Rigel Pharmaceuticals, Inc. RIGL announced that the FDA has approved Rezlidhia (olutasidenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) in adult patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Per the company, Rezlidhia, an oral inhibitor of mutated IDH1, is developed to bind to and inhibit mIDH1 to lower 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
Shares of Rigel were up 19.8% in after-hours trading on Thursday following the announcement of the news. However, the stock has plunged 74.2% so far this year compared with the industry’s decline of 28.6%.
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The FDA approval for Rezlidhia was based on data from the phase II registrational study, which evaluated Rezlidhia (150 mg) as a monotherapy in mIDH1 R/R AML patients.
In the study, treatment with Rezlidhia demonstrated a complete remission (CR) plus complete remission with a partial hematological recovery (CRh) rate of 35% in mIDH1 R/R AML patients, with a median duration of response of 25.9 months, the primary endpoint.
Out of these patients who achieved the primary endpoint in the above-mentioned registrational study, 92% were in CR with a median duration of response of 28.1 months. Treatment with Rezlidhia was generally well tolerated.
The approval of Rezlidhia is likely to expand Rigel's commercial hematology-oncology portfolio, as the drug provides a new and important treatment option for mIDH1 R/R AML patients who otherwise have a poor clinical outcome.
We note that in August 2022, Rigel entered into an exclusive license agreement with Forma Therapeutics, Inc. [now part of Novo Nordisk NVO] for the development and commercialization of Rezlidhia.
Per the agreement, Rigel will be solely responsible for the commercialization of Rezlidhia in the United States.
We remind investors that NVO completed the acquisition of Forma Therapeutics in October 2022 for approximately $1.1 billion. The acquisition is likely to help Novo Nordisk expand its presence and pipeline in sickle cell disease and other rare blood disorders.
Zacks Rank & Stocks to Consider
Rigel currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited ASLN and Immunocore Holdings plc IMCR, both carrying a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 55.4% for 2022 and 60.6% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
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