Kissei Pharmaceutical Submits New Drug Application for Acute Myeloid Leukemia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 27 2026
0mins
Kissei Pharmaceutical announced that the company has submitted a new drug application for manufacturing and marketing approval in Japan for "olutasidenib," indicated for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation. "Olutasidenib was approved in the United States in December 2022 for the treatment of relapsed or refractory AML with a susceptible IDH1 mutation and is sold by Rigel. In Taiwan, our licensee, Orient EuroPharma Co., Ltd. , is developing olutasidenib. Kissei is focused on researching and developing new drugs for rare diseases and conditions that lack sufficient treatments. We are committed to providing new treatment options for patients suffering from these diseases. The impact of this submission on our consolidated financial forecast for the fiscal year ending March 31, 2027, has been incorporated into the forecast disclosed on May 11," the company stated.
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Analyst Views on RIGL
Wall Street analysts forecast RIGL stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 40.255
Low
38.00
Averages
52.00
High
71.00
Current: 40.255
Low
38.00
Averages
52.00
High
71.00
About RIGL
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing therapies for patients with hematologic disorders and cancer. It focuses on products that address signaling pathways that are critical to disease mechanisms. Its products include TAVALISSE, REZLIDHIA, and GAVRETO. TAVALISSE is an oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia. REZLIDHIA is used for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions. It is used for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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See More
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- Industry Experience: Dr. Hannah brings a wealth of experience from the biotechnology sector, having successfully filed over 40 regulatory applications, which will provide valuable guidance for Rigel's clinical strategy and help the company achieve breakthroughs in a competitive market.
See More
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- Safety Warnings: VEPPANU may cause QT interval prolongation, necessitating ECG monitoring before and during treatment, reflecting the company's commitment to patient safety.
- Adverse Reaction Monitoring: Serious adverse reactions occurred in 9% of patients treated with VEPPANU, highlighting the need for vigilance and effective risk management strategies regarding drug side effects.
See More
