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. develops therapies for severe rare diseases and difficult-to-treat fungal infections. The company’s updates center on SCY-770, a clinical-stage oral direct AMPK activator for autosomal dominant polycystic kidney disease, and SCY-247, a second-generation triterpenoid antifungal therapy in development for invasive candidiasis and prophylaxis of invasive fungal disease.
SCYNEXIS news also covers its fungerp antifungal platform, FDA designations for SCY-247, scientific presentations, financial results, and corporate actions. The company has licensed ibrexafungerp, including BREXAFEMME® for vulvovaginal candidiasis and reduction in recurrent vulvovaginal candidiasis, to GSK, making collaboration and license-agreement updates a recurring disclosure theme.
SCYNEXIS has entered a strategic partnership with Hansoh Pharmaceutical for ibrexafungerp, a broad-spectrum antifungal. Under this licensing agreement, SCYNEXIS will receive $122 million, including a $10 million upfront payment and low double-digit royalties. The collaboration enhances SCYNEXIS's cash runway into 2023 and preserves its commercial rights outside Greater China. Ibrexafungerp, currently pending FDA review for vaginal yeast infections, aims to address the rising antifungal resistance, showcasing its potential in combating serious fungal infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) announced the closing of its public offering of common stock, pre-funded warrants, and warrants, raising total gross proceeds of $85 million. The offering price was set at $6.25 per share and $6.249 per pre-funded warrant. In total, 8,340,000 shares of common stock and 5,260,000 pre-funded warrants were issued, along with warrants for 13,600,000 additional shares. The exercise price for the Series 1 and Series 2 warrants is $7.33 and $8.25 respectively. The funds raised are intended for advancing the company's clinical programs and general corporate purposes.
SCYNEXIS, Inc. (NASDAQ: SCYX) has priced its public offering of common stock, pre-funded warrants, and warrants at $6.25 per share, aiming for gross proceeds of approximately $85 million. The offering includes 8,390,000 shares and 5,210,000 pre-funded warrants, along with two series of warrants for an aggregate of 13,600,000 shares. The Series 1 warrants have a one-year term with an exercise price of $7.33, while Series 2 warrants have a three-and-a-half-year term at $8.25. This follows a shelf registration filed with the SEC in September 2020.
SCYNEXIS, Inc. (NASDAQ: SCYX) has announced a public offering of shares and warrants for its common stock. The offering, managed by Guggenheim Securities, LLC and Cantor Fitzgerald & Co., is contingent on market conditions. The company will sell all shares and warrants, with pre-funded warrants available for specific purchasers. A shelf registration statement was filed with the SEC on September 11, 2020. The final offering terms will be detailed in a prospectus supplement. SCYNEXIS focuses on innovating treatments for drug-resistant infections.
SCYNEXIS has announced approval from health authorities to initiate Phase 1 trials for the intravenous formulation of ibrexafungerp, targeting dosing in healthy volunteers by Q1 2021. Additionally, a new interim analysis of the ongoing Phase 3 studies (FURI and CARES) is set for the same timeframe, with an increase in the patient dataset from 41 to 84. This analysis will yield the first clinical trial data against Candida auris, a multidrug-resistant fungus. Ibrexafungerp is positioned to be the first new antifungal class in over 20 years, with both IV and oral formulations planned.
SCYNEXIS, Inc. has received Priority Review status from the FDA for its New Drug Application (NDA) for ibrexafungerp, aimed at treating vulvovaginal candidiasis (VVC). The PDUFA target action date is set for June 1, 2021. The FDA will not hold an advisory committee meeting for this application. Supported by two positive Phase 3 studies, ibrexafungerp could change the antifungal treatment landscape, potentially capturing a significant share of the market, estimated at over 16 million prescriptions annually.
SCYNEXIS, a biotechnology firm focused on innovative medicines for drug-resistant infections, announced its participation in key healthcare conferences. The Piper Sandler 32nd Annual Virtual Healthcare Conference runs from November 23 to December 3, 2020, allowing registered attendees to access presentations from 8:00 a.m. to 5:00 p.m. ET. Additionally, SCYNEXIS will join a panel discussion at Evercore ISI’s HealthCONx Conference on December 2, 2020, from 11:20 a.m. to 12:05 p.m. ET, addressing critical fungal infection needs. Webcast recordings will be available on their website for 30 days.
SCYNEXIS submitted a New Drug Application (NDA) for ibrexafungerp, targeting vulvovaginal candidiasis (VVC), with approval expected in mid-2021. The company estimates over 15 million antifungal prescriptions for VVC annually. Enrollment continues in the Phase 3 CANDLE study, alongside studies for serious fungal infections. Financially, SCYNEXIS reported a net income of $0.9 million for Q3 2020, a significant recovery from a net loss of $7.9 million in Q3 2019. Cash and equivalents totaled $29.5 million as of September 30, 2020.
SCYNEXIS, a biotechnology company, announced the presentation of three posters on ibrexafungerp, a novel antifungal drug, at IDWeek 2020, held virtually from October 21-25, 2020. The posters highlight clinical and preclinical data showcasing ibrexafungerp's effectiveness against serious fungal infections, which claim over a million lives annually. On October 14, SCYNEXIS submitted a New Drug Application to the FDA for ibrexafungerp's use in treating vulvovaginal candidiasis, with a decision expected by mid-2021.
SCYNEXIS has submitted a New Drug Application (NDA) to the FDA for ibrexafungerp, intended to treat vulvovaginal candidiasis (VVC). This submission is backed by positive data from two Phase 3 studies demonstrating superiority over placebo. If accepted, the NDA could undergo a 6-month priority review due to its Qualified Infectious Disease Product status. With the vaginal yeast infection market expanding, SCYNEXIS aims to address unmet needs in treatment options. The company anticipates notification on NDA acceptance by December 2020.