SCYNEXIS Inc
NASDAQ:SCYX
SCYNEXIS Inc
SCYNEXIS, Inc. is a biotechnology company, which engages in the development of novel oral and intravenous triterpenoid antifungal for the treatment of several serious fungal infections, including vulvovaginal candidiasis, invasive aspergillosis, invasive candidiasis, and refractory invasive fungal infections. The company is headquartered in Jersey City, New Jersey and currently employs 56 full-time employees. The company went IPO on 2014-05-02. The firm is developing its lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (IV)/oral agent for multiple fungal indications in both the community and hospital settings. The company has received the approval from the United States Food and Drug Administration (FDA) for the New Drug Application (NDA) for BREXAFEMME (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC, also known as vaginal yeast infection). BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC). The company is also continuing late-stage clinical development of ibrexafungerp for multiple indications, including the treatment of life-threatening invasive fungal infections in hospitalized patients.
SCYNEXIS, Inc. is a biotechnology company, which engages in the development of novel oral and intravenous triterpenoid antifungal for the treatment of several serious fungal infections, including vulvovaginal candidiasis, invasive aspergillosis, invasive candidiasis, and refractory invasive fungal infections. The company is headquartered in Jersey City, New Jersey and currently employs 56 full-time employees. The company went IPO on 2014-05-02. The firm is developing its lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (IV)/oral agent for multiple fungal indications in both the community and hospital settings. The company has received the approval from the United States Food and Drug Administration (FDA) for the New Drug Application (NDA) for BREXAFEMME (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC, also known as vaginal yeast infection). BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC). The company is also continuing late-stage clinical development of ibrexafungerp for multiple indications, including the treatment of life-threatening invasive fungal infections in hospitalized patients.
Revenue Growth: BREXAFEMME net product revenue reached $1.6 million in Q3 2022, up 23% from the previous quarter.
Refocused Strategy: SCYNEXIS is shifting resources toward developing ibrexafungerp for severe, hospital-based fungal infections, while seeking partners for BREXAFEMME commercialization.
PDUFA Date: Supplemental NDA for BREXAFEMME in recurrent VVC is on track, with a PDUFA decision expected November 30, 2022.
Cash Runway: Company ended Q3 with $96.1 million in cash, expected to fund operations into Q2 2024.
Prescription Growth: BREXAFEMME prescriptions grew 30% quarter-over-quarter to nearly 5,800 in Q3, but Q4 sales are expected to decline due to the end of in-person promotion.
Pipeline Progress: Clinical studies for ibrexafungerp (FURI, CARES, SCYNERGIA, MARIO) are on track, with key data readouts and regulatory filings anticipated in 2023 and 2024.
Market Access: BREXAFEMME gained coverage for 130 million commercially insured lives following a major PBM contract.
