Welcome to our dedicated page for Scynexis news (Ticker: SCYX), a resource for investors and traders seeking the latest updates and insights on Scynexis stock.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company developing antifungal medicines based on its proprietary triterpenoid antifungal platform known as "fungerps." News about SCYNEXIS frequently centers on clinical data, regulatory interactions, collaborations, and its exclusive license agreement with GSK for ibrexafungerp, the active ingredient in the FDA-approved product BREXAFEMME for vulvovaginal candidiasis and reduction in the incidence of recurrent VVC.
On this page, readers can follow company announcements related to the development of next-generation fungerps, including SCY-247, which SCYNEXIS describes as a second-generation triterpenoid antifungal under clinical and preclinical evaluation for invasive fungal infections. Recent updates have highlighted positive Phase 1 single and multiple ascending dose results, preclinical data presented at scientific congresses, and plans for additional studies using both oral and intravenous formulations.
SCYNEXIS news also covers key events in its collaboration with GSK, such as the transfer of the BREXAFEMME New Drug Application, resolution of disagreements regarding the Phase 3 MARIO study in invasive candidiasis, and associated milestone or other payments. Regulatory and listing developments, including Nasdaq minimum bid price notices and extensions to regain compliance, are disclosed through company press releases and SEC filings.
Investors, clinicians, and researchers can use this news feed to review updates on clinical trial progress, antifungal data presentations, license agreement developments, and corporate milestones. Regularly checking this page helps users track how SCYNEXIS advances its fungerp platform, manages its partnership with GSK, and responds to regulatory and market requirements.
SCYNEXIS has launched BREXAFEMME® (ibrexafungerp tablets), the first oral non-azole treatment approved by the FDA for vulvovaginal candidiasis (VVC), a common vaginal yeast infection. This innovative antifungal, effective against azole-resistant strains, is available in pharmacies nationwide. BREXAFEMME is a two-day regimen designed to kill the fungi rather than just inhibit growth. The drug has received Qualified Infectious Disease Product status and has 10 years of market exclusivity. With a favorable safety profile and patent protection until at least 2035, SCYNEXIS aims to expand its antifungal franchise.
SCYNEXIS has announced that its partner, Hansoh Pharma, has filed an IND application for a Phase 3 study of ibrexafungerp in China, targeting vulvovaginal candidiasis. This follows an exclusive licensing agreement between the companies to develop and commercialize ibrexafungerp in the region. Ibrexafungerp is the first new antifungal drug approved by the FDA in over two decades, emphasizing its potential in combating drug-resistant infections. The collaboration aims to leverage Hansoh's capabilities to enhance treatment accessibility for patients in China.
SCYNEXIS, a biotechnology company focused on innovative treatments for drug-resistant infections, will participate in two upcoming virtual investor conferences in September 2021. The conferences include the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, featuring an on-demand presentation and one-on-one meetings, and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 30, with a live presentation. More information and archived webcasts will be available on their website for 30 days post-event.
SCYNEXIS announced financial results for Q2 2021, showcasing a strong cash position of $112.4 million. The company reported a net income of $1.7 million, reversing a loss of $6.4 million from the previous year. BREXAFEMME, the first FDA-approved antifungal in over 20 years, launched in August 2021, with positive payer engagement. Clinical advancements include completing enrollment in the Phase 3 CANDLE study and ongoing Phase 1 trials for a liposomal IV formulation. The company expects to sustain operations into 2023 driven by anticipated sales of BREXAFEMME.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the granting of stock options to five new employees, allowing them to purchase a total of 24,500 shares at an exercise price of $6.97 per share, the closing price on July 30, 2021. This grant serves as an incentive for accepting job offers and will vest over a four-year period. SCYNEXIS focuses on developing innovative antifungal treatments, including the recently FDA-approved BREXAFEMME (ibrexafungerp), targeting drug-resistant infections in both community and hospital settings.
SCYNEXIS, Inc. (NASDAQ: SCYX) presented data from two Phase 3 studies (VANISH-303 and VANISH-306) on oral ibrexafungerp for treating vulvovaginal candidiasis (VVC). The studies targeted patients with severe yeast infections and showed ibrexafungerp's efficacy and safety. Results indicated a Clinical Cure Rate of 56.9% for ibrexafungerp compared to 35.7% for placebo (p=0.001). The FDA approved BREXAFEMME® for the treatment of VVC, marking a significant milestone as the first new class of antifungal agent in over 20 years. Further studies are ongoing for recurrent VVC prevention.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced promising presentations for ibrexafungerp at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The data highlight ibrexafungerp's effectiveness against challenging fungal infections, including drug-resistant Candida auris. In vitro studies showed broad activity of ibrexafungerp against 967 clinical isolates in Denmark. From the FURI study, 70% of patients with refractory fungal diseases demonstrated clinical improvement, while 80% of patients in the CARES study achieved a complete response for Candida auris infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) has announced that CFO Eric Francois will present at Ladenburg Thalmann’s virtual Healthcare Conference on July 14, 2021, from 11:00 to 11:25 AM ET. This presentation will highlight the company’s innovative medicines aimed at combating drug-resistant infections, particularly their lead asset, ibrexafungerp. The company recently received FDA approval for BREXAFEMME (ibrexafungerp tablets) on June 1, 2021. The conference webcast will be accessible for three months on the SCYNEXIS website.
SCYNEXIS announced stock options grants for four new employees totaling 18,100 shares at an exercise price of $7.36, aligning with the closing price on June 30, 2021. The options, part of the 2015 Inducement Award Plan, vest over four years, promoting employee retention. This initiative aims to attract talent in the biotech sector, focusing on innovative antifungal treatments.
SCYNEXIS is advancing ibrexafungerp, a drug targeting drug-resistant fungal infections, with FDA approval for BREXAFEMME on June 1, 2021.
SCYNEXIS has announced an update for the commercial launch of BREXAFEMME (ibrexafungerp), the first FDA-approved antifungal in over 20 years, specifically for vaginal yeast infections. The launch call is set for June 29, 2021, at 12 PM ET, featuring key presentations from management and Dr. Michael L. Krychman. BREXAFEMME offers a new treatment option for vulvovaginal candidiasis (VVC) and is contraindicated during pregnancy. This innovative drug demonstrates a favorable safety profile and efficacy against various Candida strains. For more details, visit www.brexafemme.com.