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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, a biotechnology company, has announced its presentation of interim data on various infection types from the ongoing Phase 3 FURI and CARES studies, along with the innovative MARIO trial design. This will occur at the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) from April 15-18, 2023, in Copenhagen, Denmark. Key presentations include:
- Oral Ibrexafungerp outcomes in urinary tract infections.
- Evaluation of Ibrexafungerp's efficacy alone and with other antifungals.
- A novel protocol for Ibrexafungerp as step-down therapy.
Ibrexafungerp, a groundbreaking antifungal agent, shows promise against drug-resistant infections. It has received FDA designations for invasive candidiasis and aspergillosis, highlighting its potential in treating difficult infections.
SCYNEXIS has secured an exclusive agreement with GSK for the commercialization and development of BREXAFEMME (ibrexafungerp), including an upfront payment of $90 million and potential future milestone payments totaling $503 million. The company retains rights to all other fungerp assets. As of Q4 2022, SCYNEXIS reported $1.4 million in net sales for BREXAFEMME with 5,125 prescriptions written. The company has completed enrollment in several Phase 2 and Phase 3 trials for ibrexafungerp and has a projected cash runway of over two years post-GSK transaction. However, net loss for 2022 was $62.8 million.
SCYNEXIS, Inc. (NASDAQ: SCYX) has signed an exclusive licensing agreement with GSK for Brexafemme (ibrexafungerp tablets), an FDA-approved antifungal for vulvovaginal candidiasis (VVC). The deal includes a $90 million upfront payment, potential milestone payments of $503 million, and tiered royalties. GSK will commercialize Brexafemme while SCYNEXIS retains rights to assets derived from enfumafungin. The agreement enhances GSK's infectious disease portfolio, focusing on addressing antimicrobial resistance and improving treatment options for patients, especially those suffering from recurrent infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the FDA approval of BREXAFEMME (ibrexafungerp), the first non-azole oral therapy for treating vulvovaginal candidiasis (VVC) and reducing recurrent VVC incidence. Approval was based on the Phase 3 CANDLE study, showing ibrexafungerp's clinical success at 65.4% versus 53.1% for placebo (p=0.02). BREXAFEMME is aimed at empowering patients with recurrent infections and is positioned for commercialization in the U.S.
SCYNEXIS announced that researchers at Case Western Reserve University have received over $3 million from the NIH to study SCY-247, an antifungal targeting Candida auris, a multidrug-resistant pathogen. This five-year grant will evaluate the efficacy of SCY-247, a second-generation fungerp, in treating serious infections. C. auris has a high mortality rate and limited treatment options, prompting the need for new therapies. SCY-247 is under early development but shows promise in combating drug resistance.
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