FDA Approval of Niktimvo
Achieved FDA approval for Niktimvo, the first CSF1R antibody for chronic GVHD, marking a significant milestone in the company's transition to a commercial stage.
Royalty Agreement with Royalty Pharma
Secured a $350 million royalty agreement for Niktimvo, enhancing the company's balance sheet and funding through profitability.
Revumenib Anticipated FDA Approval
Expecting FDA approval for Revumenib in the current quarter, with positive indications for its role in treating KMT2A rearranged acute leukemia.
Strong Financial Position
With $399.6 million in cash and an additional $350 million from the royalty agreement, the company is well-positioned to reach profitability.
Positive Data from Clinical Trials
Updated data from AUGMENT-101 and SAVE trials show promising results for Revumenib, with high overall response rates and potential best-in-class status.