Scynexis Receives FDA QIDP and FTD Designations
Scynexis announced that the U.S. Food and Drug Administration, FDA, has granted the Company Qualified Infectious Disease Product, QIDP, and Fast Track Designations, FTD, for its second-generation triterpenoid antifungal therapy, SCY-247. In 2026, the Company expects to initiate a Phase 1 study of SCY-247 with the IV formulation as well as a Phase 2 study with the oral formulation in invasive candidiasis. Scynexis also aims to release proof-of -concept data for the oral formulation of SCY-247 in IC in 2026. Considering the differentiated attributes of SCY-247 and its potential role to counter health security threats posed by antifungal resistance development, the company will also continue exploring potential non-dilutive funding opportunities to further support this program.
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SCYNEXIS Secures FDA QIDP Designation for SCY-247, Ensuring 10 Years of Market Exclusivity
- FDA Designation: SCYNEXIS's SCY-247 has received QIDP and Fast Track designations from the FDA, ensuring at least 10 years of market exclusivity post-approval, thereby enhancing the company's competitive edge in the antifungal market.
- Clinical Trial Plans: The company expects to initiate a Phase 1 study of SCY-247 with the IV formulation and a Phase 2 study with the oral formulation in 2026, aiming to address the treatment needs for invasive candidiasis and further advance product development.
- Antifungal Activity: SCY-247 has demonstrated potent activity against various difficult-to-treat fungal pathogens, including multi-drug-resistant Candida auris, in multiple preclinical studies, indicating its potential to combat public health threats.
- Market Demand: As the threat of multi-drug resistant fungal infections escalates, the development of SCY-247 not only meets the urgent market need for novel antifungal agents but also holds the potential for significant economic returns for the company.
Scynexis Reveals Federal Support for Partnership Between Hackensack Meridian CDI and Johns Hopkins Researchers to Create Innovative Therapies, Including New Fungerps, for Resistant Fungal Infections
Federal Grant Announcement: SCYNEXIS, Inc. has received a five-year federal grant of $7 million annually to support the development of new antifungal therapeutics, particularly next-generation triterpenoid antifungals (fungerps), aimed at combating resistant fungal infections.
Research Collaboration: The grant will establish a Center of Excellence in Translational Research (CETR) in collaboration with Hackensack Meridian Center for Discovery and Innovation and Johns Hopkins Bloomberg School of Public Health, focusing on advancing fungerp candidates from preclinical stages to IND-ready status.
Fungal Infection Statistics: Approximately four million deaths annually are attributed to fungal infections globally, highlighting the urgent need for new therapeutics to address the growing threat of resistant fungal pathogens.
Triterpenoid Antifungals Overview: Triterpenoid antifungals represent a novel class of glucan synthase inhibitors, with the first compound, Ibrexafungerp, already approved for treating vulvovaginal candidiasis, while additional candidates are in various stages of development to tackle multidrug-resistant fungal infections.
