Welcome to our dedicated page for Scynexis news (Ticker: SCYX), a resource for investors and traders seeking the latest updates and insights on Scynexis stock.
SCYNEXIS, Inc. develops therapies for severe rare diseases and difficult-to-treat fungal infections. The company’s updates center on SCY-770, a clinical-stage oral direct AMPK activator for autosomal dominant polycystic kidney disease, and SCY-247, a second-generation triterpenoid antifungal therapy in development for invasive candidiasis and prophylaxis of invasive fungal disease.
SCYNEXIS news also covers its fungerp antifungal platform, FDA designations for SCY-247, scientific presentations, financial results, and corporate actions. The company has licensed ibrexafungerp, including BREXAFEMME® for vulvovaginal candidiasis and reduction in recurrent vulvovaginal candidiasis, to GSK, making collaboration and license-agreement updates a recurring disclosure theme.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the exercise of warrants for 1.2 million shares by major stockholders, generating approximately $7.9 million. The warrants were part of a financing round from December 2019, with the remaining 3.2 million shares expiring unexercised. CEO Marco Taglietti highlighted this as a vote of confidence in the company's future, particularly following the launch of SCYNEXIS's first U.S. commercial product, BREXAFEMME, and ongoing clinical development for treating serious fungal infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced that its product, BREXAFEMME® (ibrexafungerp tablets), has received the Popular Science 2021 “Best of What’s New” award in the Health category. This award highlights BREXAFEMME as the first new antifungal class approved by the FDA in over 20 years, specifically for the treatment of vaginal yeast infections. The endorsement came after positive Phase 3 study results demonstrating its efficacy and tolerability. BREXAFEMME represents a significant advancement for patients suffering from vulvovaginal candidiasis.
SCYNEXIS, Inc. (NASDAQ: SCYX) has announced a webcast on December 6 at 10 a.m. ET, focusing on the hospital pipeline update for their antifungal, ibrexafungerp. The event will feature Dr. Martin Hoenigl from UC San Diego discussing the urgent need for novel antifungals. SCYNEXIS executives will outline the updated pipeline and strategies, highlighting the expanded use of ibrexafungerp in hospitals. As a broad-spectrum antifungal, ibrexafungerp is pivotal for treating various serious fungal infections.
SCYNEXIS, Inc. announced positive results from its Phase 3 VANISH-306 study, published in the International Journal of Obstetrics and Gynaecology. Patients treated with oral ibrexafungerp showed significantly higher rates of clinical cure (63.3% vs. 44.0% placebo), mycological eradication (58.5% vs. 29.8% placebo), and clinical improvement (72.3% vs. 54.8% placebo) at Day-10. At a Day-25 follow-up, 73.9% of patients reported complete symptom resolution. Ibrexafungerp, FDA-approved in June 2021, is positioned as a groundbreaking treatment for vulvovaginal candidiasis, demonstrating safety and tolerability in clinical trials.
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.