Back to top

Analyst Blog

Affymax, Inc. and its partner Takeda Pharmaceutical Company Limited (TKPYY) recently announced that they have recalled all lots of Omontys (peginesatide) voluntarily. The recall was prompted by data from post-marketing studies which revealed that fatal reactions including anaphylaxis were found to be associated with the use of Omontys. The decision is in conformity with the US Food and Drug Administration’s (FDA) views.

A letter to heath care professionals was also issued stating that no patients (new or existing) should be on Omontys. We remind investors that Omontys received approval in the US, in Mar 2012, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The product received approval on the basis of randomized, controlled, open-label, phase III EMERALD studies (EMERALD 1 and 2) which evaluated Omontys in 2,606 patients. At that time, the company reported that the most common side effects associated with Omontys were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication.

However, data from post-marketing studies revealed that hypersensitivity reactions were observed in approximately 0.2% of the patients receiving Omontys and approximately one-third of these patients experienced severe reactions, necessitating immediate medical care and even hospitalization.

The companies noted that approximately 0.02% of patients experienced fatal reactions, till date, after administration of intravenous Omontys. Affymax and Takeda are examining the data. We note that the investors have reacted negatively to the news.

Affymax currently carries a Zacks Rank #4 (Sell), while Takeda Pharma carries a Zacks Rank #3 (Hold). Lannett Company, Inc. (LCI - Snapshot Report) and Cytokinetics, Incorporated (CYTK - Snapshot Report) look more attractive in the pharma sector. Both carry a Zacks Rank #1 (Strong 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

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
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%