Incyte Shares Rise on EU Approval for Lymphoma Drug Minjuvi
FDA & Biotech

Incyte Shares Rise on EU Approval for Lymphoma Drug Minjuvi

The European Commission has greenlit the treatment for adult patients with relapsed or refractory follicular lymphoma, a hard-to-treat cancer.

Shares of Incyte Corp. (NASDAQ: INCY) gained ground on Tuesday following the announcement that the European Commission (EC) has granted marketing authorization for its cancer therapy, Minjuvi (tafasitamab).

The biopharmaceutical company’s stock climbed 0.62% to $97.63 in afternoon trading. The Delaware-based firm, which has a market capitalization of approximately $19.05 billion, saw its shares trade near the midpoint of their 52-week range of $53.56 to $109.28.

The approval clears Minjuvi for use in combination with lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma, a form of non-Hodgkin lymphoma. This regulatory milestone is a significant catalyst for Incyte, opening up a new and substantial market for the therapy in the European Union.

Follicular lymphoma is a slow-growing but often incurable blood cancer. For patients whose disease returns after initial treatment or fails to respond to therapy, known as relapsed or refractory cases, treatment options can be limited. The EC's decision provides a new therapeutic option for this difficult-to-treat population.

According to the company's announcement, the approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on the results of a key clinical study that demonstrated the drug's efficacy and safety in this patient group. Minjuvi is a monoclonal antibody that targets the CD19 protein found on the surface of B-cells, which play a central role in several blood cancers.

This European approval represents a crucial step in expanding the commercial footprint of Minjuvi, which was developed in partnership with MorphoSys AG. For Incyte, the approval helps diversify its oncology portfolio, which is currently led by its flagship product Jakafi (ruxolitinib), a treatment for myelofibrosis and other myeloproliferative neoplasms.

While the market awaits further details on the commercial launch and pricing strategy across EU member states, the approval solidifies Minjuvi's role in Incyte's growth trajectory. Wall Street analysts have set an average 12-month price target of $99.62 for the company's stock, suggesting modest upside from its current levels. The successful expansion into the European market for follicular lymphoma will be a key factor for investors tracking the company's performance in the coming quarters.