025

NEWS

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…

ByRidhi RastogiOctober 15, 2025

NEWS

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

Shots: FDA approved Zoryve (0.05% roflumilast; QD) for pts (2-5yrs.) based on P-III (INTEGUMENT-PED), INTEGUMENT-OLE study & a P-I PK trial; commercially available by end of Oct 2025 INTEGUMENT-PED (n=652) showed rapid disease clearance with benefits from Wk. 1, as 25.4% vs 10.7% achieved vIGA-AD Success & a 2-grade improvement at Wk. 4; trial also met all…

ByRidhi RastogiOctober 7, 2025

Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

The US FDA New Drug Approvals in February 2026

Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

Lynk Pharmaceuticals Reports Topline P-III Trial Data on Zemprocitinib in Atopic Dermatitis

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

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