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AbbVie's (ABBV) Rinvoq Meets Key Goal in Phase II Vitiligo Study
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AbbVie (ABBV - Free Report) announced positive results from its mid-stage study evaluating Rinvoq (upadacitinib) in a new indication. The phase IIb study evaluated the 6 mg, 11 mg and 22 mg dose strengths of Rinvoq in adult patients with non-segmental vitiligo (NSV) compared with placebo.
The study met its primary endpoint of the percentage change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg dose strengths of Rinvoq.
Vitiligo is a chronic autoimmune disease characterized by the skin’s depigmentation resulting from the loss of pigment-producing cells known as melanocytes. Per AbbVie, vitiligo affects approximately 2% of the global population and takes a serious toll on the patient’s quality of life.
F-VASI is a metric for the extent of re-pigmentation of the face and treatment response in clinical studies.
At week 52, the percent reduction from baseline in F-VASI was observed to be numerically greater than the results at week 24 for all Rinvoq doses. This signified the continued efficacy of the drug in treating NSV through week 52.
Based on the positive results from the phase IIb vitiligo study, AbbVie is gearing up to initiate a phase III clinical program evaluating Rinvoq in the treatment of NSV.
AbbVie’s Rinvoq, a JAK inhibitor, was initially approved in 2019 to treat moderate-to-severe rheumatoid arthritis (RA). Currently, the drug is approved for seven indications, including RA, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis. Label-expanding studies evaluating Rinvoq in several immune-mediated diseases like giant cell arteritis, systemic lupus erythematosus, hidradenitis suppurativa and takayasu arteritis are ongoing.
Year to date, shares of AbbVie have lost 8.2% against the industry’s 8.2% rise.
Image Source: Zacks Investment Research
The phase IIb dose-ranging study enrolled 185 patients (aged 18 to 65 years) with NSV, having an F-VASI of 1.1 and a Total Vitiligo Area Scoring Index (T-VASI) of 22. The patient population was then randomized to receive either a once-daily dose of Rinvoq (22 mg, 11 mg or 6 mg) or placebofor 24 weeks of treatment.
The company also reported that treatment with Rinvoq demonstrated higher response rates in secondary endpoints compared with placebo, including a ≥75% reduction from baseline in F-VASI (F-VASI 75) at week 24 with the 11 mg and 22 mg doses. A ≥50% reduction from baseline in T-VASI (T-VASI 50), another secondary endpoint, was also observed at week 24, but only in the Rinvoq 22 mg arm.
The 52-week analysis of the secondary endpoints in the study also demonstrated numerically greater response rates observed for F-VASI 75 and T-VASI 50 than those at week 24 for all Rinvoq dose groups.
Treatment with Rinvoq did not cause any new safety issues beyond its already established safety profile. Treatment-related adverse events were mild-moderate in severity.
We would like to remind the investors that Incyte (INCY - Free Report) recently announced new positive 52-week data from its phase IIb dose-ranging study, evaluating the efficacy and safety of its pipeline candidate, povorcitinib, in adult patients with extensive NSV.
Povorcitinib is Incyte’s investigational oral small-molecule JAK1 inhibitor. Data from the phase IIb study showed that the treatment with oral povorcitinib caused substantial total body and facial repigmentation across all treatment groups at week 52.
INCY’s management claims that the 52-week study results reaffirm the previously reported positive top-line 24-week data from the phase II study and bolster the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive NSV.
Subject to successful development and approval, Incyte’s povorcitinib will provide serious competition to AbbVie’s Rinvoq in the vitiligo market.
Some better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) . Currently, DVAX sports a Zacks Rank #1 (Strong Buy) and CORT carries a Zacks Rank #2 (Buy).
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have gained 34%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. During the same period, the estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have gained 36%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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AbbVie's (ABBV) Rinvoq Meets Key Goal in Phase II Vitiligo Study
AbbVie (ABBV - Free Report) announced positive results from its mid-stage study evaluating Rinvoq (upadacitinib) in a new indication. The phase IIb study evaluated the 6 mg, 11 mg and 22 mg dose strengths of Rinvoq in adult patients with non-segmental vitiligo (NSV) compared with placebo.
The study met its primary endpoint of the percentage change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg dose strengths of Rinvoq.
Vitiligo is a chronic autoimmune disease characterized by the skin’s depigmentation resulting from the loss of pigment-producing cells known as melanocytes. Per AbbVie, vitiligo affects approximately 2% of the global population and takes a serious toll on the patient’s quality of life.
F-VASI is a metric for the extent of re-pigmentation of the face and treatment response in clinical studies.
At week 52, the percent reduction from baseline in F-VASI was observed to be numerically greater than the results at week 24 for all Rinvoq doses. This signified the continued efficacy of the drug in treating NSV through week 52.
Based on the positive results from the phase IIb vitiligo study, AbbVie is gearing up to initiate a phase III clinical program evaluating Rinvoq in the treatment of NSV.
AbbVie’s Rinvoq, a JAK inhibitor, was initially approved in 2019 to treat moderate-to-severe rheumatoid arthritis (RA). Currently, the drug is approved for seven indications, including RA, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis. Label-expanding studies evaluating Rinvoq in several immune-mediated diseases like giant cell arteritis, systemic lupus erythematosus, hidradenitis suppurativa and takayasu arteritis are ongoing.
Year to date, shares of AbbVie have lost 8.2% against the industry’s 8.2% rise.
Image Source: Zacks Investment Research
The phase IIb dose-ranging study enrolled 185 patients (aged 18 to 65 years) with NSV, having an F-VASI of 1.1 and a Total Vitiligo Area Scoring Index (T-VASI) of 22. The patient population was then randomized to receive either a once-daily dose of Rinvoq (22 mg, 11 mg or 6 mg) or placebofor 24 weeks of treatment.
The company also reported that treatment with Rinvoq demonstrated higher response rates in secondary endpoints compared with placebo, including a ≥75% reduction from baseline in F-VASI (F-VASI 75) at week 24 with the 11 mg and 22 mg doses. A ≥50% reduction from baseline in T-VASI (T-VASI 50), another secondary endpoint, was also observed at week 24, but only in the Rinvoq 22 mg arm.
The 52-week analysis of the secondary endpoints in the study also demonstrated numerically greater response rates observed for F-VASI 75 and T-VASI 50 than those at week 24 for all Rinvoq dose groups.
Treatment with Rinvoq did not cause any new safety issues beyond its already established safety profile. Treatment-related adverse events were mild-moderate in severity.
We would like to remind the investors that Incyte (INCY - Free Report) recently announced new positive 52-week data from its phase IIb dose-ranging study, evaluating the efficacy and safety of its pipeline candidate, povorcitinib, in adult patients with extensive NSV.
Povorcitinib is Incyte’s investigational oral small-molecule JAK1 inhibitor. Data from the phase IIb study showed that the treatment with oral povorcitinib caused substantial total body and facial repigmentation across all treatment groups at week 52.
INCY’s management claims that the 52-week study results reaffirm the previously reported positive top-line 24-week data from the phase II study and bolster the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive NSV.
Subject to successful development and approval, Incyte’s povorcitinib will provide serious competition to AbbVie’s Rinvoq in the vitiligo market.
AbbVie Inc. Price and Consensus
AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote
Zacks Rank and Stocks to Consider
AbbVie currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) . Currently, DVAX sports a Zacks Rank #1 (Strong Buy) and CORT carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have gained 34%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. During the same period, the estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have gained 36%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.