Back to top

Analyst Blog

Swiss pharmaceutical giant Novartis (NVS - Analyst Report) recently announced mixed data from a phase III study of its acute heart failure (AHF) candidate RLX030 (serelaxin).

The study met one of its two primary objectives of reducing dyspnea (shortness of breath) in patients suffering from AHF. Novartis also reported that RLX030 lessened all-cause and cardiovascular mortality rate by 37% in patients suffering from AHF compared to placebo after six months.

The phase III study, however, failed to meet its secondary objectives of days alive and out of hospital and cardiovascular death or re-hospitalization due to heart or kidney failure up to day 60. The second co-primary endpoint was also not achieved.

Novartis is discussing the phase III results with regulatory authorities around the globe. The company, along with its wholly owned subsidiary Corthera Inc., has worldwide rights to RLX030 (except in Canada).

Given the mixed data on the candidate, the company could be required to conduct an additional study depending on the label.

We note that Novartis has several candidates under development for the treatment of heart failure. In August this year, the company announced positive results from a phase II study of LCZ696, which showed significant reduction in a key indicator of morbidity and mortality in patients suffering from chronic heart failure with preserved ejection fraction (HF-PEF). The heart failure market currently has players like Takeda Pharmaceutical Company Limited (TKPYY) and Merck & Co (MRK - Analyst Report).

Novartis also received encouraging news on its Cushing's disease candidate Signifor (pasireotide). The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) provided a positive opinion on the candidate to treat patients suffering from Cushing's disease and who required medical therapeutic intervention.

The advisory panel’s support for the candidate was based on positive data from the phase III PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) study on Signifor.

We remind investors that in April this year, Signifor was approved in the EU for the treatment of Cushing's disease.

Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.

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
CHINA BIOLO… CBPO 56.96 +2.50%
AROTECH COR… ARTX 3.74 +1.77%
BANCO DO BR… BDORY 14.18 +1.65%
GTT COMMUNI… GTT 12.18 +1.58%
CHYRONHEGO… CHYR 2.59 +1.57%