Scynexis Stock Price, News & Analysis

SCYNEXIS announced positive results from the Phase 3 FURI and CARES studies assessing oral ibrexafungerp for severe fungal infections. The FURI study indicated a clinical benefit in 86.5% of patients treated, while the CARES study showed an 80% complete response rate in patients with Candida auris. Both studies support ongoing patient enrollment and potential NDA submissions via the LPAD regulatory pathway. Ibrexafungerp has a positive safety profile, with gastrointestinal issues as the most common side effects.

On February 25, 2021, SCYNEXIS (NASDAQ: SCYX) announced that CEO Marco Taglietti will speak at Maxim Group's Late Stage Innovations in Women's Health event, scheduled for March 4, 2021, at 11:00 AM ET. Taglietti will provide insights on Brexafemme, an oral antifungal candidate currently under FDA review for treating vaginal yeast infections, with a PDUFA action date set for June 1, 2021. This highlights SCYNEXIS's commitment to addressing drug-resistant infections through innovative therapies.

SCYNEXIS has partnered with Amplity Health to enhance the commercial launch of Brexafemme, an antifungal treatment for vaginal yeast infections, which is set for FDA review with a PDUFA date of June 1, 2021. This partnership will utilize Amplity's sales capabilities while deferring some commercialization costs for the first two years. Brexafemme, an innovative oral treatment, aims to address the unmet needs in women's health, particularly as existing treatments may not be effective for many patients. SCYNEXIS is well-positioned financially, with a cash runway into 2023.

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.