Aptose Biosciences Inc (APTO)

[dcaf7]

Just came across the news that a Flt3 inhibitor, Quizartinib is under priority review with a PDUFA date as of April 24, 2023. The NDA is for quizartinib “in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia (AML)”.
Checked a history of the drug. It was co-developed by Astellas and Ambit Biosciences. In 2013, Astellas ended collaboration. In 2014, Daiichi acquired Ambit for $315 million in cash plus $95 million in CVRs. Quizartinib was the main asset of the company. It was demonstrated that with Quizartinib, 50% of relapsed AML patients experienced composite complete response.
In 2018, Daiichi received a BTD and submitted an NDA for Quizartinib as a treatment of adult patients with relapsed/refractory FLT3-ITD AML. In 2019, they received a CRL. In 2022, Daiichi submitted an NDA for Quizartinib plus chemotherapy for patients with newly diagnosed AML who are Flt3-ITD positive.
Point is that with good results in Flt3-mut inhibitor failures, Aptose could be considered as an acquisition target and a price tag north of $400M looks as reasonable.