SCYNEXIS, Inc. - SCYX STOCK NEWS

SCYNEXIS, Inc. has announced an extension of BREXAFEMME's exclusivity under the GAIN Act for a total of 10 years. The FDA's decision to grant 5 years of exclusivity is an addition to existing new chemical entity exclusivity. Moreover, BREXAFEMME is protected by a composition-of-matter patent, which is expected to last until 2035. The company plans to discuss commercial launch strategies on June 29. This antifungal drug is crucial for treating vulvovaginal candidiasis, especially against resistant strains of Candida.

SCYNEXIS, Inc. announced FDA approval for BREXAFEMME (ibrexafungerp), the first drug in a new antifungal class in over 20 years, specifically for treating vulvovaginal candidiasis (VVC). Following positive results from two Phase 3 studies, this oral treatment offers a favorable tolerability profile and is expected to launch commercially in partnership with Amplity Health in the latter half of 2021. With 14 years of patent protection, SCYNEXIS aims to establish a robust antifungal franchise, addressing the growing need for effective treatments against drug-resistant fungal infections.

SCYNEXIS (NASDAQ: SCYX) announced significant corporate developments and financial results for Q1 2021. The company secured approximately $35 million in non-dilutive funding, enhancing its cash runway into 2023. They anticipate FDA approval for ibrexafungerp (Brexafemme) to treat vaginal yeast infections by June 1, 2021. Phase 1 trial dosing for an IV formulation is underway. Q1 net loss decreased to $4.7 million from $7.0 million year-over-year. Selling, general & administrative expenses rose significantly, while research expenses decreased by 30%.

SCYNEXIS, Inc. (NASDAQ: SCYX) secured a $60 million term loan from Hercules Capital and Silicon Valley Bank to enhance its financial position ahead of the anticipated June 1 FDA approval for ibrexafungerp, an oral antifungal for vaginal yeast infections. This non-dilutive funding, along with a $93 million cash balance and other capital injections, extends SCYNEXIS’ cash runway into 2023. The loan disburses in four tranches, with $20 million already received and $10 million contingent upon FDA approval. This funding will support the launch of Brexafemme and the ongoing development of its antifungal pipeline.

SCYNEXIS, Inc. announced the appointment of Christine Coyne as Chief Commercial Officer, effective May 10, 2021. With over 30 years of experience in product commercialization, Coyne is expected to lead the upcoming U.S. launch of Brexafemme (ibrexafungerp), an oral antifungal for treating vulvovaginal candidiasis, pending FDA approval by June 1, 2021. The company aims to leverage her expertise in anti-infectives as they seek to broaden the product's label for treating severe infections.

SCYNEXIS (NASDAQ: SCYX) announced positive clinical outcomes for ibrexafungerp (Brexafemme) in treating vulvovaginal candidiasis (VVC), particularly in patients with non-albicans Candida and severe VVC. Data from two Phase 3 studies (VANISH-303 and VANISH-306) demonstrated its potential efficacy, with clinical cure rates of 42.1% for non-albicans and 63.3% overall after 10 days. Currently under FDA review, with a target decision date of June 1, 2021, ibrexafungerp could fulfill a significant unmet need for effective oral antifungal options.

SCYNEXIS (NASDAQ: SCYX) announced that two data sets from its Phase 3 VANISH Program on ibrexafungerp for vulvovaginal candidiasis (VVC) have been accepted for poster presentations at the ACOG Annual Meeting from April 30 to May 2, 2021. Brexafemme, the trade name for ibrexafungerp, is under FDA review with a PDUFA date set for June 1, 2021. The posters will feature studies on non-albicans Candida species and the efficacy and safety of the treatment. If approved, Brexafemme will be the first novel antifungal class in over 20 years, addressing an urgent need in VVC treatment.

SCYNEXIS has announced significant developments, including the FDA's acceptance of the New Drug Application (NDA) for oral ibrexafungerp, now branded as Brexafemme, for vaginal yeast infections, with a target action date of June 1, 2021. The company partnered with Amplity Health for commercialization and secured a $10 million upfront payment from Hansoh Pharma for rights in Greater China, potentially leading to $112 million more in payments. SCYNEXIS also disclosed positive interim Phase 3 study results for ibrexafungerp, showing efficacy against severe fungal infections and a strong cash position into 2023.

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.