SCYNEXIS, Inc. - SCYX STOCK NEWS

SCYNEXIS, Inc. has published a review highlighting the antifungal ibrexafungerp's potential against deadly fungal infections listed by the WHO. This novel treatment shows promise for immunocompromised patients facing invasive mold infections. Ibrexafungerp is noted for its effectiveness against drug-resistant species and its convenient oral dosing. Ongoing clinical trials aim to further validate its efficacy in treating mold infections. The widespread resistance to current antifungal treatments underscores the urgent need for novel therapies like ibrexafungerp.

SCYNEXIS announced positive results from a pooled analysis of two Phase 3 studies, VANISH-303 and VANISH-306, published in the Journal of Women’s Health. Ibrexafungerp demonstrated statistically significant superior clinical cure rates, complete symptom resolution, and mycological cure compared to placebo (p < 0.0001). The data supports its potential as an effective treatment for vulvovaginal candidiasis (VVC), indicating consistent efficacy across various patient sub-populations. Ibrexafungerp is well-tolerated with mild gastrointestinal adverse events.

SCYNEXIS, Inc. (NASDAQ: SCYX) has scheduled a conference call for November 9, 2022, at 8:30 a.m. EDT to discuss its third-quarter financial results for the period ending September 30, 2022. The company, focused on developing innovative medicines for drug-resistant infections, has received FDA approval for its antifungal product, BREXAFEMME, and filed a supplemental New Drug Application for expanded indications, with a target FDA action date of November 30, 2022. The call will also provide corporate updates and insights into ongoing clinical trials.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced the appointment of Ivor Macleod as Chief Financial Officer, bringing over 30 years of biopharma experience. Macleod will support the company's strategic shift towards hospital-based antifungal treatments, specifically ibrexafungerp, a first-in-class antifungal agent. He previously served as CFO at Athersys, Inc. and Eisai Inc. In connection with his appointment, he received stock options for 170,000 shares at $2.22 and 15,000 RSUs. The company also aims to expand BREXAFEMME's labeling to prevent recurrent vulvovaginal candidiasis, with a PDUFA date set for November 30, 2022.

SCYNEXIS, Inc. (NASDAQ: SCYX) presented interim results from the ongoing Phase 3 FURI study at IDWeek 2022, showing positive clinical outcomes from ibrexafungerp treatment. The study highlights an 82.3% positive outcome rate across various fungal diseases and a 94.6% survival rate at 30 days post-treatment for patients with invasive candidiasis. With data from 113 patients, most had invasive candidiasis/candidemia, demonstrating significant therapeutic response rates. SCYNEXIS aims for salvage therapy indication, reinforcing its commitment to developing ibrexafungerp to address challenging fungal infections.

SCYNEXIS (NASDAQ: SCYX) has announced a new strategic direction to focus on the clinical development of ibrexafungerp for severe, hospital-based fungal infections, with first approval anticipated in 2024. The company plans to out-license BREXAFEMME for vulvovaginal candidiasis (VVC) while winding down promotional activities and concluding its partnership with Amplity Health, leading to a workforce reduction. These moves aim to extend the cash runway into Q2 2024. Additionally, SCYNEXIS is undergoing changes in executive leadership with a new CEO taking charge in January 2023.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced that interim data from the Phase 3 FURI study on oral ibrexafungerp will be presented at IDWeek 2022 in Washington, D.C., from October 19-23, 2022. The presentations will cover all-cause mortality in patients with invasive candidiasis and outcomes by fungal disease, emphasizing ibrexafungerp's potential in treating drug-resistant infections. Ibrexafungerp, a novel antifungal agent, is in late-stage development for severe fungal infections and received multiple designations from the FDA and EMA to expedite its path to market.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced that Marco Taglietti, President and CEO, will present at the H.C. Wainwright Annual Global Investment Conference on September 14, 2022, from 3:30 p.m. to 4:00 p.m. EDT, and at the Ladenburg Thalmann Annual Healthcare Conference on September 29, 2022, from 12:00 p.m. to 12:25 p.m. EDT. Both presentations will include company insights and 1:1 meetings with attendees. SCYNEXIS focuses on innovative medicines to combat drug-resistant infections, with their lead product, BREXAFEMME, approved by the FDA on June 1, 2021.

SCYNEXIS recently presented positive interim data from two Phase 3 studies: FURI and CARES, focusing on the antifungal ibrexafungerp. In the FURI study, 83% of patients with refractory Candida infections showed positive clinical outcomes, with 56% achieving complete or partial responses. The CARES study reported an 89% positive outcome in patients with Candida auris infections, with a 78% complete or partial response rate. These results highlight ibrexafungerp's potential against multi-drug resistant fungal infections, representing a significant advancement in treatment options.