LONDON, UK / ACCESSWIRE / September 27, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for La Jolla Pharmaceutical Co. (NASDAQ: LJPC) ("La Jolla"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=LJPC. The Company announced on September 25, 2017, that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued favorable Scientific Advice for LJPC-501, indicated for the treatment of hypotension in adults with distributive or vasodilatory shock, which remains hypotensive despite fluid and vasopressor therapy. Based on this Advice, La Jolla plans to submit a Marketing Authorization Application (MAA) for LJPC-501 in Q3 2018. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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The Announcement
LJPC-501 is a formulation meant to treat distributive or vasodilatory shock that can turn life-threatening when a patient cannot achieve or maintain mean arterial pressure, even after treatment with fluids and vasopressors. Currently, there are over 500,000 distributive or vasodilatory shock patients in the United States per year where while 200,000 patients failing standard therapy, about 50% of these patients, die within 30 days. Catecholamine resistant hypotension or clinically refractory hypotension (CRH) is a life-threatening syndrome in patients with vasodilatory shock, observed by dangerously low blood pressure with adequate cardiac function.
LJPC-501 is the Company's proprietary formulation of synthetic human angiotensin II which is a major bioactive component of the renin-angiotensin-aldosterone system (RAAS). The system is one of the three central regulators of blood pressure. The Company's portfolio also includes LJPC-30S, a next-generation gentamicin derivative program focused on the potential treatment of bacterial infections and rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy.
The Expanded Access Program
La Jolla announced on August 08, 2017, that it initiated an expanded access program in the United States to deliver its investigational drug, LJPC-501. Expanded access, also known as compassionate use, is an option facilitated by the US FDA to make available prior to regulatory approval investigational medicine for the treatment of serious or life-threatening diseases or conditions where there are limited ongoing clinical trials and currently, there exists a lack of reliable therapeutic alternatives. The Company viewed this announcement as a step to deliver a mechanism for eligible patients to access LJPC-501, while the Company was diligently working to achieve FDA approval.
Company Growth Prospects
On August 28, 2017, the Company announced that the US FDA had accepted for review the Company's New Drug Application for the investigational drug LJPC-501. The review classification for the application was a priority, where the user fee goal date is February 28, 2018.
The New Drug Application was based on the data from the ATHIOS-3 multicenter, randomized, placebo-controlled, double-blind, Phase-3 clinical study of LJPC-501 in patients with the particular disease. The study was executed under a Special Protocol Assessment agreed with the FDA in 2015. A total of 344 patients were randomized, across 9 countries, in the study, where 321 received study treatment and were included in the primary analysis.
Last Close Stock Review
On Tuesday, September 26, 2017, the stock closed the trading session at $34.61, slipping 4.21% from its previous closing price of $36.13. A total volume of 235.18 thousand shares have exchanged hands. La Jolla Pharma's stock price soared 16.97% in the last three months, 1.70% in the past six months, and 34.04% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 97.43%. At Tuesday's closing price, the stock's net capitalization stands at $723.70 million.
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