SCYNEXIS Inc. (SCYX) has plunged -8.12% at $4.75 in pre-market trading hours on the last check Thursday. The stock of SCYNEXIS (SCYX) gained 2.99% to complete the last trading session at $5.17. The price range of the company’s shares was between $4.99 and $5.22. SCYX traded 135K shares, which was below its daily average of 0.31 million shares over 100 days. SCYX shares have gained by 9.77% in the last five days, while they have lost -13.40% in the last month. SCYX stock is losing even after announcing positive results from the pivotal study.
Which SCYNEXIS study showed positive outcomes?
SCYNEXIS (SCYX) is a biotechnology organization spearheading creative medications to help a large number of patients overall survive and forestall challenging to-treat contaminations that are turning out to be progressively drug-safe. SCYX researchers are fostering the organization’s lead resource, ibrexafungerp (previously known as SCY-078), as a wide range, foundational antifungal for long time signs in both the local area and medical clinic settings. SCYXS has started the send-off of its first business item in the U.S., BREXAFEMME (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) supported BREXAFEMME on June 1, 2021.
SCYNEXIS (SCYX) today reported positive outcomes from its worldwide Phase 3 CANDLE concentrate on exploring the security and viability of oral ibrexafungerp for counteraction of intermittent vulvovaginal candidiasis (rVVC), otherwise called vaginal yeast contamination. SCYX plans to present the outcomes to the FDA in the primary portion of 2022 and expects to get endorsement by year-end.
- Ibrexafungerp is the main oral fungicidal specialist to effectively finish urgent preliminaries in both the intense therapy and anticipation of yeast diseases.
- As just non-azole, ibrexafungerp is changing how yeast diseases are dealt with.
- These significant outcomes support an extra sign for BREXAFEMME for the counteraction of rVVC.
- This intriguing accomplishment is one more advance in SCYX’s endeavors to bring to showcase significant and inventive arrangements in the battle against a wide scope of contagious diseases and improve investor esteem.
- This preliminary was led by SCYX under a Special Protocol Assessment (SPA), an interaction where backers work with the FDA to agree on the plan and size of a clinical preliminary to enough address logical and administrative prerequisites for a review that could uphold promoting endorsement.
Which purpose does the SCYX study served?
SCYNEXIS (SCYX) Phase 3 CANDLE concentrate on assessing the adequacy and security of oral ibrexafungerp contrasted with fake treatment in 260 female patients with rVVC, characterized as at least three episodes of VVC in the past year. All patients at first got a multi-day routine of fluconazole, and responders were randomized to get either 300 mg ibrexafungerp BID or matching fake treatment one day a month, for a very long time. The essential endpoint was viability as estimated by the level of subjects with clinical accomplishment at trial of-fix (24 weeks).
