Back to top

Analyst Blog

Pharmacyclics, Inc. (PCYC - Analyst Report) submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for its oncology drug, Imbruvica.

Pharmacyclics filed the application on the basis of positive data from a head-to-head phase III study (RESONATE: n=391) on Imbruvica as a monotherapy versus GlaxoSmithKline’s (GSK - Analyst Report) Arzerra (ofatumumab) for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. Pharmacyclics has a partnership on Imbruvica with Janssen (a Johnson & Johnson (JNJ - Analyst Report) company).

According to a planned interim analysis of the randomized, multicenter, open-label study, conducted in Jan 2014, patients treated with Imbruvica as a monotherapy exhibited statistically significant improvement in progression free survival as well as overall survival compared to those treated with Arzerra alone. The drug was found to be safe with a favorable benefit risk profile according to the interim analysis.

We note that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Imbruvica as a monotherapy for the above CLL/SLL indication in Feb 2014. Accelerated approval for the indication was gained on the basis of the overall response rate (ORR) of patients in a phase Ib/II study which did not establish improvements in survival or disease-related symptoms following Imbruvica treatment.

Pharmacyclics also received accelerated approval for Imbruvica as a monotherapy in the mantle cell lymphoma (MCL) indication late last year. Approval was gained for treating MCL patients who have been treated at least once for the disease. Accelerated approval is granted by the FDA to drugs that are meant to treat serious conditions and fulfill an unmet medical need based on a surrogate endpoint. Pharmacyclics is also developing Imbruvica in other oncology indications.

Pharmacyclics, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the same sector is Alkermes (ALKS - Analyst Report). Alkermes holds a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on ALKS
Read the Full Research Report on JNJ
Read the Full Research Report on GSK
Read the Full Research Report on PCYC

Zacks Investment Research

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
QIHOO 360 T… QIHU 95.04 +4.95%
PILGRIMS PR… PPC 31.52 +3.72%
WILLIAMS(C)… CWEI 138.97 +3.55%
FLAMEL TECH… FLML 14.02 +3.16%
CALLON PETE… CPE 11.50 +3.14%