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SCYNEXIS, Inc. (SCYX)

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6.97-0.08 (-1.13%)
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Neutralpattern detected
Previous Close7.05
Open7.01
Bid6.30 x 800
Ask8.20 x 900
Day's Range6.72 - 7.01
52 Week Range5.00 - 14.40
Volume42,124
Avg. Volume138,085
Market Cap68.872M
Beta (5Y Monthly)1.69
PE Ratio (TTM)N/A
EPS (TTM)-5.55
Earnings DateMay 11, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est47.86
  • GlobeNewswire

    SCYNEXIS Reports Successful Completion of Pre-NDA Meetings with the FDA Regarding Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis

    * Following recent productive meetings, the Company remains on track to submit a New Drug Application (NDA) for the treatment of Vulvovaginal Candidiasis (VVC), also known as Vaginal Yeast Infection, in Q4 2020.JERSEY CITY, N.J., July 29, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, today announced the successful completion of pre-NDA meetings with U.S. Food and Drug Administration (FDA) regarding ibrexafungerp for the treatment of VVC, a common fungal infection that affects millions of women in the U.S. every year.The purpose of the meetings was to discuss and confirm the clinical, non-clinical and chemistry, manufacturing and controls (CMC) content and requirements for the Company’s planned NDA submission and ensure that all elements of submission are met. Ahead of the meetings, SCYNEXIS submitted a pre-NDA briefing document to the FDA that outlined the Company’s preliminary data package, including clinical safety and efficacy, non-clinical results, CMC and other regulatory elements. Based on FDA feedback, the Company believes its regulatory package will be sufficient to support a submission of ibrexafungerp for the treatment of VVC. The Company remains on track to submit its NDA in Q4 2020.“We are extremely encouraged by our collaborative meetings with the Agency,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “This is an important milestone for us as we advance what could potentially be the first new antifungal class to be approved in over 20 years, and the only oral, non-azole treatment option for women suffering from vaginal yeast infections.”SCYNEXIS previously announced positive top-line results from its Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306) investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with VVC. In both studies, ibrexafungerp consistently showed statistical superiority over placebo for the key endpoints required to support the NDA filing for this indication. Additionally, ibrexafungerp had a favorable tolerability profile throughout its Phase 3 program in VVC. Enrollment is ongoing in the Phase 3 CANDLE study, investigating the safety and efficacy of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. Pending successful completion of this trial, SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for this indication in the second half of 2021.About IbrexafungerpIbrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and 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 oral and intravenous (IV) formulations. Ibrexafungerp 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 antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.About SCYNEXISSCYNEXIS, 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 developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, having discovered and developed more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in Phase 3 clinical and preclinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.Forward Looking StatementStatements contained in this press release regarding expected future events or results are "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's ability to submit an NDA to the FDA as scheduled and to obtain FDA approval for ibrexafungerp. These and other risks are described more fully in SCYNEXIS's 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 Irina Koffler LifeSci Advisors Tel: (646) 970-4681 ikoffler@lifesciadvisors.comMedia Relations Gloria Gasaatura LifeSci Communications Tel: (646) 970-4688 ggasaatura@lifescicomms.com

  • SCYNEXIS, Inc.'s (NASDAQ:SCYX) Shift From Loss To Profit
    Simply Wall St.

    SCYNEXIS, Inc.'s (NASDAQ:SCYX) Shift From Loss To Profit

    SCYNEXIS, Inc.'s (NASDAQ:SCYX): SCYNEXIS, Inc., a biotechnology company, delivers therapies for the treatment fungal...

  • GlobeNewswire

    SCYNEXIS Announces Four Posters Presented at ASM Microbe 2020 Highlighting the Potential Clinical Utility of Ibrexafungerp

    Clinical and preclinical studies demonstrate ibrexafungerp’s broad-spectrum activity and potential to treat a range of serious and life-threatening fungal infectionsJERSEY CITY, N.J., July 22, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of four posters at the American Society for Microbiology (ASM) Microbe 2020 held virtually from June through August. The posters, presented as part of the ASM Microbe Online 2020 Summer of Science program, now available online, highlight the potential clinical utility of ibrexafungerp. Ibrexafungerp is the first representative of a new class of antifungal agents called triterpenoids, which are broad-spectrum, fungicidal, and designated by the suffix “-fungerp”. Following the successful completion of its VANISH Phase 3 program, the Company plans to submit a new drug application (NDA) for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, while advancing several late-stage programs for the treatment of life-threatening fungal infections in hospitalized patients. “Fungal infections are increasingly common and often represent serious public health threats, yet there are limited treatment options. The clinical and preclinical studies presented at ASM Microbe 2020 highlight ibrexafungerp’s potential across a broad spectrum of fungal infections, including resistant strains,” said Marco Taglietti, M.D., Chief Executive Officer of SCYNEXIS. “As superbugs flourish and antifungal drug development dwindles, we remain committed to advancing ibrexafungerp, our novel antifungal, for patients in the hospital and community settings. The COVID-19 pandemic is a powerful reminder about the importance of continuous development of anti-infectives.”Poster Details:TitleTreatment Outcomes of Oral Ibrexafungerp in Patients with Severe Fungal Infections, Refractory to or Intolerant of Standard of Care Antifungals: Results from the Phase 3 FURI Study Second Interim Analysis SessionVirtual 380 - CIV01 Clinical Studies of Adult Infectious Diseases including Epidemiology and Clinical Trials AuthorsN. Azie, D. Angulo HighlightsAn interim analysis of 21 patients from the Phase 3 clinical study evaluating ibrexafungerp for the treatment of patients intolerant to the standard of care treatment for Candida infections (FURI Study) found that treatment with oral ibrexafungerp showed significant clinical benefit in 81% of patients, with 12 (57%) patients achieving a complete or partial response and 5 (24%) patients with stable disease. [Link to study details] TitleDelayed Initiation of the Novel Glucan Synthase Inhibitor, Ibrexafungerp, is Effective in a Murine Model of Invasive Candidiasis Caused by Candida Auris SessionVirtual 320 - AAR03 Antifungal Resistance Epidemiology and Mechanisms AuthorsN. P. Wiederhold1, L. K. Najvar1, R. Jaramillo1, M. Olivo1, H. P. Patterson1, S. Barat2, K. Borroto-Esoda2, G. Catano1, T. F. Patterson1; 1UT Hlth.San Antonio, San Antonio, TX, 2SCYNEXIS, Inc., Jersey City, NJ HighlightsAn in vivo delayed initiation study of Candida auris in a murine model found that treatment with ibrexafungerp (40mg/kg) significantly improved survival and reduced fungal burden. These data further support the potential utility of ibrexafungerp as a treatment for invasive infections caused by Candida auris. [Link to study details] TitleDetermination of Antifungal Activity of SCY-078, a Novel Glucan Synthase Inhibitor, against a Broad Panel of Rare Pathogenic Fungi SessionAAR03 Antifungal Resistance Epidemiology and Mechanisms AuthorsM. Ghannoum1, L. Long1, R. Sherif1, F. Z. Abidi1, K. Borroto-Esoda2, S. Barat2, D. Angulo3, N. Wiederhold4; 1Case Western Reserve Univ., Cleveland, OH, 2Scynexis, Inc., Jersey City, NJ, 3Scynexis, Jersey City, NJ, 4Univ. of Texas San Antonio, San Antonio, TX HighlightsAn in vitro study found that ibrexafungerp demonstrated potent activity against 13 different genera of rare fungal pathogens and effectiveness against 7 more, supporting its broad-spectrum activity and potential to treat a range of fungal pathogens. [Link to study details] TitleIbrexafungerp or Caspofungin in Combination with Azoles against Clinical Isolates of Aspergillus, Including Those Resistant to Azoles SessionVirtual 335 - AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/Pre-phase 2) - In vitro and In vivo study of new antimicrobials AuthorsV. Jagadeesan1, E. Driscoll2, B. Hao2, S. Cheng2, S. Barat3, T. Chen4, K. Borroto-Esoda3, D. Angulo3, C. J. Clancy2, M. Nguyen2; 1Univ. of Pittsburgh Med. Ctr., Pittsburgh, PA, 2Univ. of Pittsburgh, Pittsburgh, PA, 3Scynexis Inc., Jersey City, NJ, 4Scynexis Inc., Jersey City, NJ HighlightsAn in vitro study evaluating the efficacy of ibrexafungerp (IBX) and caspofungin (CAS) alone or in combination with azole treatments against 50 Aspergillus clinical isolates found that the combination of IBX or CAS with azole treatment yielded synergistic activity. These results support further investigations evaluating the potential for the use of ibrexafungerp and azoles in combination for the treatment of infections caused by Aspergillus. [Link to study details] All posters will be available on the SCYNEXIS website in the near future via link.About Ibrexafungerp Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a new class of antifungal agents called triterpenoids, which are broad-spectrum, fungicidal, and designated by the suffix “-fungerp”. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp 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 antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.Forward Looking Statement Statements contained in this press release regarding expected future events or results are "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 and obtain FDA approval for ibrexafungerp; 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 Irina Koffler Managing Director LifeSci Advisors, LLC 646-970-4681 (w) ikoffler@lifesciadvisors.comMedia Relations Gloria Gasaatura Account Supervisor LifeSci Communications 646-970-4688 ggasaatura@lifescicomms.com