MORGES, Switzerland — Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular...
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WILMINGTON, Del. – Incyte (Nasdaq:INCY) today announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi®) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy...
WILMINGTON, Del. – Incyte (Nasdaq: INCY) today announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). Both the STOP-HS1 and STOP-HS2...
WILMINGTON, Del.- Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The...
WILMINGTON, Del. – Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD). The new...
TOKYO, Japan — Incyte Biosciences Japan G.K. today announced approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today’s approval of Minjuvi in combination with rituximab and lenalidomide marks a...
TOKYO, Japan — Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). “Today’s approval marks a significant milestone for...
WILMINGTON, Del. – Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the...
HOUSTON, TX & SEATTLE, WA — Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma....
HOUSTON, TX & SEATTLE, WA — Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and other immune-mediated diseases, today announced that the U.S. FDA has granted Fast Track designation for its lead clinical program, IDP-023, for the treatment of patients...