RIGL News & Events

Rigel Pharmaceuticals announced the closing of its license agreement for VEPPANU, or vepdegestrant, following the early termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976 and satisfaction of other customary closing conditions. Rigel previously announced it entered into an exclusive, global license agreement with Arvinas (ARVN) and Pfizer (PFE) to develop, manufacture and commercialize VEPPANU. VEPPANU is approved by the FDA for the treatment of adults with estrogen receptor-positive/human epidermal growth factor receptor 2-negative-estrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The agreement is effective as of June 11 and Rigel has made the upfront payment of $70.0M to be distributed evenly between Arvinas and Pfizer, consistent with the terms of the agreement. Rigel expects to make VEPPANU commercially available in August.

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.

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.