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Pro-Trader Daily: Corporate News Blog - Ionis Submits Marketing Authorization Application to EMA for Inotersen

Research Desk Line-up: Amarin Post Earnings Coverage

LONDON, UK / ACCESSWIRE / November 7, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) ("Ionis"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=IONS. The Company announced on November 03, 2017, the submission of a marketing authorization application (MAA) for Inotersen to the European Medicines Agency (EMA). The submission is based on the Phase-3 NEURO-TTR study in patients with hereditary TTR amyloidosis (hATTR), a severe, rare, and fatal disease in which misfolded protein develop throughout the body creating issues throughout the nervous and cardiac system. For immediate access to our complimentary reports, including today's coverage, register for free now at:

http://protraderdaily.com/register/

Discover more of our free reports coverage from other companies within the Drug Manufacturers-Other industry. Pro-TD has currently selected Amarin Corporation PLC (NASDAQ: AMRN) for due-diligence and potential coverage as the Company announced on November 01, 2017, its financial results for Q3 2017 which ended on September 30, 2017 and also provided an update on company operations. Tune in to our site to register for a free membership, and be among the early birds that get our report on Amarin when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on IONS; also brushing on AMRN. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/'symbol=IONS

http://protraderdaily.com/optin/'symbol=AMRN

The Company noted that Inotersen will be reviewed by the MAA under the EMA's Accelerated Assessment program, which is intended to expedite access to drugs that the EMA considers to be of major therapeutic interest. Ionis believes that the submission to the EMA puts the Company one step closer to its goal of fundamentally changing the treatment landscape for patients and families globally who are facing this devastating, progressive, fatal disease, and for the healthcare professionals who treat them.

About Inotersen

Inotersen is an antisense drug designed to reduce the production of transthyretin (TTR), to treat patients with TTR amyloidosis (ATTR), a progressive and life-threatening disorder. In patients with ATTR, both the mutant and wild-type (wt) TTR builds up as fibrils in tissues, such as the peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid, and bone marrow. The presence of TTR fibrils interferes with the normal functions of these tissues. As the TTR protein fibrils enlarge, more tissue damage occurs and the disease worsens, resulting in a poor quality of life and eventually death.

The US Food and Drug Administration (FDA) has granted the Orphan Drug Designation and Fast Track Status to Inotersen for the treatment of patients with polyneuropathy due to hereditary TTR amyloidosis (hATTR). Inotersen is under regulatory review for marketing authorization in the EU. The EMA has granted the Accelerated Assessment program and the Orphan Drug Designation to Inotersen for the treatment of patients with ATTR. The Company is also planning to submit the NDA to the FDA shortly.

Results Backing Inotersen

Ionis' Inotersen completed a Phase-3 study, NEURO-TTR, in patients with polyneuropathy due to hATTR in May 2017. Results from the study demonstrated benefits compared to placebo across both primary endpoints of the study: the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (QoL-DN), and the modified Neuropathy Impairment Score +7 (mNIS+7), at both eight and 15 months of treatment.

Furthermore, consistent and significant benefits were observed in both the Norfolk-QoL-DN and mNIS+7, independent of disease stage, types of mutation, previous treatment with TTR protein stabilizers, or presence of cardiomyopathy. Inotersen-treated patients benefited significantly in the quality of life primary endpoint compared to placebo, with a difference in magnitude of 11.68 points in the Norfolk QoL-DN score at 15 months of treatment. The Company stated that half of Inotersen-treated patients saw improvement from baseline in the Norfolk QoL-DN score at 15 months of treatment. In addition, clinically meaningful benefits compared to placebo were observed in the SF-36 physical component score, a measure of general health quality of life. Inotersen-treated patients also benefited significantly in the co-primary endpoint of disease control, mNIS+7, with a mean 19.73-point benefit observed after 15 months of treatment compared to placebo-treated patients.

Last Close Stock Review

On Monday, November 06, 2017, the stock closed the trading session at $54.25, slightly advancing 0.17% from its previous closing price of $54.16. A total volume of 1.11 million shares have exchanged hands. Ionis Pharma's stock price skyrocketed 12.30% in the last three months, 15.92% in the past six months, and 99.96% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have surged 13.42%. The stock is trading at a PE ratio of 258.33. At Monday's closing price, the stock's net capitalization stands at $6.73 billion.

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Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

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The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter-holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

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SOURCE: Pro-Trader Daily

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