We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck's Tulisokibart Meets Endpoints in Hidradenitis Suppurativa Study
Read MoreHide Full Article
Key Takeaways
MRK's tulisokibart met the HiSCR50 endpoint, with high and medium-dose groups being superior to placebo.
High and medium-dose tulisokibart regimens produced greater quality-of-life improvements than placebo.
Merck plans phase III HS development as tulisokibart advances across six immune-mediated indications.
Merck (MRK - Free Report) announced that the phase IIb MK-7240-012 study, which evaluated its investigational pipeline candidate, tulisokibart, in patients with moderate to severe hidradenitis suppurativa (“HS”), has met the primary endpoint.
HS is a chronic, non-contagious inflammatory skin condition.
What Did MRK’s Latest Data in HS Show?
Data from the study showed that treatment with both the high-dose and medium-dose of tulisokibart demonstrated superiority over placebo at week 16, thereby meeting the endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50).
Specifically, 72% of patients receiving the high dose of tulisokibart (480 mg every two weeks) and 64% receiving the medium-dose regimen (480 mg every four weeks) achieved HiSCR50, compared with 35% of patients in the placebo group.
In an exploratory analysis, 52% of patients receiving the low-dose regimen of tulisokibart (240 mg every four weeks) achieved HiSCR50, a 17% improvement over the placebo arm.
Treatment with tulisokibart also showed numerical improvements on the non-ranked key secondary endpoint of HiSCR75 at week 16. The response rates were 41% for the high-dose group, 40% for the medium-dose group and 29% for the low-dose group, compared with 15% for placebo.
Tulisokibart also demonstrated improvements in quality of life, with the high and medium-dose groups showing greater reductions in Dermatology Life Quality Index scores from baseline than placebo.
Year to date, shares of Merck have rallied 40.9% compared with the industry’s rise of 14.9%.
Image Source: Zacks Investment Research
More on Merck’s Tulisokibart Development Activities
Tulisokibart is an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A). Per management, the candidate was designed to address immuno-fibrosis, a key driver of HS disease progression.
Per the company, the above results represent the first positive phase II data for an anti-TL1A monoclonal antibody in dermatology, underlining the potential of tulisokibart for meaningful improvement in HS. Merck plans to advance tulisokibart into phase III development for HS.
The company is also evaluating tulisokibart in multiple immune-mediated inflammatory diseases. Along with HS, the candidate is currently being studied across six indications, including phase III studies in ulcerative colitis and Crohn’s disease, as well as phase II studies in rheumatoid arthritis, psoriatic arthritis and radiographic axial spondyloarthritis.
Tulisokibart was added to MRK’s portfolio following the acquisition of Prometheus Biosciences in 2023.
Over the past 60 days, the Zacks Consensus Estimate for AC Immune’s 2026 loss per share has narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 have remained unchanged at 17 cents per share. ACIU’s shares have lost 16.6% year to date.
AC Immune’s earnings beat Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, the Zacks Consensus Estimate for Amarin’s 2026 loss per share has narrowed from 65 cents to 39 cents. Over the same period, 2027 loss per share has narrowed from 51 cents to 50 cents. AMRN’s shares have decreased 6.9% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 62.27%.
Over the past 60 days, estimates for Arcutis Biotherapeutics’ 2026 earnings per share have risen from 16 cents to 42 cents, while estimates for 2027 have increased from 96 cents to $1.14 during the same time. ARQT’s shares have declined 9% year to date.
Arcutis Biotherapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 41.39%.
View the Zacks #1 Rank List
Image: Bigstock
Merck's Tulisokibart Meets Endpoints in Hidradenitis Suppurativa Study
Key Takeaways
Merck (MRK - Free Report) announced that the phase IIb MK-7240-012 study, which evaluated its investigational pipeline candidate, tulisokibart, in patients with moderate to severe hidradenitis suppurativa (“HS”), has met the primary endpoint.
HS is a chronic, non-contagious inflammatory skin condition.
What Did MRK’s Latest Data in HS Show?
Data from the study showed that treatment with both the high-dose and medium-dose of tulisokibart demonstrated superiority over placebo at week 16, thereby meeting the endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50).
Specifically, 72% of patients receiving the high dose of tulisokibart (480 mg every two weeks) and 64% receiving the medium-dose regimen (480 mg every four weeks) achieved HiSCR50, compared with 35% of patients in the placebo group.
In an exploratory analysis, 52% of patients receiving the low-dose regimen of tulisokibart (240 mg every four weeks) achieved HiSCR50, a 17% improvement over the placebo arm.
Treatment with tulisokibart also showed numerical improvements on the non-ranked key secondary endpoint of HiSCR75 at week 16. The response rates were 41% for the high-dose group, 40% for the medium-dose group and 29% for the low-dose group, compared with 15% for placebo.
Tulisokibart also demonstrated improvements in quality of life, with the high and medium-dose groups showing greater reductions in Dermatology Life Quality Index scores from baseline than placebo.
Year to date, shares of Merck have rallied 40.9% compared with the industry’s rise of 14.9%.
Image Source: Zacks Investment Research
More on Merck’s Tulisokibart Development Activities
Tulisokibart is an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A). Per management, the candidate was designed to address immuno-fibrosis, a key driver of HS disease progression.
Per the company, the above results represent the first positive phase II data for an anti-TL1A monoclonal antibody in dermatology, underlining the potential of tulisokibart for meaningful improvement in HS. Merck plans to advance tulisokibart into phase III development for HS.
The company is also evaluating tulisokibart in multiple immune-mediated inflammatory diseases. Along with HS, the candidate is currently being studied across six indications, including phase III studies in ulcerative colitis and Crohn’s disease, as well as phase II studies in rheumatoid arthritis, psoriatic arthritis and radiographic axial spondyloarthritis.
Tulisokibart was added to MRK’s portfolio following the acquisition of Prometheus Biosciences in 2023.
MRK’s Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) , Amarin (AMRN - Free Report) and Arcutis Biotherapeutics (ARQT - Free Report) , each holding a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, the Zacks Consensus Estimate for AC Immune’s 2026 loss per share has narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 have remained unchanged at 17 cents per share. ACIU’s shares have lost 16.6% year to date.
AC Immune’s earnings beat Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, the Zacks Consensus Estimate for Amarin’s 2026 loss per share has narrowed from 65 cents to 39 cents. Over the same period, 2027 loss per share has narrowed from 51 cents to 50 cents. AMRN’s shares have decreased 6.9% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 62.27%.
Over the past 60 days, estimates for Arcutis Biotherapeutics’ 2026 earnings per share have risen from 16 cents to 42 cents, while estimates for 2027 have increased from 96 cents to $1.14 during the same time. ARQT’s shares have declined 9% year to date.
Arcutis Biotherapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 41.39%.