Stock Monitor: OptiNose Post Earnings Reporting
LONDON, UK / ACCESSWIRE / May 23, 2018 / If you want access to our free research report on Fibrocell Science, Inc. (NASDAQ: FCSC), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=FCSC as the Company's latest news hit the wire. On May 21, 2018, the Company presented an update on the interim results and progress of its Phase-1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) at the 7th International Investigative Dermatology (IID) meeting held on May 19, 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 OptiNose, Inc. (NASDAQ: OPTN), which also belongs to the Healthcare sector as the Company Fibrocell Science. 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, Fibrocell Science 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:
FCX-007 was Well-Tolerated up to 52 Weeks Post-Administration
The primary objective of open-label, Phase-1/2 clinical trial is to evaluate the safety of FCX-007 in RDEB patients. Additionally, the trial is assessing wound healing and pharmacology at 4, 12, 25 and 52 weeks post-administration. Four adult patients aged 20 to 37 have been dosed with FCX-007 in the margins of and across targeted wounds, as well as in separate intact skin sites. Three patients received a single intradermal injection session at baseline. One patient received a second injection session in the remaining unhealed areas of wounds at 25 weeks post-administration, as allowed by the clinical trial protocol.
Safety data from these patients show FCX-007 was well-tolerated up to 52 weeks post-administration. There were no serious adverse events and no product related adverse events reported. No type VII collagen (COL7) autoantibody response was noted. Various COL7 expression signals were detected throughout the data set using either immunofluorescence (IF) or immunoelectron microscopy (IEM) up to 52 weeks post-administration. Continued positive trends were noted in wound healing and pharmacology signals, including type VII collagen expression and evidence of anchoring fibrils.
Enrollment of Six Patients in Phase-2 Portion of the Trial is Expected to be Completed in Q3 2018
John Maslowski, President and CEO of Fibrocell, said that the Company is pleased with the continued progress of its FCX-007 program that offers promise to be transformative for RDEB patients.
John added that based on safety, pharmacology, and wound healing data, Fibrocell plans to continue exploring dose range and administration for future patients.
The Company reported that one patient has been enrolled in the Phase-2 portion of the trial, with three additional screening visits scheduled prior to the end of June 2018. Enrollment of six patients is expected to be completed in Q3 2018.
About Recessive Dystrophic Epidermolysis bullosa
RDEB is a congenital, progressive, devastatingly painful, and debilitating genetic disorder that often leads to death, and is the most severe form of dystrophic epidermolysis bullosa. RDEB causes severe blistering and areas of missing skin, which is a response to any kind of friction, including normal daily occurrences like rubbing or scratching. Children who inherit the condition are often called "butterfly children" because their skin is as fragile as a butterfly's wings. RDEB patients do not produce functional COL7 due to a mutation in the COL7A1 gene. Collagen 7, a protein, is the main component of anchoring fibrils that hold together the layers of skin. Without these fibrils, skin layers separate causing severe blistering, open wounds and scarring in response to any kind of friction or trauma.
FCX-007 is Fibrocell's clinical-stage, gene therapy product candidate for the treatment of RDEB. FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7 and is being developed in collaboration with Precigen, Inc., a wholly owned subsidiary of Intrexon Corporation. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution.
About Fibrocell Science, Inc.
Founded in 1992 and headquartered in Exton, Pennsylvania, Fibrocell Science is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue.
Stock Performance Snapshot
May 22, 2018 - At Tuesday's closing bell, Fibrocell Science's stock fell 7.34%, ending the trading session at $0.70.
Volume traded for the day: 1.49 million shares, which was above the 3-month average volume of 591.22 thousand shares.
Stock performance in the last month – up 19.36%; previous three-month period – up 7.09%; and year-to-date - up 10.03%
After yesterday's close, Fibrocell Science's market cap was at $23.94 million.
The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry.
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 firstname.lastname@example.org. 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.
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 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:
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.