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WILMINGTON, Del. - The U.S. Food and Drug Administration has approved Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), Incyte (NASDAQ:INCY), a $13.2 billion market cap biopharmaceutical company, announced Monday. According to InvestingPro data, Incyte maintains strong financial health with more cash than debt on its balance sheet and has demonstrated robust revenue growth of 17% over the last twelve months.
The approval marks the first FDA-approved therapy combining CD19 and CD20-targeted immunotherapies for this patient population. This is the second approved indication for Monjuvi in the United States. InvestingPro analysis suggests Incyte is currently undervalued, with analysts setting price targets ranging from $52 to $107 per share. The company’s strong liquidity position, with current assets exceeding short-term obligations by 2x, provides a solid foundation for commercializing this expanded indication.
The FDA’s decision was based on results from the Phase 3 inMIND trial, which demonstrated significantly improved progression-free survival (PFS) for patients receiving the Monjuvi combination. Patients in the treatment group achieved a median PFS of 22.4 months compared to 13.9 months in the control arm.
"The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression," said Christina Poh, Assistant Professor of Medicine at the University of Washington.
Serious adverse reactions occurred in 33% of patients who received the Monjuvi combination therapy, with serious infections reported in 24% of patients. The most common adverse reactions included respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, representing up to 30% of NHL cases. While considered an indolent disease, FL is challenging to treat due to frequent relapse and potential transformation into large B-cell lymphoma.
Monjuvi previously received FDA approval in July 2020 for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma in combination with lenalidomide.
According to the press release statement, Incyte offers support programs for eligible patients prescribed Monjuvi through IncyteCARES, providing financial assistance and educational resources. With net income expected to grow this year and a track record of profitable operations, Incyte appears well-positioned to support this commercial launch. For deeper insights into Incyte’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US equities with expert analysis and actionable intelligence.
In other recent news, Incyte Corporation has reported significant developments in its clinical and corporate activities. The company presented promising early-stage clinical data for its novel cancer treatment at the European Hematology Association meeting, showcasing favorable results in patients with essential thrombocythemia. This data has led to positive reactions from analysts, with Oppenheimer reiterating an Outperform rating and Jefferies raising its price target to $82.00. Stifel also upgraded its rating on Incyte from Hold to Buy, significantly increasing its price target to $107.00, citing the drug’s potential in normalizing platelet counts and its promising market prospects.
In terms of partnerships, Incyte expanded its agreement with Specialised Therapeutics to include two additional oncology medicines in Australia, New Zealand, and Singapore. This expansion will see Incyte handling the development and manufacturing, while Specialised Therapeutics will manage regulatory approval and distribution. Additionally, Incyte’s stockholders have approved amendments to its stock incentive and employee stock purchase plans, increasing the available shares and extending the termination date for the stock incentive plan. The election of board members was also confirmed during the Annual Meeting, reflecting continued support for the company’s governance structure.
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