Rigel bets $230M that Forma's leukemia drug gets in formation with FDA

Rigel Pharmaceuticals has handed over $2 million in cash for exclusive licensing rights to Forma Therapeutics’ olutasidenib, an oncology treatment that currently awaits an FDA approval decision.

As part of the agreement, Californian biotech Rigel will handle the potential launch and commercialization of Forma’s treatment for relapsed/refractory acute myeloid leukemia, a quickly progressing cancer of the bone marrow and blood. Forma could make up to $17.5 million if certain regulatory, approval and initial commercial sales milestones are hit, plus future development and commercial milestone payments of $215.5 million and tiered royalties.

The oral small molecule inhibits mutant isocitrate dehydrogenase-1 and has shown efficacy, duration of response and a favorable tolerability profile in a phase 2 trial, Jorge Cortes, M.D., director of the Georgia Cancer Center and trial investigator, said in an Aug. 2 release. 

However, the drug still has to make it past the FDA’s gates. The agency has already accepted Forma’s new drug application and will get back to the biotechs with an official decision by Feb. 15, 2023.

If approved, olutasidenib would be Rigel’s second commercial product in the hematology-oncology sector, second to Tavalisse for adults with low platelet counts due to chronic immune thrombocytopenia.

Forma, for its part, was a Fierce 15 winner in 2011, chosen as one of the most innovative private biotechs for the year. Since then, the Massachusetts biotech debuted on the market with an upsized $278 million IPO in 2020. Helmed by Genentech veteran Frank Lee, the biotech’s near future is centered around etavopivat, its investigational selective pyruvate kinase-R activator for people with sickle cell disease, thalassemia and lower risk myelodysplastic syndromes.