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137 articles with SCYNEXIS, Inc.
As of September 30, 2018, SCYNEXIS has $49.5 million in cash and cash equivalents and short-term investments, adequate to fund activities into 2020.
SCYNEXIS Announces FDA Agreement with Company-Proposed Phase 3 Vulvovaginal Candidiasis Program for Oral Ibrexafungerp
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced the successful completion of an End-of-Phase 2 Meeting with the Food and Drug Administration (FDA) for its lead product candidate, ibrexafungerp (formerly SCY-078), for patients with vulvovaginal candidiasis (VVC).
SCYNEXIS, Inc. Announces First Patient Dosed in Phase 3 Open-label Study Evaluating Oral Ibrexafungerp in Candida auris Infections (CARES)
Ibrexafungerp's potent activity against multidrug-resistant fungal pathogen Candida auris confirmed in multiple pre-clinical studies
HHS and CDC Lead Efforts Aim to Combat Antimicrobial Resistance, Raise Awareness of Fungal Diseases
SCYNEXIS, Inc. today announced that the Company will present at the following upcoming investor conferences
SCYNEXIS, Inc. announced that the Company will participate in the following upcoming investor conferences:
8/27/2018Who made a splash in the biotech world this week? Here are some notable people.
Oral dose regimen of ibrexafungerp (formerly SCY-078) identified for Phase 3 VVC development; Phase 3 on track for initiation in the fourth quarter of 2018
Arc Bio launched its proprietary antimicrobial resistance (AMR) software. It is the first in what it expects to be a series of next-generation sequencing (NGS)-based products for pathogen detection.
The World Health Organization Recognizes New Antifungal Class by Granting "ibrexafungerp" to SCYNEXIS as the International Non-Proprietary Name for SCY-078
New WHO INN stem "-fungerp" signifies a novel class of antifungals Novel generic name highlights the unique attributes of SCY-078 and its potential to address significant unmet needs across multiple indications
SCYNEXIS Reports Positive Results from Phase 2b Dose-Finding Study of Oral SCY-078 in Vulvovaginal Candidiasis
Clinically and mycologically effective and well-tolerated oral dose of SCY-078 identified for use in Phase 3 registration program.
FDA’s Approval of T2 Biosystems T2Bacteria Panel Underlines Importance of Sepsis Diagnosis and Tr...
7/10/2018On May 29, the FDA cleared T2 Biosystems’ T2Bacteria Panel for diagnosis of sepsis. In that sepsis is the third-leading cause of death in the U.S., this emphasizes the importance of work in this area.
20th International Symposium on Infections in the Immunocompromised Host (ICHS)
SCYNEXIS, Inc. announced the presentation of data at American Society for Microbiology (ASM) Microbe 2018
SCYNEXIS Announces the Publication of Phase 1 Study Results for SCY-078 in The Journal of Clinical Pharmacology
New study results demonstrate low risk of interactions between SCY-078 and drugs metabolized by CYP enzymes
SCYNEXIS, Inc. today announced that Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, will participate in a panel at the 2018 BIO International Conference at the Boston Convention and Exhibition Center on Wednesday, June 6, 2018 from 4:15 - 5:15 p.m. ET.
Enrollment complete in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018
On May 1, the U.S. Food and Drug Administration (FDA) granted Scynexi’s oral formulation of SCY-078 to treat vulvovaginal candidiasis (VVC) and recurrent VVC both Qualified Infectious Diseases Product (QIDP) and Fast Track Designation.
SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC
QIDP provides five additional years of market exclusivity, and Fast Track expedites the regulatory path Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018 Initiation of Phase 3 registration program in VVC planned for the fourth quarter of 2018, with potential NDA filing in 2020
SCYNEXIS Data Presentations at ECCMID 2018 Show SCY-078 Potent and Synergistic Antifungal Activity Against Aspergillus and Pneumocystis
SCYNEXIS, Inc. announced data presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 21-24, 2018, in Madrid, Spain.