Revumenib

Break Through Cancer launches phase 2 trial using revumenib and venetoclax to eliminate minimal residual disease in acute myeloid leukemia, aiming to prevent relapse and improve survival rates.

Syndax Pharmaceuticals, a biotech company focused on cancer therapies, is at a pivotal juncture with recent FDA approvals and upcoming product launches. Key developments include the approval of Niktimvo for cGVHD and the extended PDUFA date for revumenib in AML. The company's financial outlook is stable, with a strong cash position and a cash runway through 2026. Syndax's product pipeline, anchored by Niktimvo and revumenib, shows potential for expansion into new indications like CRC. Analysts maintain a positive outlook, with a consensus price target of $33.00, reflecting optimism about the company's growth trajectory.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.

The FDA extended the PDUFA action date for Syndax Pharmaceuticals' NDA for revumenib, a treatment for relapsed or refractory KMT2Ar acute leukemia, to December 26, 2024, due to a major amendment submission. Revumenib aims to address significant unmet needs in KMT2A-rearranged acute leukemia patients.

Syndax Pharmaceuticals announces FDA Priority Review for revumenib, a menin inhibitor for relapsed/refractory KMT2Ar acute leukemia, with a PDUFA target action date of September 26, 2024, under the FDA's Real-Time Oncology Review Program.