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Novartis Offers Positive Data on Breast Cancer Drug LEE011

Shares of Novartis AGNVS gained 3.2% after the company announced encouraging data from a phase III study, MONALEESA-2, on its breast cancer candidate, LEE011(ribociclib).

A look at Novartis' year-to-date share price movement shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. It has lost 18.9% so far this year, which compares unfavorably with the 7% fall for the industry.

Coming back to the latest news, MONALEESA-2 evaluated the safety and efficacy of LEE011, a CDK4/6 inhibitor, in combination with letrozole, compared to letrozole alone, in postmenopausal women who have received no prior therapy for hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

Data from the study demonstrated that LEE011 plus letrozole significantly prolonged progression-free survival (PFS) across pre-planned patient subgroups. The strength of LEE011, in combination with letrozole, in the first-line setting showed that treatment benefit was evident across all patient subgroups regardless of their disease burden or tumor location, including patients with aggressive disease.

Currently, Novartis is evaluating the secondary endpoints, including overall survival in the study.

We note that in Oct 2016, the FDA accepted a New Drug Application (NDA) for LEE011 and granted Priority Review as the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, in combination with letrozole. In August, the candidate had received Breakthrough Therapy designation in the U.S.

Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Gleevec in recent times. Additionally, its oncology drugs are facing competition from immuno-oncology therapies.

NOVARTIS AG-ADR Price and Consensus

NOVARTIS AG-ADR Price and Consensus | NOVARTIS AG-ADR Quote

Novartis currently has Zacks Rank #4 (Sell).

Key Picks in the Sector

Some better-ranked stocks in the health care sector include Heska Corp. HSKA , Sucampo Pharmaceuticals, Inc. SCMP and Cambrex Corp. CBM . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sucampo's earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $158 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Heska's earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 76.5% year to date.

Cambrex's earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 11.5% year to date.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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