Research Desk Line-up: Intercept Pharma Post Earnings Coverage
LONDON, UK / ACCESSWIRE / August 8, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Omeros Corp. (NASDAQ: OMER), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=OMER. The Company announced on August 04, 2017, that its lead human monoclonal antibody OMS721 has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy. For immediate access to our complimentary reports, including today's coverage, register for free now at:
Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) for due-diligence and potential coverage as the Company reported on July 31, 2017, its financial results for Q2 2017 which ended on June 30, 2017, and also provided other general business updates. Tune in to our site to register for a free membership, and be among the early birds that get our report on Intercept Pharma 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 OMER; also brushing on ICPT. Go directly to your stock of interest and access today's free coverage at:
Immunoglobulin A nephropathy
OMS721 is Omeros' lead human monoclonal antibody which targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. IgA nephropathy is the most common primary glomerulopathy globally with around 120,000 to 180,000 cases in the US alone. It accounts for 10% of all dialysis patients. In fact, up to 40% of individuals with this disease develop end-stage renal disease, a life-threatening condition, within 20 years after diagnosis.
FDA grants OMS721 breakthrough therapy designation
The Phase-2 clinical trial results with OMS721 in IgA nephropathy patients demonstrate unparalleled decline in urine protein levels during and following treatment with OMS721. Raised urinary protein is highly correlated with poor outcomes in patients with IgA nephropathy. As a consequence to this data review, FDA granted OMS721 breakthrough therapy designation for the treatment of IgA nephropathy in June 2017. The Company aims to commence enrollment of patients in its Phase-3 registration trial in IgA nephropathy towards the end of 2017.
FDA grants OMS721 orphan designation
FDA has granted OMS721 orphan designation with the intention of promoting the development of a drug that is expected to have a noteworthy therapeutic advantage over existing treatments for a condition affecting around 200,000 US patients annually. The orphan designation qualifies the Company for benefits that apply across all stages of drug development, including seven years of market exclusivity following marketing approval, tax credits on US clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
Another Phase-3 program for OMS721 in IgA nephropathy
Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, announced that the Company was working with FDA on initiating another Phase-3 program for OMS721 in IgA nephropathy, which has been granted both breakthrough and orphan designations. This is the second Phase-3 program for OMS721 while the ongoing aHUS program has already received fast track status from FDA. Moreover, he mentioned that a third Phase-3 program for OMS721 could also be added this year in stem cell transplant-associated thrombotic microangiopathy and that, along with aHUS, has been granted orphan designation. Gregory A. Demopulos also expressed that Omeros is focused on bringing OMS721 to market as quickly as possible. He was excited about the benefits that OMS721 is expected to provide for patients across a wide range of serious and life-threatening disorders. As of now, over 150 subjects worldwide have received OMS721 and no safety concerns have been noted yet.
About Omeros' MASP Programs
Omeros owns the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays an important role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. And the MASP-2 is the effector enzyme of the lectin pathway, which is one of the principal complement activation pathways.
Essentially, the inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Its abnormal function is related to a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. However, adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros' lead human MASP-2 antibody.
Omeros sees MASP-3 responsible for the conversion of pro-factor D to factor D and as a critical activator of the human complement system's alternative pathway. The alternative pathway is linked to a range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway. Omeros is also preparing to initiate manufacturing scale-up of its MASP-3 antibodies in advance of clinical trials.
Last Close Stock Review
At the closing bell, on Monday, August 07, 2017, Omeros' stock climbed 1.05%, ending the trading session at $22.15. A total volume of 416.85 thousand shares have exchanged hands. The Company's stock price skyrocketed 43.55% in the last three months, 123.74% in the past six months, and 77.20% in the previous twelve months. Moreover, the stock soared 123.29% since the start of the year. The stock currently has a market cap of $970.81 million.
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 firstname.lastname@example.org. 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.
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/.
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:
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