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WILMINGTON, Del. - Incyte (NASDAQ:INCY), a $13.1 billion biopharmaceutical company with robust 14.8% revenue growth over the past year, today announced successful results from its Phase 3 STOP-HS clinical trials evaluating povorcitinib, an oral treatment for moderate to severe hidradenitis suppurativa (HS). According to InvestingPro analysis, the company maintains a strong financial health rating, positioning it well for continued research and development initiatives. The trials met their primary endpoints, showing significant improvement in symptoms for patients taking the drug compared to those on placebo.
The STOP-HS1 and STOP-HS2 studies each enrolled around 600 adult patients with moderate to severe HS, a chronic inflammatory skin condition. The primary measure of success was the achievement of HiSCR50, which indicates a 50% reduction in abscess and inflammatory nodule count without an increase in abscess or draining tunnel count by Week 12. Povorcitinib showed a higher proportion of patients reaching this goal at both 45 mg and 75 mg doses versus placebo.
In addition to the primary endpoint, povorcitinib demonstrated a rapid onset of response, including a reduction in skin pain. The safety profile was consistent with previous data, and no new safety concerns were identified.
"These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide," stated Steven Stein, M.D., Chief Medical Officer at Incyte. The company plans to present detailed results at upcoming scientific meetings.
HS significantly impacts patients’ quality of life, causing painful nodules and abscesses that can lead to scarring. Current treatments are limited, and there is a need for more effective therapies.
Povorcitinib, also known as INCB054707, is a selective JAK1 inhibitor that is being investigated for several inflammatory conditions. The positive outcome from the STOP-HS trials brings hope for a new oral therapy option for individuals living with HS.
The company will hold an analyst and investor call today from 8:00-9:00 a.m. ET to discuss these results further. This announcement is based on a press release statement from Incyte.
In other recent news, Incyte Corporation has been actively engaging in various developments that are of interest to investors. The company’s recent presentation at the American Academy of Dermatology Annual Meeting showcased Phase 3 trial results for its ruxolitinib cream, Opzelura. The TRuE-PN1 trial met its primary and secondary endpoints, while the TRuE-PN2 trial did not achieve a statistically significant outcome, though it showed positive trends. Analysts from TD Cowen have maintained a Buy rating with a price target of $88, citing significant prescription growth for Opzelura and its expansion outside the U.S. as promising factors.
In terms of financial outlook, TD Cowen has noted strong performances from Incyte’s products, Opzelura and Jakafi, in the recent quarter, aligning with consensus expectations for 2025. On the other hand, RBC Capital Markets has lowered the price target for Incyte to $68 from $70, maintaining a Sector Perform rating. This decision reflects concerns over the expiration of Jakafi’s exclusivity and less optimistic guidance for Opzelura, despite a solid quarter for the company.
Additionally, Incyte has entered a strategic collaboration with Genesis Therapeutics to utilize AI for discovering new small molecule drugs, with potential milestone payments up to $295 million per target. This partnership aims to accelerate the development of novel therapeutics in Incyte’s pipeline. Overall, the company’s recent activities, including clinical trials and strategic partnerships, continue to shape its outlook in the biopharmaceutical industry.
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