Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Shares of Ambit Biosciences Corporation (AMBI - Snapshot Report) 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 - Snapshot Report) and AMAG Pharmaceuticals, Inc. (AMAG - Snapshot Report). While Actelion and Vanda carry a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GROUP DXYN 15.84 +7.90%
BOFL HOLDING BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%