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Incyte Reports Strong 54-Week Data From Late-Stage Skin Disorder Study
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Key Takeaways
INCY reported 54-week STOP-HS data showing durable efficacy of povorcitinib in HS patients.
Povorcitinib achieved up to 71.4% HiSCR50, with higher thresholds like HiSCR75 and HiSCR100 met.
Safety remained consistent over 54 weeks, supporting favorable benefit-risk and regulatory review.
Incyte (INCY - Free Report) reported 54-week data from its late-stage STOP-HS program demonstrating substantial and sustained efficacy of povorcitinib in patients with moderate-to-severe hidradenitis suppurativa (HS).
The data was presented at the American Academy of Dermatology Annual Meeting 2026.
The STOP-HS clinical trial program includes two phase III studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836), evaluating the efficacy and safety of povorcitinib (INCB54707) in adult patients with moderate to severe HS.
Both studies include a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week double-blind extension period.
HS is a chronic inflammatory skin disorder marked by painful nodules and abscesses that may result in permanent tissue damage and scarring.
Across both STOP-HS1 and STOP-HS2 trials, treatment responses remained durable through week 54, with up to 71.4% of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50). Higher response thresholds were also notable, with up to 57% reaching HiSCR75 and up to 29% achieving complete response (HiSCR100), underscoring robust efficacy across increasingly stringent endpoints.
Povorcitinib delivered consistent reductions across key inflammatory lesion types, with complete lesion clearance (ANdT=0) observed in up to 20% of patients. These clinical benefits were complemented by meaningful improvements in patient-reported outcomes, including reductions in skin pain and fatigue.
The safety profile remained consistent with prior data, with both dose levels well tolerated over 54 weeks, supporting a favorable long-term benefit-risk profile.
More on INCY’s Povorcitinib
Povorcitinib is an oral small-molecule JAK1 selective inhibitor currently being evaluated in phase III clinical studies for moderate to severe HS (STOP-HS1, STOP-HS2, STOP- HS LTE), nonsegmental vitiligo (STOP-V1, STOP-V2) and prurigo nodularis (PN; STOP-PN1, STOP-PN2), as well as a phase II studies for moderate to severe asthma.
Incyte previously reported that both STOP-HS1 and STOP-HS2 met the primary endpoint, with povorcitinib achieving statistically significant improvements in HiSCR50 versus placebo at Week 12 across both dose arms (45 mg and 75 mg).
Following the double-blind period, patients entered a 42-week extension phase, with those on active treatment continuing their assigned doses, while placebo participants were re-randomized 1:1 to receive povorcitinib at either 45 mg or 75 mg.
The new drug application and marketing authorization application for povorcitinib, as a potential treatment for moderate to severe HS, are under review by the FDA and the European Medicines Agency, respectively.
The latest data from the STOP-HS program reinforce povorcitinib’s potential as a differentiated oral JAK1 inhibitor and support ongoing regulatory review in the United States and Europe.
Incyte expects top-line phase III data for povorcitinib in vitiligo and PN in mid-2026 and fourth-quarter 2026, respectively.
INCY’s Efforts to Expand Portfolio
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
At present, lead drug Jakafi accounts for the majority of revenues.
Shares of Incyte have surged 50.6% in the past year compared with the industry’s 14.7% growth.
Image Source: Zacks Investment Research
The lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets.
Incyte earns product royalty revenues from Novartis for the commercialization of Jakavi in ex-U.S. markets.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta contributes to its top-line growth.
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
The pipeline progress is impressive as well. Incyte expects to have 14 pivotal clinical trials underway by year-end.
Over the past 60 days, estimates for ADMA’s 2026 EPS have increased from 85 cents to 96 cents. ADMA’s shares have lost 53.3% over the past year.
Estimates for ANI Pharmaceuticals’ EPS have increased from $8.28 to $8.99 for 2026 over the said period. Over the past year, shares of ANIP have surged 9.7%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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Incyte Reports Strong 54-Week Data From Late-Stage Skin Disorder Study
Key Takeaways
Incyte (INCY - Free Report) reported 54-week data from its late-stage STOP-HS program demonstrating substantial and sustained efficacy of povorcitinib in patients with moderate-to-severe hidradenitis suppurativa (HS).
The data was presented at the American Academy of Dermatology Annual Meeting 2026.
The STOP-HS clinical trial program includes two phase III studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836), evaluating the efficacy and safety of povorcitinib (INCB54707) in adult patients with moderate to severe HS.
Both studies include a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week double-blind extension period.
HS is a chronic inflammatory skin disorder marked by painful nodules and abscesses that may result in permanent tissue damage and scarring.
Across both STOP-HS1 and STOP-HS2 trials, treatment responses remained durable through week 54, with up to 71.4% of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50). Higher response thresholds were also notable, with up to 57% reaching HiSCR75 and up to 29% achieving complete response (HiSCR100), underscoring robust efficacy across increasingly stringent endpoints.
Povorcitinib delivered consistent reductions across key inflammatory lesion types, with complete lesion clearance (ANdT=0) observed in up to 20% of patients. These clinical benefits were complemented by meaningful improvements in patient-reported outcomes, including reductions in skin pain and fatigue.
The safety profile remained consistent with prior data, with both dose levels well tolerated over 54 weeks, supporting a favorable long-term benefit-risk profile.
More on INCY’s Povorcitinib
Povorcitinib is an oral small-molecule JAK1 selective inhibitor currently being evaluated in phase III clinical studies for moderate to severe HS (STOP-HS1, STOP-HS2, STOP- HS LTE), nonsegmental vitiligo (STOP-V1, STOP-V2) and prurigo nodularis (PN; STOP-PN1, STOP-PN2), as well as a phase II studies for moderate to severe asthma.
Incyte previously reported that both STOP-HS1 and STOP-HS2 met the primary endpoint, with povorcitinib achieving statistically significant improvements in HiSCR50 versus placebo at Week 12 across both dose arms (45 mg and 75 mg).
Following the double-blind period, patients entered a 42-week extension phase, with those on active treatment continuing their assigned doses, while placebo participants were re-randomized 1:1 to receive povorcitinib at either 45 mg or 75 mg.
The new drug application and marketing authorization application for povorcitinib, as a potential treatment for moderate to severe HS, are under review by the FDA and the European Medicines Agency, respectively.
The latest data from the STOP-HS program reinforce povorcitinib’s potential as a differentiated oral JAK1 inhibitor and support ongoing regulatory review in the United States and Europe.
Incyte expects top-line phase III data for povorcitinib in vitiligo and PN in mid-2026 and fourth-quarter 2026, respectively.
INCY’s Efforts to Expand Portfolio
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
At present, lead drug Jakafi accounts for the majority of revenues.
Shares of Incyte have surged 50.6% in the past year compared with the industry’s 14.7% growth.
Image Source: Zacks Investment Research
The lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets.
Incyte earns product royalty revenues from Novartis for the commercialization of Jakavi in ex-U.S. markets.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta contributes to its top-line growth.
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
The pipeline progress is impressive as well. Incyte expects to have 14 pivotal clinical trials underway by year-end.
INCY’s Zacks Rank & Stocks to Consider
INCY currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the pharma/biotech sector are ADMA Biologics (ADMA - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), ANIP carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ADMA’s 2026 EPS have increased from 85 cents to 96 cents. ADMA’s shares have lost 53.3% over the past year.
Estimates for ANI Pharmaceuticals’ EPS have increased from $8.28 to $8.99 for 2026 over the said period. Over the past year, shares of ANIP have surged 9.7%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.