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Active-Investors: Blog Exposure - FDA Grants Orphan Drug Designation to Avadel Pharma's FT 218 For Treatment Of Narcolepsy

LONDON, UK / ACCESSWIRE / January 12, 2018 / Active-Investors.com has just released a free research report on Avadel Pharma PLC (NASDAQ: AVDL). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/'symbol=AVDL as the Company's latest news hit the wire. On January 10, 2018, the Company, an Irish specialty pharmaceutical organization that develops differentiated pharmaceutical products using its proprietary Micropump® technology, declared that its product FT 218 has been granted the Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of Narcolepsy. Register today and get access to over 1000 Free Research Reports by joining our site below:

www.active-investors.com/registration-sg

Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Avadel Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/'symbol=AVDL

This development was well accepted by investors as share price rose by 8% pre-market on light volume.

About Narcolepsy

Narcolepsy is a chronic brain disorder that affects the brain's ability to control sleep-wake cycles. One of the most prominent symptoms of Narcolepsy is Excessive Daytime Sickness (EDS), which is sudden, irresistible stints of sleep that can occur at any time. These sleep attacks can last a few seconds to several minutes.

Moreover, people with Narcolepsy may have other symptoms like sudden muscle weakness while awake that makes a person go limp or unable to move (i.e. cataplexy), vivid dream-like images or hallucinations, and total paralysis just before falling asleep or just after waking up (i.e. sleep paralysis).

Narcolepsy significantly affects daily activities as people may fall asleep even when they are in the middle of an activity such as driving, eating, or talking. If this condition is not treated timely, it could interfere with psychological, social, and cognitive function development and can inhibit academic, work, and social activities.

About REST-ON Phase-III Clinical Trial

FT 218 is a once-nightly formulation of sodium oxybate, which leverages Avadel Pharma's proprietary Micropump® technology. REST-ON is a double blind, randomized, placebo-controlled Phase-3 study, which intends to evaluate the efficacy and safety of FT 218 for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from Narcolepsy.

The study has enrolled 264 patients so far and is still recruiting. The primary outcome measures for the REST-ON study include longer maintenance wakefulness test (MWT), sleep latency, improvement in CGI sleepiness scores, and fewer cataplexy attacks as recorded by Sleep and Symptom Daily Diary. The Company intends to complete the trial by the end of 2018.

Rationale behind the Orphan Drug Designation

At present, there are limited treatment options for Narcolepsy. In 2002, the FDA approved Xyrem (i.e. sodium oxybate) oral solution for the treatment of Narcolepsy. Post that, it also approved a generic version of Xyrem, developed by Roxane Laboratories in January 2017. Recently, several serious side effects such as seizures, difficulty in breathing, coma, and even death were reported by patients who were administered Xyrem. Besides, sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB), which has previously been used to facilitate sexual assault.

The FDA has granted FT 218 the Orphan Drug Designation on the plausible hypothesis that FT 218 may be clinically superior to Xyrem, owing to the complications associated with the dosing regimen of the previously approved product.

Mike Anderson, the Chief Executive Officer (CEO) at Avadel Pharma, stated that the receipt of the Orphan Drug Designation for FT 218 is an important development for the Company and the patients suffering from Narcolepsy. He believes FT 218 would provide significant benefit to patients and their quality of life over the existing standards of care for this condition.

Implications of the Orphan Drug Designation

The "Orphan Drug Designation' helps advance drug development for rare diseases. The FDA grants the Orphan drug status to only those drugs and biologics that are meant for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the US.

Orphan Designation qualifies the sponsor of the drug for various development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the US after approval. It also facilitates the FDA's assistance in clinical trial design and an exemption from the FDA's user fees.

Stock Performance Snapshot

January 11, 2018 - At Thursday's closing bell, Avadel Pharma's stock climbed 5.27%, ending the trading session at $9.78.

Volume traded for the day: 203.76 thousand shares.

Stock performance in the last month - up 9.27%; and year-to-date - up 19.27%

After yesterday's close, Avadel Pharma's market cap was at $391.80 million.

Price to Earnings (P/E) ratio was at 5.08.

The stock is part of the Healthcare sector, categorized under the Drug Delivery industry. This sector was up 0.5% at the end of the session.

Active-Investors:

Active-Investors (A-I) 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. A-I 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.

A-I has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

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 info@active-investors.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 A-I. A-I 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.

NO WARRANTY

A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

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This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.

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SOURCE: Active-Investors

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