Markets

Eagle Pharmaceuticals Wraps Up Ryanodex NDA Submission

Eagle Pharmaceuticals, Inc.EGRX announced that it has completed the submission of its 505(b)(2) New Drug Application (NDA) in the U.S. for Ryanodex. The company is looking to get Ryanodex approved for the treatment of exertional heat stroke (EHS).

A look at Eagle Pharma's price movement shows that the company has outperformed the Medical-Products industry in the past one year. The stock decreased 9.2% during this period, compared with the industry's 4% drop.

Coming back to the latest news, Eagle Pharma has requested for Priority Review. If granted, the company expects a decision from the FDA in Jul 2017; otherwise the approval is anticipated later in 2017.

In the U.S., Ryanodex enjoys both Orphan Drug and Fast Track designations for the treatment of EHS.

Notably, the market for EHS holds a high unmet need with no currently approved treatments for this indication. A successful development of the product will hence be a significant boost for the company.

We remind investors that Ryanodex is currently approved in the U.S. for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

Meanwhile, Eagle Pharma continues to progress with other pipeline candidates. Earlier this month, the company completed the submission of a 505(b)(2) NDA for pemetrexed. The company is seeking approval of its ready-to-dilute (RTD) pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer, and mesothelioma (in combination with cisplatin).

Going forward, we expect investor focus to remain on the regulatory status of Ryanodex and pemetrexed.

Eagle Pharmaceuticals, Inc. Price and Consensus

Eagle Pharmaceuticals, Inc. Price and Consensus | Eagle Pharmaceuticals, Inc. Quote

Eagle Pharma currently carries a Zacks Rank #5 (Strong Sell).

Key Picks in the Sector

Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP , Anika Therapeutics Inc. ANIK and Sunesis Pharmaceuticals, Inc. SNSS . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sucmapo's earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 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 35.5%.

Anika's earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 37.8%.

Sunesis' loss estimates narrowed 5.06% and 8.80% for 2017 and 2018, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

Zacks' Top 10 Stocks for 2017

In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?

Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Anika Therapeutics Inc. (ANIK): Free Stock Analysis Report

Sucampo Pharmaceuticals, Inc. (SCMP): Free Stock Analysis Report

Eagle Pharmaceuticals, Inc. (EGRX): Free Stock Analysis Report

Sunesis Pharmaceuticals, Inc. (SNSS): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

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.

In This Story

EGRX ANIK SNSS

Other Topics

Stocks

Latest Markets Videos

    Zacks

    Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at www.zacks.com.

    Learn More