SCYNEXIS, Inc. - SCYX STOCK NEWS

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.

SCYNEXIS (NASDAQ: SCYX) announced positive outcomes from the CANDLE study on ibrexafungerp for recurrent vulvovaginal candidiasis (RVVC) in patients who failed fluconazole treatment. Of 24 patients, 71% experienced significant symptom reduction after a one-day ibrexafungerp regimen. The promising results indicate that ibrexafungerp may be an effective option for difficult-to-treat cases of acute VVC. SCYNEXIS will present further findings at the IDSOG Annual Meeting in Boston from August 4-6, 2022, and the Phase 3b VANQUISH study is underway to evaluate the treatment's efficacy.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced the presentation of data from the CANDLE 304s sub-study on ibrexafungerp at the ISSVD XXVI World Congress in Dublin, Ireland, from July 15-20, 2022. The oral presentation titled 'Outcomes of Oral Ibrexafungerp in Patients with Vulvovaginal Candidiasis who Failed Fluconazole Therapy' will be delivered by Jack Sobel M.D. on July 19, 2022, from 2:00 p.m. to 2:10 p.m. IST. Ibrexafungerp is a novel antifungal agent targeting drug-resistant infections, currently in late-stage development for multiple life-threatening fungal infections.

SCYNEXIS, Inc. (NASDAQ: SCYX) has initiated a Phase 3b study (VANQUISH) to assess the efficacy and safety of oral ibrexafungerp in treating complicated vulvovaginal candidiasis (VVC) in patients who have not responded to fluconazole. The study will enroll approximately 150 participants, evaluating various dosing regimens for those with difficult-to-treat VVC. Previous studies indicated a 71% success rate with ibrexafungerp among patients with relapsed cases. This effort reflects the growing need for alternative antifungal options for women facing severe infections.

SCYNEXIS, Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for an additional indication of BREXAFEMME (ibrexafungerp) for preventing recurrent vulvovaginal candidiasis (RVVC). This follows positive data from the Phase 3 CANDLE study, where ibrexafungerp showed significant superiority over placebo, with 65.4% of patients achieving clinical success versus 53.1% in placebo (p=0.02). If approved, BREXAFEMME would be the first oral non-azole treatment for RVVC. The drug is generally safe, with mild adverse reactions.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced stock options grants totaling 23,000 shares to three new employees, incentivizing their acceptance of job offers. The options, priced at $2.11 per share, are part of SCYNEXIS' 2015 Inducement Award Plan. Each option has a ten-year term, with one-fourth of shares vesting after one year, followed by monthly vesting for three years, contingent on continued employment. SCYNEXIS focuses on innovative antifungal treatments, with its product BREXAFEMME recently approved by the FDA.