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SCYNEXIS, Inc. (NASDAQ: SCYX) is a front-running pharmaceutical company dedicated to discovering, developing, and commercializing novel anti-infectives. Based in Jersey City, SCYNEXIS aims to address significant unmet therapeutic needs, particularly in the realm of fungal infections. Their primary product candidate, ibrexafungerp, is an innovative oral and intravenous drug targeting a wide range of serious and life-threatening invasive fungal infections.
SCYNEXIS is renowned for its groundbreaking antifungal platform known as “fungerps.” Ibrexafungerp, the first representative of this class, received FDA approval for treating vulvovaginal candidiasis (VVC) and for reducing the incidence of recurrent VVC. This compound is also in late-stage clinical trials targeting invasive fungal infections in hospitalized patients. SCYNEXIS is continuously advancing its pipeline with new antifungal candidates like SCY-247, which has shown promising preclinical results against multiple drug-resistant fungal pathogens.
In recent developments, SCYNEXIS voluntarily recalled two lots of BREXAFEMME® due to potential cross-contamination with a non-antibacterial beta-lactam substance. Although no adverse events have been reported, the company is taking proactive measures to address the issue and ensure consumer safety. Meanwhile, SCYNEXIS continues to make strides in research and development, with significant investments aimed at expanding their antifungal arsenal.
For more information about SCYNEXIS, Inc., including their latest news and updates, visit www.scynexis.com.
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.
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.
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