The Rigel Pharmaceuticals Inc (NASDAQ: RIGL) stock price soared 40.5% after the US Food and Drug Administration (FDA) approved its leukemia drug known as REZLIDHIA™ (olutasidenib).
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The drug is administered via capsules to adults suffering from relapsed or refractory (R/R) acute myeloid leukemia (AML). The target patients have a susceptible isocitrate dehydrogenase-1 (IDH1) mutation detected by an FDA-approved test.
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Investors cheered the development, which now paves the way for the firm to start marketing its newly-approved drugs and generating revenues from the same. Some analysts are calling for Rigel Pharma to be acquired by a larger pharmaceutical company.
The FDA’s approval came after Rigel Pharma provided data from its open-label phase 2 registrational study evaluating REZLIDHIA monotherapy. Patients with 153 mIDH1 R/R AML were given 150 mg twice daily.
The study was conducted on 147 patients with a centrally confirmed IDH1 mutation who started taking REZLIDHIA at least six months before the interim analysis cutoff date of June 18, 2021. The trial met its primary endpoint of a combination of complete remission (CR) plus complete remission with partial hematological recovery (CRh).
CRh can be described as less than 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts. The trial results indicated a 35% (51/147) CR+CRh rate in mIDH1 R/R AML patients, with a median response duration of 25.9 months.
Raul Rodriguez, Rigel's president and CEO, said: We are delighted by the approval of REZLIDHIA based on the strength of data supporting the efficacy and safety of the product. REZLIDHIA provides a new and important, oral therapy option for patients who typically have a poor clinical outcome. Additionally, this approval greatly strengthens and expands Rigel's commercial hematology-oncology portfolio. I would like to extend our sincerest thanks to all the patients, their families and caregivers, the doctors, the FDA, and our team members who have all contributed to the approval of REZLIDHIA.”
*This is not investment advice.
Rigel Pharma (RIGL) stock price.
The Rigel Pharmaceuticals stock price rallied $40.48% to trade at $0.96, rising from Friday’s closing price of $0.68.
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