Incyte INCY announced positive results from two late-stage studies evaluating the safety and efficacy of its twice-daily ruxolitinib cream 1.5% in adults with prurigo nodularis (PN). The data readout from both studies was recently presented at the 2025 American Academy of Dermatology Annual Meeting.

PN is a chronic inflammatory skin condition causing intense itching and thickened red nodules, primarily on the arms, legs, and trunk. Affecting around 200,000 people in the United States, it is most common in individuals aged 40-69. Persistent scratching leads to nodules, significantly impacting sleep and overall quality of life.

Please note that ruxolitinib cream 1.5%, a topical JAK1/2 inhibitor, is currently approved in the United States under the brand name Opzelura for treating nonsegmental vitiligo in patients aged 12 and older. It is also approved for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients of the same age group whose condition is not well-managed with topical prescription therapies.

In the past three months, shares of Incyte have lost 2.3% against the industry’s 0.6% growth.

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Data Readout From INCY’s TRuE-PN1 Study for Opzelura

Incyte announced that the phase III TRuE-PN1 study achieved its primary endpoint, showing that a significantly higher percentage of PN patients using Opzelura experienced a ≥4-point improvement in the Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 compared to the vehicle control (44.6% vs. 20.6%). Notable itch relief was observed as early as Day 7 with Opzelura compared to vehicle control (22.4% vs. 8%), with numerical improvements seen at even earlier time points.

The study also met all key secondary endpoints, demonstrating the effectiveness of Opzelura compared to the vehicle control. At Week 12, significantly more patients using Opzelura achieved treatment success on the Investigator's Global Assessment for Stage of Chronic Prurigo (IGA-CPG-S-TS) (15.8% vs. 3.9%). Additionally, overall treatment success, defined by both WI-NRS4 response and IGA-CPG-S-TS achievement, was notably higher in the Opzelura group (11.9% vs. 2.9%).

Furthermore, Opzelura provided earlier itch relief, with significantly more patients achieving a WI-NRS4 response by Week 4 compared to the vehicle control (29.7% vs. 12.7%). These findings highlight the cream’s potential for improving symptoms in patients with PN.

Data Readout From INCY’s TRuE-PN2 Study for Opzelura

In the same press release, Incyte announced top-line data from the phase III TRuE-PN2 study of Opzelura. Per the data readout, treatment with the cream resulted in a strong positive trend across all key secondary endpoints, particularly for IGA-CPG-S-TS at Week 12 and WI-NRS4 at Day 7.

However, the study’s primary endpoint failed to reach statistical significance despite being in favor of Opzelura compared to the vehicle due to high placebo response. INCY will present data from the TRuE-PN2 study at an upcoming scientific meeting.

The company further reported that Opzelura was generally safe and overall well-tolerated by PN patients in both late-stage studies. The drug’s safety profile was consistent with previous data and no new safety signals were observed.

Per Incyte, the results from the phase III TRuE-PN1 and TRuE-PN2 studies will guide upcoming discussions with regulatory authorities to outline the next steps.

Incyte Corporation Price and Consensus

Incyte Corporation price-consensus-chart | Incyte Corporation Quote

INCY’s Zacks Rank and Stocks to Consider

Incyte currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Gilead Sciences GILD, BioMarin Pharmaceutical BMRN and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, Gilead Sciences’ earnings estimates for 2025 have improved from $7.60 to $7.87 per share. During the same timeframe, the earnings per share for 2026 have improved from $7.92 to $8.27. In the past three months, shares of Gilead Sciences have gained 27.1%.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 earnings per share have increased from $4 to $4.24. Estimates for 2026 earnings per share have increased from $5.16 to $5.25 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 9.5%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has increased from $1.66 to $1.84. The estimate for 2026 earnings per share has increased from $2.86 to $3.05. In the past three months, shares of Corcept Therapeutics have lost 7.8%.

CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.

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