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JERSEY CITY, N.J. - SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company currently valued at $28.46 million, announced Monday that it has recommenced patient dosing in its Phase 3 MARIO study for the antifungal treatment ibrexafungerp, following a pause due to FDA concerns over potential cross-contamination in manufacturing. The FDA has since lifted the clinical hold after the company produced new clinical supplies at a different facility. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 5.83, suggesting ample resources to support its clinical programs.
The MARIO study is examining the use of oral ibrexafungerp as a possible step-down therapy from IV echinocandin for invasive candidiasis, a serious infection. Success in the study and subsequent FDA approval would allow healthcare providers to transition patients to a non-azole oral therapy that maintains the same mechanism of action as IV echinocandins, the standard treatment for invasive Candida infections.
The dosing of the first new patient reportedly triggers a $10 million milestone payment from GSK to SCYNEXIS, with an additional $20 million due six months post-dosing. However, GSK disputes its obligation to make these payments, a position SCYNEXIS is actively contesting. InvestingPro analysis indicates the company holds more cash than debt on its balance sheet, potentially strengthening its position during this dispute.
Dr. David Angulo, President and CEO of SCYNEXIS, expressed satisfaction with the rapid resumption of the study, citing the scientific community’s eagerness for new treatments. Approximately 25% of the projected patient enrollment has been completed.
Experts like Dr. Barbara D. Alexander of Duke University and Dr. Luis Ostrosky-Zeichner of UTHealth Houston emphasized the urgent need for new treatments, especially against resistant Candida strains, and welcomed the study’s restart.
Ibrexafungerp, part of a new class of antifungals known as fungerps, has shown promise against multidrug-resistant pathogens, including strains resistant to current antifungal medications. It is already approved in the U.S. for the treatment of vulvovaginal candidiasis, with ongoing development for invasive candidiasis.
This news is based on a press release statement from SCYNEXIS, which is working to resolve the payment disagreement with GSK. The company continues to pioneer its proprietary antifungal platform with the aim of addressing the global challenge of drug-resistant infections. Despite trading near its 52-week low, analysts maintain a bullish outlook with price targets ranging from $4 to $6. InvestingPro’s Fair Value analysis suggests the stock may be currently undervalued, with additional metrics and insights available to subscribers.
In other recent news, SCYNEXIS, Inc. has presented promising preclinical data for its antifungal candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases conference in Vienna. The data highlights SCY-247’s potential effectiveness against multi-drug resistant fungi, including strains like Candida auris, which are difficult to treat. Studies from the University of Texas, Houston, and a hospital in Madrid demonstrated SCY-247’s antifungal activity against various clinical yeast isolates. Notably, SCY-247 retained its activity against most strains resistant to current antifungal treatments, though some challenges were noted with specific Candida glabrata isolates. SCY-247 is part of a new class of glucan synthase inhibitors and is currently in Phase 1 development. SCYNEXIS anticipates potential Fast Track and Qualified Infectious Disease Product designations from the U.S. FDA for both IV and oral formulations of SCY-247. This compound represents a significant development as it belongs to the first new class of antifungal compounds approved since 2001. SCYNEXIS’s first fungerp, ibrexafungerp, has already received FDA approval for indications related to vulvovaginal candidiasis. The company’s broader mission focuses on addressing antimicrobial resistance in systemic fungal diseases.
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