Incyte received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of its antibody‑drug conjugate Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy. The CHMP recommendation follows the Phase 3 inMIND trial, which showed a median progression‑free survival of 22.4 months versus 13.9 months in the control arm, and a safety profile that aligns with the drug’s established use in the United States.
The inMIND study enrolled 548 adults and confirmed that the combination improved outcomes over standard therapy, with the most common adverse reactions—respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough—remaining manageable. The trial’s results reinforce the therapeutic value of Minjuvi and support the EMA’s recommendation, positioning the drug for a potential launch in the EU market.
Incyte’s U.S. approval of Minjuvi for the same indication already generated strong sales, and the company reported total revenues of $4.813 billion for the twelve months ending September 30, 2025, up 18.09 % year‑over‑year. The company’s Q3 2025 earnings beat expectations, with revenue of $1.37 billion and EPS of $2.26, prompting a raise in full‑year guidance. The positive CHMP opinion is expected to add a substantial new revenue stream, potentially hundreds of millions of dollars, by tapping into the EU follicular lymphoma market, which serves 2‑4 patients per 100,000 people in Western countries.
The EMA’s recommendation is a critical step toward marketing authorization. Once the European Commission adopts the CHMP recommendation, Incyte will be able to file a marketing authorization application, expanding its oncology portfolio and strengthening its competitive position against other follicular lymphoma therapies. The company’s CEO, Bill Meury, highlighted the company’s “strong commercial execution and pipeline prioritization” as key drivers of its recent growth, underscoring confidence in the Minjuvi launch.
Analysts note that the market reaction to the CHMP opinion has been muted, reflecting broader valuation concerns and the company’s ongoing focus on core product growth. Nonetheless, the regulatory approval is a milestone that could accelerate Incyte’s expansion in Europe and enhance its long‑term revenue trajectory.
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