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Eli Lilly Wins FDA Nod for Extended Ebglyss Dosing in Eczema Care
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Key Takeaways
LLY won FDA approval for every-8-week Ebglyss maintenance dosing in eczema, reducing yearly injection count.
Ebglyss extension-study data showed durable disease control and no new safety signals with Q8W dosing.
LLY expanded Ebglyss access via major PBM agreements, reaching 94% of commercially insured patients.
Eli Lilly (LLY - Free Report) announced that the FDA has approved a new maintenance dosing regimen for Ebglyss (lebrikizumab-lbkz) for adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis (also called eczema). The drug is indicated for patients whose disease is not adequately controlled with topical prescription therapies or who cannot use such treatments.
Ebglyss is already approved in the United States and the EU for the treatment of moderate-to-severe atopic dermatitis in eligible adults and adolescents. The therapy can be used with or without topical corticosteroids and is positioned as a first-line biologic option for patients whose disease remains inadequately controlled despite topical treatment.
The latest FDA approval introduces a maintenance regimen of one 250 mg injection every eight weeks after an initial induction period and achievement of an adequate clinical response. Previously, approved maintenance treatment was administered once every four weeks.
By reducing the number of maintenance injections to as few as six per year, the new schedule offers patients greater convenience while maintaining long-term disease control. The less frequent dosing approach may also help reduce treatment burden and improve adherence among patients managing a chronic skin condition.
Shares of Eli Lilly have gained 6.5% year to date compared with the industry’s 4% growth.
Image Source: Zacks Investment Research
Rationale Behind FDA Approval of LLY's Ebglyss Q8W Dosing
The FDA approval was supported by longitudinal exposure-response modeling and data from the phase III ADjoin extension study, which evaluated whether patients with eczema who had achieved disease control with Ebglyss could maintain efficacy and safety on a less frequent every-eight-week (Q8W) maintenance regimen.
The 32-week extension study enrolled adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis who had completed the long-term ADjoin study and other late-stage studies. The enrolled patients received Ebglyss 250 mg either every eight weeks (Q8W) or every four weeks, regardless of their prior dosing schedule or treatment response.
The extension study results showed durable disease control with Q8W dosing while preserving the therapy's established safety profile. No new safety signals emerged during the extension period and no patients discontinued treatment because of adverse events. The findings demonstrated that a reduced-frequency maintenance regimen could deliver durable efficacy without compromising safety, supporting the FDA's approval decision.
Lilly holds exclusive development and commercialization rights for Ebglyss in the United States and all markets outside Europe. In Europe, rights to develop and market Ebglyss for dermatology indications, including atopic dermatitis, have been licensed to Almirall.
Lilly has expanded access to Ebglyss in the United States through coverage agreements with all three major U.S. pharmacy benefit managers, giving 94% of commercially insured patients access through national health plans. LLY has also broadened Medicaid coverage, while pursuing wider Medicare access and provides co-pay assistance and support services for eligible, commercially insured patients.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 85.6% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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Eli Lilly Wins FDA Nod for Extended Ebglyss Dosing in Eczema Care
Key Takeaways
Eli Lilly (LLY - Free Report) announced that the FDA has approved a new maintenance dosing regimen for Ebglyss (lebrikizumab-lbkz) for adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis (also called eczema). The drug is indicated for patients whose disease is not adequately controlled with topical prescription therapies or who cannot use such treatments.
Ebglyss is already approved in the United States and the EU for the treatment of moderate-to-severe atopic dermatitis in eligible adults and adolescents. The therapy can be used with or without topical corticosteroids and is positioned as a first-line biologic option for patients whose disease remains inadequately controlled despite topical treatment.
The latest FDA approval introduces a maintenance regimen of one 250 mg injection every eight weeks after an initial induction period and achievement of an adequate clinical response. Previously, approved maintenance treatment was administered once every four weeks.
By reducing the number of maintenance injections to as few as six per year, the new schedule offers patients greater convenience while maintaining long-term disease control. The less frequent dosing approach may also help reduce treatment burden and improve adherence among patients managing a chronic skin condition.
Shares of Eli Lilly have gained 6.5% year to date compared with the industry’s 4% growth.
Image Source: Zacks Investment Research
Rationale Behind FDA Approval of LLY's Ebglyss Q8W Dosing
The FDA approval was supported by longitudinal exposure-response modeling and data from the phase III ADjoin extension study, which evaluated whether patients with eczema who had achieved disease control with Ebglyss could maintain efficacy and safety on a less frequent every-eight-week (Q8W) maintenance regimen.
The 32-week extension study enrolled adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis who had completed the long-term ADjoin study and other late-stage studies. The enrolled patients received Ebglyss 250 mg either every eight weeks (Q8W) or every four weeks, regardless of their prior dosing schedule or treatment response.
The extension study results showed durable disease control with Q8W dosing while preserving the therapy's established safety profile. No new safety signals emerged during the extension period and no patients discontinued treatment because of adverse events. The findings demonstrated that a reduced-frequency maintenance regimen could deliver durable efficacy without compromising safety, supporting the FDA's approval decision.
Lilly holds exclusive development and commercialization rights for Ebglyss in the United States and all markets outside Europe. In Europe, rights to develop and market Ebglyss for dermatology indications, including atopic dermatitis, have been licensed to Almirall.
Lilly has expanded access to Ebglyss in the United States through coverage agreements with all three major U.S. pharmacy benefit managers, giving 94% of commercially insured patients access through national health plans. LLY has also broadened Medicaid coverage, while pursuing wider Medicare access and provides co-pay assistance and support services for eligible, commercially insured patients.
Eli Lilly and Company Price and Consensus
Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote
LLY’s Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 85.6% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.