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SCYNEXIS, Inc. (NASDAQ: SCYX) is a front-running pharmaceutical company dedicated to discovering, developing, and commercializing novel anti-infectives. Based in Jersey City, SCYNEXIS aims to address significant unmet therapeutic needs, particularly in the realm of fungal infections. Their primary product candidate, ibrexafungerp, is an innovative oral and intravenous drug targeting a wide range of serious and life-threatening invasive fungal infections.
SCYNEXIS is renowned for its groundbreaking antifungal platform known as “fungerps.” Ibrexafungerp, the first representative of this class, received FDA approval for treating vulvovaginal candidiasis (VVC) and for reducing the incidence of recurrent VVC. This compound is also in late-stage clinical trials targeting invasive fungal infections in hospitalized patients. SCYNEXIS is continuously advancing its pipeline with new antifungal candidates like SCY-247, which has shown promising preclinical results against multiple drug-resistant fungal pathogens.
In recent developments, SCYNEXIS voluntarily recalled two lots of BREXAFEMME® due to potential cross-contamination with a non-antibacterial beta-lactam substance. Although no adverse events have been reported, the company is taking proactive measures to address the issue and ensure consumer safety. Meanwhile, SCYNEXIS continues to make strides in research and development, with significant investments aimed at expanding their antifungal arsenal.
For more information about SCYNEXIS, Inc., including their latest news and updates, visit www.scynexis.com.
SCYNEXIS, a biotechnology company, announced the presentation of three posters on ibrexafungerp, a novel antifungal drug, at IDWeek 2020, held virtually from October 21-25, 2020. The posters highlight clinical and preclinical data showcasing ibrexafungerp's effectiveness against serious fungal infections, which claim over a million lives annually. On October 14, SCYNEXIS submitted a New Drug Application to the FDA for ibrexafungerp's use in treating vulvovaginal candidiasis, with a decision expected by mid-2021.
SCYNEXIS has submitted a New Drug Application (NDA) to the FDA for ibrexafungerp, intended to treat vulvovaginal candidiasis (VVC). This submission is backed by positive data from two Phase 3 studies demonstrating superiority over placebo. If accepted, the NDA could undergo a 6-month priority review due to its Qualified Infectious Disease Product status. With the vaginal yeast infection market expanding, SCYNEXIS aims to address unmet needs in treatment options. The company anticipates notification on NDA acceptance by December 2020.
SCYNEXIS, a biotechnology firm, announced the presentation of two posters at the Nurse Practitioners in Women Health’s (NPWH) conference from October 15 to 18, 2020. These posters will showcase Phase 3 data on ibrexafungerp, an investigational antifungal treatment for vulvovaginal candidiasis (VVC), effective against both fluconazole-susceptible and resistant strains of Candida. Dr. Nkechi Azie emphasized the urgent need for new treatments due to increasing drug resistance among current therapies. More details are available on the SCYNEXIS website.
SCYNEXIS, a biotechnology firm, announced Dr. Marco Taglietti's participation in H.C. Wainwright’s 22nd Annual Global Investment Healthcare Conference from September 14-16, 2020. He will speak on September 15 at 2:30 p.m. ET. Additionally, Dr. Taglietti will join a panel at Maxim’s antifungal webinar on September 17, 2020, at 11:00 a.m. ET, discussing fungal diseases. A webcast of the HCW conference will be available on the SCYNEXIS website for 30 days post-event.
SCYNEXIS focuses on innovative therapies for difficult infections and is developing ibrexafungerp for serious fungal infections.
SCYNEXIS (NASDAQ: SCYX) is set to submit a New Drug Application (NDA) for ibrexafungerp, a treatment for Vulvovaginal Candidiasis (VVC), in Q4 2020. This follows positive pre-NDA meetings with the FDA, where the company confirmed its clinical data package. Ibrexafungerp could be the first new antifungal class approved in 20 years and is the only oral, non-azole option for women with VVC. SCYNEXIS has shown statistical superiority in Phase 3 trials and is also progressing another study for recurrent VVC, anticipating results in H2 2021.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the presentation of four posters at ASM Microbe 2020, showcasing the potential of ibrexafungerp, a novel antifungal agent. After completing its VANISH Phase 3 program, SCYNEXIS plans to submit a new drug application for ibrexafungerp for treating vaginal yeast infections this year. The posters emphasized ibrexafungerp's efficacy against various fungal infections, including drug-resistant strains. Notably, interim analysis from the Phase 3 FURI study showed significant clinical benefits in 81% of patients intolerant to standard antifungal treatments.
SCYNEXIS will host a webcast on July 14, 2020, at 10am ET to discuss the significant impact of vaginal yeast infections, with a focus on their innovative drug candidate, ibrexafungerp. This event follows positive top-line results from two Phase 3 trials for vulvovaginal candidiasis (VVC), with a planned NDA submission in the latter half of 2020. Key opinion leaders will address the existing treatment gaps and the commercial potential of ibrexafungerp in the VVC market, underscoring SCYNEXIS's commitment to advancing solutions in women's health.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced a presentation at the BIO Digital International Convention from June 8-12, 2020. CEO Marco Taglietti will discuss the company's progress towards becoming a fully integrated commercial entity, targeting the treatment of vaginal yeast infections. The presentation will highlight the positive Phase 3 VANISH program for oral ibrexafungerp, with an NDA submission expected in mid-2021. SCYNEXIS focuses on developing innovative antifungal therapies to combat drug-resistant infections, leveraging expertise in anti-infective drug development.
SCYNEXIS, Inc. (NASDAQ: SCYX) has appointed Jim Maffezzoli as the new Vice President of Marketing and Sales, effective June 1, 2020. Maffezzoli brings almost 20 years of experience in women’s health marketing and will oversee the commercialization of ibrexafungerp, an investigational treatment for vaginal yeast infections.
With an NDA submission for ibrexafungerp anticipated in the second half of 2020, this strategic appointment aims to enhance the company’s marketing efforts in women's health, addressing a significant unmet need in the treatment landscape.
SCYNEXIS announced positive results from the Phase 3 VANISH-306 study for oral ibrexafungerp, aimed at treating vaginal yeast infections, with an NDA submission expected in H2 2020. Concurrently, enrollment continues in the Phase 3 CANDLE study for recurrent infections. The company also reported positive interim results from the Phase 3 FURI study for severe fungal infections, showing an 83% clinical benefit in 41 patients. Financially, SCYNEXIS strengthened its position with $10 million in convertible notes and a $20 million stock purchase agreement, ensuring a cash runway into mid-2021.
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