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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Scynexis Inc | NASDAQ:SCYX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.01 | -0.56% | 1.77 | 1.18 | 3.50 | 1.90 | 1.70 | 1.80 | 173,113 | 05:00:09 |
JERSEY CITY, N.J., Jan. 4, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today provided a corporate update, including recent pipeline developments and anticipated milestones in 2018, for its lead antifungal candidate, SCY-078. SCY-078 is the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family in clinical and pre-clinical development for the treatment of several serious fungal infections, including invasive candidiasis, invasive aspergillosis, refractory invasive fungal infections and vulvovaginal candidiasis (VVC).
"In 2017, we made significant progress in advancing the clinical development of SCY-078 in indications addressable and approvable with an orally-administered antifungal therapy," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "In addition, we advanced the IV program of SCY-078 to address the clinical hold placed by the U.S. Food and Drug Administration (FDA) following thrombotic events observed in a Phase 1 study. We plan to restart clinical trials with IV SCY-078 in the third quarter of 2018, using a liposomal IV formulation that has shown an improved tolerability profile in pre-clinical assessments compared with the cyclodextrin-based IV formulation used in the earlier study."
Dr. Taglietti continued: "We are excited about our strategic plans for 2018, when we envision SCY-078 advancing in multiple Phase 2 and Phase 3 trials to maximize the broad potential clinical utility of SCY-078 in addressing unmet medical needs in VVC, invasive candidiasis, invasive aspergillosis and refractory invasive fungal infections."
Path Forward Established for IV Program of SCY-078, with Clinical Trials to Initiate in the Third Quarter of 2018 with an Improved IV Formulation
As previously disclosed in March 2017, the FDA required SCYNEXIS to hold the initiation of any new clinical studies of the IV formulation of SCY-078 following the review of three mild-to-moderate inflammation-related thrombotic events in healthy volunteers receiving the IV formulation at the highest dose level in a Phase 1 study. That study used a cyclodextrin-based IV formulation.
Clinical Development of Oral Formulation of SCY-078 Continues to Progress as Planned in Multiple Indications Approvable with an Oral Agent
SCYNEXIS is pursuing several programs where the oral formulation of SCY-078 has the potential to be a suitable treatment for indications with significant unmet medical needs and considerable commercial potential.
2018 Key Upcoming Milestones
Conference Call Details
SCYNEXIS will host a conference call today at 5:00pm Eastern Time to provide a general corporate and SCY-078 pipeline update, as well as to present its plans for 2018. The call can be accessed by dialing 844-309-3707 or 661-378-9467 prior to the start of the call and referencing conference ID: 2897769. The conference call will also be webcast live over the Internet and can be accessed on the "Investors" section of the SCYNEXIS website, www.scynexis.com.
About SCY-078
SCY-078 is an investigational antifungal agent that is a semi-synthetic derivative of the natural product enfumafungin. SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. SCY-078 is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum of antifungal activity, in vitro and in vivo, against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ:SCYX) is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is a novel IV/oral antifungal agent in Phase 2 clinical and pre-clinical development for the treatment of several serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns regarding the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA's approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
View original content:http://www.prnewswire.com/news-releases/scynexis-provides-corporate-and-scy-078-pipeline-update-300577832.html
SOURCE SCYNEXIS, Inc.
Copyright 2018 PR Newswire
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