Forma hosted its first Research and Development (R&D) Day.These data were presented at the European Hematology Association (EHA) 2022 Hybrid Congress, the Foundation for Sickle Cell Disease Research (FSCDR) Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, and the Global Congress on Sickle Cell Disease (GCSCD). Presentations included analyses from the Phase I open-label extension study of etavopivat in sickle cell disease indicating that etavopivat decreased the frequency and severity of pain-related adverse events, and the design of the Phase II Gladiolus study of etavopivat in patients with sickle cell disease (SCD) receiving chronic transfusions or transfusion-dependent or non-transfusion-dependent thalassemia. Forma presented new data on the etavopivat clinical development program at multiple hematology conferences.Aspesi brings over 25 years of human resources leadership experience in life sciences and health care services and has a track record of aligning talent plans to company vision and strategy while fostering an equitable and inclusive environment. Linea Aspesi named Senior Vice President, Chief Human Resources Officer.Melián is a physician-scientist with over 20 years of experience developing patient-centric, rare, and orphan disease therapeutics across multiple therapeutic areas, modalities, and phases of development. Agustín Melián, M.D., named Executive Vice President, Head of Research and Development.The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023. Food and Drug Administration (FDA) has accepted Forma’s new drug application (NDA) for olutasidenib.
Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. Olutasidenib is a mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor for the treatment of relapsed or refractory acute myeloid leukemia. to develop, manufacture, and commercialize olutasidenib.