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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 3.37 million shares, gaining approximately $21.1 million. This follows an earlier $7.9 million received in December. The exercised warrants were part of Series 1 from a December 2020 financing. SCYNEXIS aims to bolster its financial position to support the commercialization of its first product, BREXAFEMME® (ibrexafungerp), approved by the FDA on June 1, 2021, alongside ongoing clinical trials targeting invasive fungal infections.
SCYNEXIS, Inc. has announced that its innovative antifungal treatment, BREXAFEMME (ibrexafungerp tablets), is now covered for over 45% of commercially insured patients in the U.S. This first-in-class treatment for vulvovaginal candidiasis (VVC) is the first new antifungal class approved by the FDA in more than 20 years. The coverage expansion is expected to enhance patient access, as it meets a significant unmet need in managing yeast infections, particularly those resistant to standard treatments.
SCYNEXIS, Inc. (NASDAQ: SCYX) has received orphan medicinal product designation from the EMA for ibrexafungerp to treat invasive candidiasis, granting 10 years of EU market exclusivity. The company also secured new U.S. and European patents extending lifecycle protection until 2038. The recent initiation of a global Phase 3 study for ibrexafungerp highlights its potential as an oral step-down therapy for invasive candidiasis. Ibrexafungerp is positioned as a significant treatment option against drug-resistant infections.
SCYNEXIS is launching a global Phase 3 study to assess the effectiveness of oral ibrexafungerp as a step-down treatment for invasive candidiasis (IC) and candidemia. This study aims to establish ibrexafungerp as the first non-azole oral option for IC caused by azole-resistant Candida species, which account for approximately 35,000 cases annually in the U.S. The study involves around 220 patients and compares ibrexafungerp to oral fluconazole following IV echinocandin therapy. The primary endpoint is 30-day all-cause mortality.
SCYNEXIS (NASDAQ: SCYX) announced the grant of stock options to two new employees for a total of 5,200 shares at an exercise price of $7.38 per share, which matches the closing price on November 30, 2021. These options are part of SCYNEXIS' inducement strategy under the 2015 Inducement Award Plan, designed to attract new talent. Each option has a ten-year term, with vesting set at one-fourth on the one-year anniversary and the remainder in equal monthly installments thereafter.
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.