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WILMINGTON, Del. - The U.S. Food and Drug Administration has extended its review period for Incyte’s (NASDAQ:INCY) supplemental New Drug Application for ruxolitinib cream (Opzelura) in children aged 2-11 years with mild to moderate atopic dermatitis, the company announced Friday. The $13.26 billion market cap pharmaceutical company, which InvestingPro analysis shows maintains a strong financial health rating, has demonstrated solid revenue growth of 17.13% over the last twelve months.
The FDA pushed the Prescription Drug User Fee Act action date by three months to September 19, 2025, to review additional chemistry, manufacturing and controls data for the 0.75% strength formulation submitted by Incyte in response to an information request. According to InvestingPro data, the company maintains a healthy current ratio of 2.04, indicating strong operational flexibility to manage such regulatory timelines.
"We are confident in the potential of ruxolitinib cream to become an important non-steroidal, topical treatment option for pediatric patients with atopic dermatitis," said Steven Stein, Chief Medical Officer at Incyte, in a press release statement.
The application is based on data from the Phase 3 TRuE-AD3 study, which met its primary endpoint with significantly more patients achieving Investigator’s Global Assessment treatment success compared to those receiving vehicle control. The study also met a secondary endpoint measuring 75% improvement in the Eczema Area and Severity Index at week 8.
According to the company, the safety profile in the pediatric trial was consistent with previous data, with no serious infections, major adverse cardiovascular events, malignancies or thromboses reported during the 8-week vehicle-controlled period. The most common treatment-related adverse event was application site pain.
Opzelura is currently approved in the U.S. for treating nonsegmental vitiligo in patients 12 years and older, as well as for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years and older. With the company’s next earnings report due on August 5, 2025, investors seeking deeper insights can access comprehensive analysis and 12 additional ProTips through InvestingPro’s detailed research reports, which transform complex financial data into actionable intelligence.
In other recent news, Incyte has announced the FDA approval of Monjuvi in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma. This approval is based on the Phase 3 inMIND trial, which showed significant improvement in progression-free survival. Incyte also presented promising early-stage clinical data for its novel cancer treatment at the European Hematology Association meeting, leading Oppenheimer to maintain its Outperform rating and Jefferies to raise its price target to $82.00. Stifel upgraded Incyte’s rating from Hold to Buy, significantly increasing its price target to $107.00 due to positive trial results for the INCA033989 drug in essential thrombocythemia patients.
Additionally, Specialised Therapeutics has expanded its agreement with Incyte to include two more oncology medicines, axatilimab and retifanlimab, for distribution in Australia, New Zealand, and Singapore. These developments highlight Incyte’s efforts to diversify its product pipeline and expand its market presence. The expanded partnership with Specialised Therapeutics will see Incyte handling the development and manufacturing, while Specialised Therapeutics will manage regulatory approval and distribution. These strategic moves are aimed at securing future revenue streams in the competitive oncology market.
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