We are a biopharmaceutical company focused on the discovery, development and commercialization of drugs to treat unmet medical needs in oncology, autoimmune and inflammatory diseases by inhibiting kinases that are important drivers for those diseases. Our pipeline currently includes three programs, each discovered internally and each aimed at the inhibition of validated kinase targets. Our lead drug candidate, quizartinib, is a once-daily, orally administered FMS-like tyrosine kinase 3, or FLT3, kinase inhibitor. We are planning to initiate a Phase 3 clinical trial in patients with relapsed/refractory acute myeloid leukemia, or AML, who express a genetic mutation in FLT3, in the second quarter of 2014. We believe there is a significant unmet need for more effective treatments of AML, particularly for the subset of patients expressing a genetic mutation in FLT3, known as the FLT3 internal tandem duplication, or FLT3-ITD, mutation. The FLT3-ITD mutation acts like a “power switch” that causes leukemic cells, or blasts, to spread more aggressively and grow back more rapidly following chemotherapy, conferring an especially poor survival outcome. Quizartinib is designed to turn off this switch. Our initial regulatory strategy for quizartinib is focused on relapsed/refractory AML. However, we plan to also develop quizartinib in other AML therapeutic settings, such as a frontline therapy in newly diagnosed AML patients in combination with chemotherapy, followed by continuous quizartinib maintenance therapy including quizartinib maintenance following a hematopoietic stem cell transplant, or HSCT.
Company profile
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
Former names
Aventa Biosciences Corp
SEC CIK
Corporate docs
IRS number
330909648
Latest filings (excl ownership)
15-12B
Securities registration termination
25 Nov 14
EFFECT
Notice of effectiveness
21 Nov 14
POS AM
Prospectus update (post-effective amendment)
20 Nov 14
S-8 POS
Registration of securities for employees (post-effective amendment)
20 Nov 14
S-8 POS
Registration of securities for employees (post-effective amendment)
20 Nov 14
8-K
Completion of Acquisition or Disposition of Assets
17 Nov 14
SC 14D9/A
Tender offer solicitation (amended)
13 Nov 14
25-NSE
Exchange delisting
12 Nov 14
SC TO-T/A
Third party tender offer statement (amended)
12 Nov 14
SC 14D9/A
Tender offer solicitation (amended)
29 Oct 14
Latest ownership filings
SC 13G/A
Ambit Biosciences Corp
10 Dec 14
SC 13D/A
Ambit Biosciences Corp
19 Nov 14
SC 13G
Ambit Biosciences Corp
24 Oct 14
SC 13G/A
Ambit Biosciences Corp
9 Sep 14
SC 13G
Ambit Biosciences Corp
7 Jul 14
SC 13D
Beneficial ownership report
19 Mar 14
SC 13G
Ambit Biosciences Corp
14 Feb 14
SC 13G/A
Ambit Biosciences Corp
14 Feb 14
SC 13G/A
Ambit Biosciences Corp
14 Feb 14
SC 13G
Ambit Biosciences Corp
13 Feb 14