Back to top

Analyst Blog

Recently, Celgene Corporation (CELG - Analyst Report) announced that the US Food and Drug Administration (FDA) will review the supplemental New Drug Application (sNDA) for cancer drug Revlimid (lenalidomide) on a priority basis.

Revlimid, the key growth driver at Celgene, is already approved in combination with dexamethasone for treating multiple myeloma (MM) patients who have received at least one prior therapy. Revlimid is also available for treating transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome (MDS) associated with a deletion 5q cytogenetic abnormality (with or without additional cytogenetic irregularities).

Celgene is now looking to get the drug approved for treating patients suffering from relapsed refractory mantle cell lymphoma (MCL). The patients had been previously treated for the disease by drugs including Takeda’s Velcade. The sNDA was filed by Celgene in late 2012 on the basis of encouraging data from a phase II study (EMERGE) which evaluated Revlimid in the indication. A response from the FDA is expected to be out by Jun 5, 2013 (target date).

We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.

Celgene received another good news when the China State Food and Drug Administration cleared Revlimid for the MM indication. The company intends to launch Revlimid for the indication in China in the second quarter of this year. The approval of Revlimid for MM in the high-potential Chinese market should boost the drug’s sales potential significantly.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks, such as Peregrine Pharmaceuticals, Inc. (PPHM - Snapshot Report), Medivation, Inc. (MDVN - Analyst Report) and Targacept, Inc. (TRGT - Snapshot Report) are well placed currently. While Peregrine Pharma and Medivation carry a Zacks Rank #2 (Buy), Targacept carries a Zacks Rank #1 (Strong Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

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 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
UTD THERAPE… UTHR 117.83 +28.51%
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
BANCO DO BR… BDORY 15.53 +3.95%