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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 reported Q3 2021 results, highlighting BREXAFEMME sales of $0.5 million with 1,006 prescriptions, showing positive momentum into Q4. Insurance coverage for BREXAFEMME reached over 30% of commercially insured lives. The IV formulation of ibrexafungerp has progressed to clinical development after a successful Phase 1 trial. The company maintains a cash balance of $100 million, supporting operations into 2023. SCYNEXIS anticipates top-line data from the Phase 3 CANDLE study by early Q2 2022 and plans a supplemental NDA submission in Q2 2022.
SCYNEXIS, Inc. (NASDAQ: SCYX) recently completed a Phase 1 clinical study demonstrating the safety and tolerability of a liposomal IV formulation of ibrexafungerp. This double-blind, placebo-controlled trial involved 64 volunteers and confirmed that the formulation achieved target exposure without severe adverse events. Most reactions were mild and related to the infusion site. The company aims to utilize this formulation in diverse healthcare settings to combat severe fungal infections. Strategic options for optimizing development will be discussed soon.
SCYNEXIS, Inc. (NASDAQ: SCYX) has announced a conference call scheduled for November 10, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2021. The call will provide a corporate update on the company's pioneering efforts in developing innovative antifungal medicines, including the recently launched BREXAFEMME (ibrexafungerp), which was FDA-approved on June 1, 2021. Investors can access the live call via phone or webcast, with a replay available on the SCYNEXIS website for 90 days.
SCYNEXIS, Inc. (NASDAQ: SCYX) reported the publication of results from its Phase 3 VANISH-303 and Phase 2 DOVE studies for ibrexafungerp in the treatment of vulvovaginal candidiasis (VVC). In the VANISH-303 study, ibrexafungerp showed significant superiority over placebo in clinical cure rates (50.5% vs 28.6%) and mycological eradication (49.5% vs 19.4%). The DOVE study indicated that 300 mg BID for one day was optimal, with a clinical cure rate of 51.9%. These findings support the use of ibrexafungerp as a safe and effective treatment for VVC, providing new options for patients.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the presentation of pooled data from its VANISH clinical development program at two medical meetings in October 2021. This data supports the efficacy and safety of BREXAFEMME™ (ibrexafungerp tablets) for treating vulvovaginal candidiasis. BREXAFEMME is the first new antifungal class approved since the 1990s, filling a significant gap in women’s healthcare. The presentations will occur at the NPWH Conference and ISIDOG Congress, highlighting the company's commitment to innovation in tackling difficult-to-treat infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) reported promising preclinical data on ibrexafungerp's efficacy for treating mucormycosis, a rare and life-threatening fungal infection. The in vivo study demonstrated that ibrexafungerp monotherapy achieved survival rates similar to current standard therapies. When combined with amphotericin B, it significantly enhanced median and overall survival rates compared to monotherapy. The urgency for effective treatments is underscored by over 47,500 mucormycosis cases reported in India during the COVID-19 pandemic.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced that it will present interim data from its ongoing FURI and CARES studies on oral ibrexafungerp for refractory fungal infections at the 10th Trends in Medical Mycology meeting on October 8-11, 2021. In addition, pre-clinical data on ibrexafungerp for mucormycosis will be shared in an oral presentation. Ibrexafungerp is a novel antifungal agent, recently FDA-approved, showing promise against multidrug-resistant fungal infections. This ongoing clinical research aims to address an urgent need for effective oral treatments in hospitalized patients.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced promising interim results from the ongoing Phase 3 FURI study of ibrexafungerp, presented during IDWeek 2021. The analysis of 74 patients with severe fungal infections showed a 62.1% overall response rate, with notable efficacy in candidemia and intra-abdominal infections. The study highlights ibrexafungerp's potential for patients intolerant to standard treatments. The company continues to advance its position in the antifungal market, with emphasis on addressing drug-resistant infections.
SCYNEXIS, Inc. announced presentations of interim data from its Phase 3 FURI study at IDWeek 2021, focusing on ibrexafungerp for treating refractory fungal infections. The study includes 74 patients, highlighting outcomes for infections caused by Candida, especially drug-resistant strains. This is significant as invasive fungal infections are challenging to treat due to rising antifungal resistance. The company aims to make ibrexafungerp available to patients globally, following its FDA approval for BREXAFEMME in June 2021.
SCYNEXIS has launched BREXAFEMME® (ibrexafungerp tablets), the first oral non-azole treatment approved by the FDA for vulvovaginal candidiasis (VVC), a common vaginal yeast infection. This innovative antifungal, effective against azole-resistant strains, is available in pharmacies nationwide. BREXAFEMME is a two-day regimen designed to kill the fungi rather than just inhibit growth. The drug has received Qualified Infectious Disease Product status and has 10 years of market exclusivity. With a favorable safety profile and patent protection until at least 2035, SCYNEXIS aims to expand its antifungal franchise.
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