U.S. Markets closed

Blog Exposure - FDA Accepted for Review Insmed’s Marketing Application for ALIS in NTM Lung Disease Caused by MAC

Stock Monitor: Endocyte Post Earnings Reporting

LONDON, UK / ACCESSWIRE / May 18, 2018 / If you want access to our free research report on Insmed Inc. (NASDAQ: INSM), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=INSM as the Company's latest news hit the wire. On May 16, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA for ALIS to the FDA on March 29, 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:


Active-Investors.com is currently working on the research report for Endocyte, Inc. (NASDAQ: ECYT), which also belongs to the Healthcare sector as the Company Insmed. Do not miss out and become a member today for free to access this upcoming report at:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Insmed 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:


The FDA's Action Date Set in September 2018

The FDA has completed the filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA granted Insmed's request for Priority Review and has set an action date of September 28, 2018, under the Prescription Drug User Fee Act (PDUFA). Priority Review applies to an application for a drug that treats a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness. FDA has previously designated ALIS as an orphan drug, a breakthrough therapy and a Qualified Infectious Disease Product (QIDP).

ALIS has the Potential to be the First Approved Inhaled Therapy for Treatment of NTM Lung Infection in the US

Will Lewis, President and Chief Executive Officer of Insmed, stated that the Company is pleased that the FDA has accepted the NDA with Priority Review, which underscores the urgent need for therapies which address NTM lung disease caused by MAC.

Will added that ALIS has the potential to be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States, and Insmed looks forward to working with the Agency through the review process.

Insmed Extended ALIS Intellectual Property Protection to 2035 with Issuance of 9th US Patent

On February 20, 2018, the United States Patent and Trademark Office (USPTO) issued US Patent Number 9,895,385 concerning methods for treating NTM lung infections, including NTM lung infections caused by MAC, with the Company's ALIS. The claims of the patent relate to methods for treating MAC lung infections via administration of ALIS to non-cystic fibrosis patients by nebulization once daily for a defined treatment period. The patent extended previously existing patent coverage for ALIS by 16 months, from January 2034 into May 2035.

About NTM Lung Disease

NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. There is an increasing prevalence of lung disease caused by NTM. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. Patients with NTM lung disease frequently require lengthy hospital stays to manage their condition. Current guideline-based approaches involve use of multi-drug regimens not approved for the treatment of NTM lung disease, and treatment can be as long as two years or more.

About ALIS

ALIS is a novel, inhaled, once-daily formulation of amikacin that is in late-stage clinical development for adult patients with treatment-refractory NTM lung disease caused by MAC. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function.

Insmed's advanced pulmonary liposome technology uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages where the NTM infection resides. This prolongs the release of amikacin in the lungs while minimizing systemic exposure thereby offering the potential for decreased systemic toxicities. ALIS's ability to deliver high levels of amikacin directly to the lung distinguishes it from intravenous amikacin.

About Insmed Incorporated

Founded in 1999 and headquartered in Bridgewater, New Jersey, Insmed is a global biopharmaceutical company focused on the needs of patients with rare diseases. Insmed is a dynamic and rapidly growing company with a strong pipeline of drug candidates.

Stock Performance Snapshot

May 17, 2018 - At Thursday's closing bell, Insmed's stock was slightly down 0.11%, ending the trading session at $18.51.

Volume traded for the day: 190.99 thousand shares.

Stock performance in the last month – up 2.21%; previous three-month period – up 10.44%; past twelve-month period – up 10.51%; and year-to-date - up 0.05%

After yesterday's close, Insmed's market cap was at $1.83 billion.

Price to Earnings (P/E) ratio was at 10.10.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.1% at the end of the session.


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.


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® charterholder (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.


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.


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/.


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: info@active-investors.com

Phone number: 73 29 92 6381

Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Active-Investors