Incyte (INCY Quick QuoteINCY - Free Report) announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ruxolitinib cream.

The sNDA is seeking approval of the cream for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD), a chronic immune-mediated skin condition.

The target action date has been extended by three months to Sept. 19, 2025, to provide FDA with the time to review additional chemistry, manufacturing and controls (CMC) data on the 0.75% strength submitted by Incyte in response to a recent information request by the regulatory body.

Year to date, shares of Incyte have lost 0.9% compared with the industry’s decline of 2.5%.

Image Source: Zacks Investment Research

More on INCY’s Opzelura

Ruxolitinib cream is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. It is approved by the FDA under the brand name Opzelura for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.

The sNDA was based on data from the phase III TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with AD. This study met its primary endpoint with significantly more patients treated with Opzelura, achieving Investigator’s Global Assessment-treatment success (IGA-TS) — a measure of treatment efficacy — than with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 was achieved.

Please note that Opzelura is already approved in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

First-quarter net revenues from Opzelura cream were $119 million, up +38%.

INCY’s Efforts to Diversify Portfolio

Incyte is looking to expand its portfolio and reduce dependence on lead drug Jakafi (ruxolitinib).

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.

The approval of Opzelura has been a significant boost for the company.

Other drugs like Pemazyre and newly approved drugs like Monjuvi and Tabrecta have helped INCY’s cause to diversify its portfolio.

Earlier this month, the FDA approved the label expansion of Monjuvi in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for the treatment of adult patients with relapsed or refractory follicular lymphoma, a type of slow-growing blood cancer.

Last month, the FDA approved Zynyz (retifanlimab-dlwr), a PD-1 inhibitor, in combination with platinum-based chemotherapy (carboplatin and paclitaxel) for the first-line treatment of adult patients with locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Although the uptake of recently approved drugs has been good and a potential approval of the additional drugs should diversify its portfolio, INCY is heavily dependent on Jakafi for its top-line growth.

Moreover, competition has increased for some of Jakafi’s approved indications with the FDA’s approval of GSK plc’s (GSK Quick QuoteGSK - Free Report) Ojjaara for the treatment of intermediate or high-risk MF, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia.

GSK posted strong growth in Ojjaara sales for the first quarter of 2025 (£112 million), driven by continued uptake in the United States and contributions from Europe and International regions.

Jakafi is also expected to lose patent protection in a few years.

INCY’s Zacks Rank and Stocks to Consider

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

A couple of better-ranked stocks in the pharma/biotech sector are Immunocore (IMCR Quick QuoteIMCR - Free Report) and Bayer (BAYRY Quick QuoteBAYRY - Free Report) . While IMCR sports a Zacks Rank #1 (Strong Buy) at present, Bayer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Immunocore

In the past 60 days, loss per share estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained 6.3% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.

Bayer

BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 57.9%.

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.