La Jolla Pharmaceutical Company (LJPC - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on Giapreza (angiotensin II) by recommending its marketing application in the drug’s favor to treat refractory hypotension in adult patients with septic or distributive shock.
Giapreza intravenous injection is already marketed in the United States as a vasoconstrictor, indicated to increase blood pressure in adult patients suffering septic or other distributive shock.
This CHMP’s response was based on data from the phase III ATHOS-3 study, which evaluated the safety and efficacy of Giapreza in the given patient population.
Notably, last June, the EMA validated the marketing authorization application (MAA) for Giapreza to treat critically ill patients afflicted with septic or distributive shock and subsequently, started the review process. If approved, Giapreza could be available in the EU market during early 2020 including Iceland, Norway and Liechtenstein.
Shares of La Jolla have dipped 1.9% so far this year against the industry’s rally of 10.9%.
The drug generated sales of $4.4 million, reflecting a skyrocketing surge of 450% year over year in the first quarter of 2019. A potential approval in the EU will surely boost Giapreza’s sales in the future quarters.
Though Giapreza is the sole marketed drug in La Jolla’s portfolio, the company has got some interesting pipeline candidates to boot. LJPC-0118, an investigational product, is being developed for the treatment of severe malaria. The company plans to file a new drug application (NDA) for LJPC-0118 in the fourth quarter of 2019.
Another investigational product, LJPC-401 (synthetic human hepcidin), is being evaluated in a phase II study for the treatment of hereditary hemochromatosis with top-line data expected in the second half of this year. The candidate is also being developed for treating beta thalassemia, sickle cell disease, myelodysplastic syndrome and polycythemia vera.
Zacks Rank & Stocks to Consider
La Jolla currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Assertio Therapeutics, Inc. (ASRT - Free Report) , Soleno Therapeutics, Inc. (SLNO - Free Report) and Evotec AG (EVTCY - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Assertio’s earnings estimates have moved 12.8% north for 2019 and 4.4% for 2020 over the past 60 days.
Soleno’s loss per share estimates have been narrowed 30% for 2019 and 26.1% for 2020 over the past 60 days. The stock has soared 63.7% so far this year.
Evotec’s earnings estimates have been revised 14.4% upward for 2019 and 41.2% for 2020 over the past 60 days. The stock has gained 36.5% year to date.
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