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Will Positive Regulatory Updates Further Boost INCY Stock?

By Zacks Equity Research | October 20, 2025, 9:30 AM

Incyte INCY has put up a stellar performance year to date on the back of better-than-expected quarterly results, and positive pipeline and regulatory updates.

INCY’s Lead Drug Jakafi Maintains Momentum

Incyte’s lead drug, 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.

Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. Incyte earns royalties from NVS on sales outside the country.

Opzelura Boosts INCY’s Top Line

The FDA’s approval of the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD), under the brand name Opzelura, has been a significant boost for the company. The drug’s label was recently expanded for mild to moderate AD in non-immunocompromised children two years of age and older.

The drug is also approved for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and above. The approval makes Opzelura the first and only topical formulation of a JAK inhibitor approved in the United States. The uptake of Opzelura has been strong, driven by increased patient demand and refills in both atopic dermatitis and vitiligo.

Pipeline/Regulatory Updates Boost INCY Stock

Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.

Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta also contributes to its top-line growth.

The FDA had earlier approved Monjuvi (tafasitamab-cxix) for a new cancer indication.

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

The drug is already approved, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.

Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG in February 2024. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.

The label expansion of the drug should boost sales of the drug.

In May 2025, the FDA approved a label expansion of oncology drug Zynyz (retifanlimab-dlwr), a PD-1 inhibitor. The regulatory body has now approved Zynyz in combination with chemotherapy and as a single agent for the treatment of adult patients with advanced squamous cell carcinoma of the anal canal.

Zynyz is also indicated in the United States for the treatment of adult patients with metastatic or recurrent locally advanced merkel cell carcinoma.

Earlier, INCY’s new global collaboration with Qiagen QGEN also impressed investors.

The collaboration is aimed at developing a novel diagnostic panel to support INCY’s pipeline of investigational treatments for myeloproliferative neoplasms, a group of rare blood cancers.

Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing technology to detect clinically relevant gene alterations in hematological malignancies. QIAGEN will also assist with regulatory submissions and market access efforts in the United States, the EU and certain Asia-Pacific regions.

Our Thoughts on INCY Stock

With a new CEO at the helm, INCY is looking to further diversify and strengthen its portfolio.

Incyte’s recent robust rally is positive, and potential label expansion of existing drugs and the launch of new drugs should generate incremental revenues and drive share price gains.

While Jakafi faces competition from the likes of  GSK plc’s GSK Ojjaara in its approved indications, INCY’s efforts to diversify its portfolio are commendable.

GSK posted strong growth in Ojjaara sales in the first half of 2025, driven by continued uptake in the United States and contributions from Europe and International regions.


 

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This article originally published on Zacks Investment Research (zacks.com).

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