Shares of Ambit Biosciences Corporation (AMBI) plummeted 33% to close the trading session on Dec 4, 2013 at $8.56 per share. The plunge followed the disappointing feedback received by the company from the U.S. Food and Drug Administration (FDA) on its oncology candidate quizartinib (AC220).
Ambit Biosciences was hoping to file a new drug application (NDA) to the FDA for quizartinib in the relapsed/refractory acute myeloid leukemia (AML) indication based on data from the phase II and phase IIb studies on the candidate. However, the company’s hopes of seeking accelerated approval based on data from the mid-stage studies were dashed when the U.S. regulatory body asked it to conduct a phase III study on quizartinib before it could file a marketing application.
The FDA stated that it is not in agreement with the fact that that complete remission with incomplete hematologic recovery (CRi) represents a surrogate endpoint that is reasonably likely to predict clinical benefit of the candidate to AML patients. Ambit Biosciences stated that it would comply with the FDA’s instructions and conduct a phase III study on the candidate to asses the overall survival of patients on quizartinib therapy.
Ambit Biosciences is working with the U.S. regulatory body to refine the appropriate starting dose for the proposed phase III study. We expect the necessity of a phase III study to not only push up the research and development costs at Ambit Biosciences but also significantly push back the approval process for quizartinib.
Ambit Biosciences, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space are Actelion Ltd. (ALIOF), Vanda Pharmaceuticals Inc. (VNDA) and AMAG Pharmaceuticals, Inc. (AMAG). While Actelion and Vanda carry a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).
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