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Eagle Pharmaceuticals' Upcoming Catalysts Provide Support For Medium-Term Play


  • Eagle Pharmaceuticals awaits FDA decision for Ryanodex by the end of this month.
  • The company expects another FDA decision for pemetrexed in October.
  • The stock saw a slump following a steep rise earlier this year, providing a good entry point.

By S. Mitra, MBA (ISB)

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) is a specialty pharmaceutical company focused on developing and commercializing injectable products for oncology and critical care segments. The company has a strong portfolio of drugs such as Bendeka and Ryanodex. The company is currently focusing on expanding label indications for its drugs. The stock offers a good short term and medium term opportunity with two FDA decisions coming up in July and October. The company also has solid operational and financial position to support long term value as well.

The company’s upcoming catalyst is in the form of Ryanodex, which is designed for treating External Heat stroke. The FDA is expected to deliver its decision on July 23. Earlier this year, Ryanodex was given the priority review status and thus a shorter review period of six months. Eagle is looking at a potentially lucrative market as there is currently no approved treatment for external heat stroke. The company thus has a strong shot at carving a niche for itself in the market. The treatment is expected to be targeted at athletes and outdoor workers, although it is also going to have more generic applications as well since heat stroke can strike anyone. According to the company’s own estimates, there has been consistent rise in extertional heat related injuries and the annual toll is close to 75,000 cases.

The company’s application has been supported by preclinical data from animal studies and safety and efficacy data from a controlled clinical trial in EHS patients. The drug, used along with body cooling, showed demonstrably better results in treating patients, than body cooling alone. The data shows that the drug has very high chance of getting the FDA approval by the end of this month. Eagle seems to have high expectation of getting the approval as well as the company

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Cautious, low key, disciplined investing in biopharma stocks
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Dr Dutta is a retired veterinary surgeon. He has over 40 years experience in the industry. Dr Maiya is a well-known oncologist who has 30 years in the medical field, including as Medical Director of various healthcare institutions. Both doctors are also avid private investors. They are assisted by a number of finance professionals in developing this service.

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Analyst’s Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in EGRX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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