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Blog Exposure - Insmed Announced Submission of New Drug to FDA for Patients with Nontuberculous Mycobacterial Lung Disease

Stock Monitor: ARCA biopharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 03, 2018 / Active-Investors.com has just released a free research report on Insmed Inc. (NASDAQ: INSM). 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=INSM as the Company’s latest news hit the wire. On March 29, 2018, the Company announced that it has submitted its New Drug Application (NDA) for Amikacin Liposome Inhalation Suspension (ALIS) to the US Food and Drug Administration (FDA). The submission was made by the Company for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.comis currently working on the research report for ARCA biopharma, Inc. (NASDAQ: ABIO), 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:

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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:

www.active-investors.com/registration-sg/?symbol=INSM

Insmed stated that there are currently no approved therapies in the US to treat this disease. The Company’s submission is supported by its pivotal Phase-3 INS-212 study conducted in subjects with refractory NTM lung disease, the completed Phase-2 study TR02-112, as well as an expanded safety database.

Insmed is anticipating receiving a six-month priority review and that the NDA will be reviewed by the Division of Anti-Infective Products. The FDA will have 60 days to review the submission of the NDA to determine if it is complete and acceptable for filing. The FDA has previously designated ALIS as an orphan drug, a breakthrough therapy and a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.

What is NTM Lung Disease?

NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. Patients with NTM lung disease might 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.

In a decade long study initiated in 1997, researchers found that the prevalence of NTM lung disease in the U.S. was increasing at approximately 8% per year and that NTM patients on Medicare over the age of 65 were 40% more likely to die over the period of the study than those who did not have the disease. In the U.S., Insmed is estimating that there will be between 75,000 and 105,000 patients with diagnosed NTM lung disease in 2018.

About ALIS

ALIS is a novel, inhaled, once-daily formulation of amikacin, which is in late-stage clinical development for adult patients with treatment-refractory NTM lung disease caused by MAC. 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. ALIS is administered once daily using an optimized, investigational eFlow® Nebulizer System.

Study to Support the Claims of ALIS CONVERT (INS-212) and INS-312

CONVERT is a randomized, open-label, global Phase-3 trial designed to confirm the culture conversion results seen in Insmed's Phase-2 clinical trial of ALIS in patients with refractory NTM lung disease caused by MAC. CONVERT is being conducted in 18 countries at more than 125 sites. The primary efficacy endpoint is the proportion of patients who achieve sputum culture conversion by month 6 in the ALIS plus GBT arm compared to the GBT-only arm. Patients who achieve culture conversion by Month 6 will continue in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture. INS-312 is a single-arm, open-label extension study for patients who completed six months of treatment in the INS-212 study but did not demonstrate culture conversion by Month 6. Under the study protocol, patients in the ALIS plus GBT arm of the INS-212 study will receive an additional 12 months of ALIS plus GBT. Patients who crossed over from the GBT-only arm of the INS-212 study will receive 12 months of treatment of ALIS + GBT.

Stock Performance Snapshot

April 02, 2018 - At Monday’s closing bell, Insmed’s stock fell 6.57%, ending the trading session at $21.04.

Volume traded for the day: 1.31 million shares, which was above the 3-month average volume of 886.31 thousand shares.

Stock performance in the past twelve-month period –up 22.54%

After yesterday’s close, Insmed’s market cap was at $1.61 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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