RIGL News & Events

H.C. Wainwright analyst Joseph Pantginis notes that this morning, Rigel partner Kissei Pharmaceutical announced that it submitted an NDA in Japan for Rezlidhia, or olutasidenib, for the treatment of relapsed/refractory AML with a susceptible IDH1 mutation. The firm views this filing as a positive regulatory step under the September 2024 Kissei partnership, which gave Kissei exclusive development and commercialization rights for olutasidenib in Japan, South Korea, and Taiwan. Under the agreement, Rigel received a $10M upfront payment and is eligible for up to $152.5M in development, regulatory, and commercial milestones, along with tiered product transfer-price payments in the mid-20% to low-30% range based on net sales. Wainwright is pleased with this update as Rezlidhia's ex-U.S. reach broadens. The firm has a Buy rating on Rigel with a price target of $57 on the shares.

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.