Scynexis Stock Price, News & Analysis

SCYNEXIS, Inc. (NASDAQ: SCYX) has signed an exclusive licensing agreement with GSK for Brexafemme (ibrexafungerp tablets), an FDA-approved antifungal for vulvovaginal candidiasis (VVC). The deal includes a $90 million upfront payment, potential milestone payments of $503 million, and tiered royalties. GSK will commercialize Brexafemme while SCYNEXIS retains rights to assets derived from enfumafungin. The agreement enhances GSK's infectious disease portfolio, focusing on addressing antimicrobial resistance and improving treatment options for patients, especially those suffering from recurrent infections.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced the FDA approval of BREXAFEMME (ibrexafungerp), the first non-azole oral therapy for treating vulvovaginal candidiasis (VVC) and reducing recurrent VVC incidence. Approval was based on the Phase 3 CANDLE study, showing ibrexafungerp's clinical success at 65.4% versus 53.1% for placebo (p=0.02). BREXAFEMME is aimed at empowering patients with recurrent infections and is positioned for commercialization in the U.S.

SCYNEXIS announced that researchers at Case Western Reserve University have received over $3 million from the NIH to study SCY-247, an antifungal targeting Candida auris, a multidrug-resistant pathogen. This five-year grant will evaluate the efficacy of SCY-247, a second-generation fungerp, in treating serious infections. C. auris has a high mortality rate and limited treatment options, prompting the need for new therapies. SCY-247 is under early development but shows promise in combating drug resistance.

SCYNEXIS, Inc. announces its antifungal drug, ibrexafungerp, aligns with BARDA's new initiative to develop broad-spectrum antifungal agents targeting drug-resistant fungi like Candida and Aspergillus. This follows BARDA's focus on innovative treatments amid rising fungal threats, highlighted by the WHO's recent report on dangerous pathogens. Ibrexafungerp has shown effectiveness against resistant strains and is in late-stage trials with FDA support. SCYNEXIS aims to address severe fungal infections, enhancing treatment options for patients.

SCYNEXIS is refocusing on ibrexafungerp for severe hospital-based indications. Ivor Macleod joins as CFO, while Marco Taglietti retires as CEO, with David Angulo stepping in from January 1, 2023. In Q3 2022, BREXAFEMME generated net revenues of $1.6 million, a 13% increase from Q2 2022. Coverage rose to 130 million lives, or 70% of commercially insured lives. The company has $96.1 million in cash, ensuring a runway into Q2 2024, and is pursuing commercialization partnerships for BREXAFEMME.

SCYNEXIS, Inc. has published a review highlighting the antifungal ibrexafungerp's potential against deadly fungal infections listed by the WHO. This novel treatment shows promise for immunocompromised patients facing invasive mold infections. Ibrexafungerp is noted for its effectiveness against drug-resistant species and its convenient oral dosing. Ongoing clinical trials aim to further validate its efficacy in treating mold infections. The widespread resistance to current antifungal treatments underscores the urgent need for novel therapies like ibrexafungerp.

SCYNEXIS announced positive results from a pooled analysis of two Phase 3 studies, VANISH-303 and VANISH-306, published in the Journal of Women’s Health. Ibrexafungerp demonstrated statistically significant superior clinical cure rates, complete symptom resolution, and mycological cure compared to placebo (p < 0.0001). The data supports its potential as an effective treatment for vulvovaginal candidiasis (VVC), indicating consistent efficacy across various patient sub-populations. Ibrexafungerp is well-tolerated with mild gastrointestinal adverse events.

SCYNEXIS, Inc. (NASDAQ: SCYX) has scheduled a conference call for November 9, 2022, at 8:30 a.m. EDT to discuss its third-quarter financial results for the period ending September 30, 2022. The company, focused on developing innovative medicines for drug-resistant infections, has received FDA approval for its antifungal product, BREXAFEMME, and filed a supplemental New Drug Application for expanded indications, with a target FDA action date of November 30, 2022. The call will also provide corporate updates and insights into ongoing clinical trials.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced the appointment of Ivor Macleod as Chief Financial Officer, bringing over 30 years of biopharma experience. Macleod will support the company's strategic shift towards hospital-based antifungal treatments, specifically ibrexafungerp, a first-in-class antifungal agent. He previously served as CFO at Athersys, Inc. and Eisai Inc. In connection with his appointment, he received stock options for 170,000 shares at $2.22 and 15,000 RSUs. The company also aims to expand BREXAFEMME's labeling to prevent recurrent vulvovaginal candidiasis, with a PDUFA date set for November 30, 2022.