LONDON, UK / ACCESSWIRE / September 27, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for Aradigm Corp. (NASDAQ: ARDM), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=ARDM. The emerging specialty pharmaceutical Company announced on September 25, 2017, that the US Food and Drug Administration (FDA) has approved its Priority Review Status filing for its New Drug Application (NDA) for Linhaliq. Linhaliq has been specifically designed for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic infections with Pseudomonas aeruginosa (P. aeruginosa). For immediate access to our complimentary reports, including today's coverage, register for free now at:
http://protraderdaily.com/register/
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 ARDM. Go directly to your stock of interest and access today's free coverage at:
http://protraderdaily.com/optin/'symbol=ARDM
About Linhaliq
Linhaliq is an investigational proprietary formulation of ciprofloxacin for inhalation, meant for the treatment of NCFBE. Previously, it was known as Pulmaquin®; it is made of a mixture of liposome encapsulated and unencapsulated ciprofloxacin.
Ciprofloxacin, which is available in oral and intravenous formulations, is a commonly prescribed antibiotic. Mostly, it is used to treat acute lung infections due to its broad-spectrum antibacterial activity against different bacteria such as P. aeruginosa. As of now, no treatments have been approved for NCFBE patients to prevent or ease the number of pulmonary exacerbations (PEs). As of now, the Company has concluded two Phase-3 clinical trials with Linhaliq.
What does the Priority Review Status Imply?
- The Priority Review Status for the Linhaliq NDA is important as it would fast-track the timing of the FDA review of the application compared to a standard review.
- The Prescription Drug User Fee Act (i.e. PDUFA) goal date for accomplishment of the FDA review of the Linhaliq NDA is January 26, 2018.
Non-Cystic Fibrosis Bronchiectasis, a Chronic Lung Infection
Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic, and rare disease, mostly associated with chronic lung infections. It is basically characterized by abnormal dilatation of the bronchi and bronchioles. Often, it is an outcome of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage.
An unmet medical need
It has been noted that NCFBE patients who have chronic infections with P. aeruginosa have a 6.5-fold increase in hospitalization, three times greater mortality, and an inferior quality of life, in comparison to those without P. aeruginosa infections.
The infection affects over 150,000 people in the US and more than 200,000 people in Europe. But as of now, there is no drug approved for the treatment of this condition. Thus, it signifies an unmet medical need with high morbidity and mortality.
Aradigm Pleased with the Priority Status
Dr. Igor Gonda, Chief Executive Officer at Aradigm Corporation, expressed his contentment with FDA's acceptance of their NDA filing with Priority Review. He mentioned that the Company looks forward to collaborating with the FDA throughout the review process to facilitate the approval of Linhaliq. He believes Linhaliq would provide the desired treatment for NCFBE patients suffering with chronic lung infection with P. aeruginosa.
Other FDA Approvals for Aradigm Drugs
- Aradigm obtained the Orphan Drug Designation status for its liposomal ciprofloxacin for inhalation for the management of bronchiectasis, whereas for Linhaliq for the management of bronchiectasis.
- Apart from that, the Company received a Qualified Infectious Disease Product (QIDP) designation for the treatment non-cystic fibrosis bronchiectasis patients who have chronic lung infections with P. aeruginosa. Subsequently, it was also granted Fast Track Designation for the same.
About Aradigm
Aradigm works towards the development as well as commercialization of drugs meant for the prevention and treatment of severe respiratory diseases.
Last Close Stock Review
On Tuesday, September 26, 2017, the stock closed the trading session at $3.60, jumping 7.14% from its previous closing price of $3.36. A total volume of 2.04 million shares have exchanged hands, which was higher than the 3-month average volume of 230.96 thousand shares. Aradigm's stock price skyrocketed 188.00% in the last one month, 168.66% in the past three months, and 118.18% in the previous six months. Furthermore, since the start of the year, shares of the Company have soared 125.00%. The stock currently has a market cap of $42.12 million.
Pro-Trader Daily:
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.
PRO-TD 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 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.
NO WARRANTY
PRO-TD, 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. PRO-TD, 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, PRO-TD, 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.
NOT AN OFFERING
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 PRO-TD 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://protraderdaily.com/disclaimer/.
CONTACT
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Email: contact@protraderdaily.com
Phone number: (917) 341.4653
Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.
SOURCE: Pro-Trader Daily
