Back to top

Image: Bigstock

Eagle Pharmaceuticals Wraps Up Ryanodex NDA Submission

Read MoreHide Full Article

Eagle Pharmaceuticals, Inc. (EGRX - Free Report) 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 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. , Anika Therapeutics Inc. (ANIK - Free Report) and Sunesis Pharmaceuticals, Inc. . 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 >>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Anika Therapeutics Inc. (ANIK) - free report >>

Eagle Pharmaceuticals, Inc. (EGRX) - free report >>