The stock price of Rigel Pharmaceuticals Inc. (NASD: RIGL), which was recently checked, increased 39.89% to $0.9570 during pre-market trading hours on Friday after the business revealed a regulatory approval.
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Which authorization has RIGL declared?
The U.S. Food and Drug Administration (FDA) has authorized REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as identified by an FDA-approved test. This was revealed by Rigel Pharmaceuticals (RIGL) yesterday. A small molecule inhibitor of mutant IDH1 by mouth, REZLIDHIA is intended to bind to and inhibit mIDH1 in order to lower levels of 2-hydroxyglutarate and restore normal cellular differentiation of myeloid cells.
In the context of relapsed/refractory AML, REZLIDHIA is a new, non-intensive monotherapy that has a 35% CR+CRh rate in patients, with over 90% of those responders sustaining full remission. The median duration of CR+CRh is 25.9 months, which is longer than the existing range of treatment alternatives and represents a clinically significant improvement for AML patients. Given the few available therapies for adult patients with mIDH1 R/R AML, who frequently has a dismal prognosis, REZLIDHIA may offer a potent, novel therapy with a well-known safety profile.
Data from the open-label Phase 2 registration research assessing REZLIDHIA monotherapy at a dosage of 150 mg twice daily in 153 mIDH1 R/R AML patients provided support for the FDA clearance. 147 patients with a centrally confirmed IDH1 mutation, who began REZLIDHIA at least six months before the interim analysis cutoff date of June 18, 2021, made up the efficacy-evaluable population. A composite of complete remission (CR) and a full remission with partial hematological recovery served as the study’s main outcome (CRh).
In the research, REZLIDHIA was well tolerated, and the adverse event profile was primarily reminiscent of ailments or symptoms common to AML patients receiving therapy. 16% of individuals had differentiation syndrome, which was often treatable with dosage interruption and corticosteroids. 23% of patients experienced hepatotoxicity, which manifested as an increase in liver function parameters. The majority of these cases could be controlled with dose adjustments.
What has RIGL previously announced?
Rigel Pharmaceuticals (RIGL) and Forma Therapeutics announced their exclusive, global licensing agreement to develop, produce, and market REZLIDHIA in August 2022. According to the terms of the contract, RIGL will be in charge of the launch and marketing of REZLIDHIA in the United States. RIGL also plans to collaborate with possible partners to further develop and market the product abroad.
