Scynexis Stock Price, News & Analysis

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.

SCYNEXIS, a biotechnology company, announced its participation in four medical conferences in September 2022, showcasing their lead product, ibrexafungerp, aimed at treating drug-resistant fungal infections.

The conferences include:

• MSGERC Biennial Meeting (Sept 7-9, Albuquerque) - Presenting outcomes from studies on Candida infections.
• World Anti-Microbial Resistance Congress (Sept 7-9, National Harbor) - Presenting on Candida auris.
• ICHS (Sept 8-11, Basel) - Discussion on chronic mucocutaneous candidiasis.
• ISHAM Congress (Sept 20-24, New Delhi) - Presenting mortality data from fungal infections.

SCYNEXIS reported a 29% increase in prescriptions for BREXAFEMME in Q2 2022, generating net revenues of $1.3 million, up from $0.7 million in Q1. The FDA has set a PDUFA action date of November 30, 2022, for a supplemental NDA to expand BREXAFEMME's labeling for recurrent vulvovaginal candidiasis. The company has a robust cash balance of $118.7 million, ensuring a cash runway into Q1 2024. SCYNEXIS commenced two Phase 3 trials for ibrexafungerp, targeting invasive candidiasis and recurrent vulvovaginal candidiasis, with promising clinical outcomes reported from recent studies.

SCYNEXIS, Inc. (NASDAQ: SCYX) has scheduled a conference call and live webcast on August 15, 2022, at 8:30 a.m. EDT to discuss its financial results for Q2 ended June 30, 2022. The company, focusing on innovative antifungal medicines, recently introduced BREXAFEMME, FDA-approved on June 1, 2021, for treating difficult-to-treat infections. The call will provide a corporate update, enhancing transparency for investors. Details for joining the call are provided, with a replay available for 90 days on the company’s website.

SCYNEXIS reported positive results from the Phase 3 CANDLE study on ibrexafungerp, demonstrating a 65.4% clinical success rate in preventing recurrent vulvovaginal candidiasis (RVCC) versus 53.1% in placebo. The treatment also indicated 70.8% no mycologically proven recurrence compared to 58.5% for placebo. A supplemental NDA has been submitted for RVCC prevention, anticipating FDA review by November 30, 2022. Ibrexafungerp presents a new oral antifungal option, showing effective results in patients unresponsive to fluconazole.

SCYNEXIS announced that the FDA has accepted its supplemental New Drug Application for BREXAFEMME (ibrexafungerp) targeting the prevention of recurrent vulvovaginal candidiasis, with a decision date set for November 30, 2022.

If approved, BREXAFEMME will be the first therapy in the U.S. for both treating and preventing this condition. The application is supported by positive results from the Phase 3 CANDLE study, demonstrating significant efficacy over placebo. SCYNEXIS will present these results at the IDSOG Annual Meeting in Boston from August 4-6, 2022.