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 (NASDAQ: SCYX) announced that the U.S. FDA granted QIDP and Fast Track designations for its second‑generation triterpenoid antifungal, SCY-247. The company noted QIDP will provide at least 10 years of post‑approval market exclusivity and Fast Track may enable more frequent FDA interaction, rolling review, and eligibility for accelerated approval or priority review. SCYNEXIS plans to initiate a Phase 1 IV study and a Phase 2 oral study in invasive candidiasis in 2026, and aims to release oral proof‑of‑concept data the same year. SCY-247 has shown preclinical activity against multi‑drug resistant fungi including Candida auris and azole‑resistant Aspergillus.
SCYNEXIS (NASDAQ: SCYX) received a 180-calendar-day extension from Nasdaq to regain compliance with the minimum bid price rule, extending the cure period to June 15, 2026.
Nasdaq confirmed SCYNEXIS meets other continued listing criteria and the company said it may use a reverse stock split if needed. Management also confirmed plans to complete a Phase 1 IV study and seek proof-of-concept Phase 2 oral data for investigational antifungal SCY-247 in invasive candidiasis, while maintaining commitments to regain full Nasdaq compliance.
SCYNEXIS (NASDAQ: SCYX) completed transfer of the BREXAFEMME (ibrexafungerp) NDA to GSK on November 19, 2025. GSK can now initiate regulatory interactions with the FDA to discuss a U.S. relaunch for vulvovaginal candidiasis (VVC) and refractory VVC (rVVC). Following a relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones plus royalties, which are payable net of amounts due to Merck and expected in the low- to mid-single digit percentage range. The company describes these payments as a potential source of future non-dilutive capital.
SCYNEXIS (NASDAQ: SCYX) announced it is a collaborator in a new Center of Excellence in Translational Research jointly led by Hackensack Meridian CDI and Johns Hopkins Bloomberg School of Public Health that received a federal five-year grant from NIAID.
The CETR expects to receive about $7 million annually, contingent on availability of funds, to support five projects including a novel series of SCYNEXIS’ proprietary triterpenoid antifungals (next‑generation fungerps) aimed to advance selected preclinical candidates toward IND readiness for resistant fungal infections.
SCYNEXIS (NASDAQ: SCYX) reported Q3 2025 results and a corporate update on Nov 5, 2025. The company will receive a one-time payment of $24.8 million from GSK related to termination of the Phase 3 MARIO study and expects a post-payment cash runway of greater than two years.
SCYNEXIS reported $37.9 million in cash, cash equivalents and investments as of Sept 30, 2025, net loss of $8.6 million (Q3 2025) and plans to start an IV Phase 1 for SCY-247 in Q1 2026 and a Phase 2 oral study with proof-of-concept data expected in 2026. GSK is pursuing a BREXAFEMME relaunch and SCYNEXIS may receive up to $146 million in annual net sales milestones plus low-to-mid single-digit royalties.
SCYNEXIS (NASDAQ:SCYX) resolved its disagreement with GSK over restarting the Phase 3 MARIO study on invasive candidiasis and will wind down and terminate MARIO.
As part of the resolution, SCYNEXIS will receive a $22.0 million payment plus an additional $2.3 million for wind-down activities. The company said the payment, combined with cash on hand and the removal of future MARIO expenses, extends its cash runway to more than two years. GSK reiterated its commitment to commercialize BREXAFEMME and to collaborate on transferring the BREXAFEMME NDA to GSK by end of 2025, with GSK planning FDA interactions in 2026 regarding relaunch in the U.S.
SCYNEXIS (NASDAQ: SCYX) reported positive Phase 1 trial results for SCY-247, its second-generation triterpenoid antifungal drug. The study evaluated single ascending doses (SAD) from 50mg to 900mg and multiple ascending doses (MAD) from 50mg to 300mg in healthy participants.
The trial demonstrated favorable safety and tolerability profiles, with no serious adverse events. Key findings include dose-proportional pharmacokinetics, rapid absorption (Tmax 3-7 hours), and achievement of target exposures at lower doses compared to their first-generation fungerp. The most common side effects were mild to moderate headache (16.7% SCY-247 vs 4.5% placebo) and diarrhea (9% in both groups).
SCYNEXIS (NASDAQ: SCYX) announced multiple presentations highlighting data for its second-generation fungerp drug candidate SCY-247 at the upcoming TIMM-12 Congress in Bilbao, Spain (September 19-22, 2025). The data demonstrates SCY-247's potent activity against difficult-to-treat fungal infections, particularly Candida auris, including strains resistant to current treatments.
The six presentations showcase SCY-247's broad-spectrum antifungal activity against various Candida species and Aspergillus species, including multidrug- and pandrug-resistant strains. Key findings include lower MICs for C. auris compared to echinocandins, effectiveness against 300 C. auris isolates from the New York area, and significant activity in mouse models of invasive candidiasis.
The company expects to report Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) trial results for oral SCY-247 in Q3 2025.
SCYNEXIS (NASDAQ: SCYX), a biotechnology company focused on developing treatments for drug-resistant infections, announced its participation in the upcoming H.C. Wainwright 27th Annual Global Conference. The company's senior leadership team will deliver an in-person presentation on September 10, 2025, from 10:30 AM to 11:00 AM ET in New York. One-on-one meetings with management will also be available through H.C. Wainwright representatives.
SCYNEXIS (NASDAQ: SCYX) reported Q2 2025 financial results and significant corporate developments. The company achieved a major milestone with the first patient dosed in the Phase 3 MARIO study after FDA's clinical hold lift, triggering a disputed $10M milestone payment from GSK, with an additional $20M milestone pending at the six-month mark.
Key financial metrics include Q2 2025 revenue of $1.4M, a net loss of $6.9M, and cash reserves of $46.5M providing runway into Q4 2026. R&D expenses increased 5% to $7.1M, while SG&A expenses rose 20% to $3.8M.
The company is working to transfer the BREXAFEMME NDA to GSK by end-2025 for potential 2026 relaunch. Additionally, SCYNEXIS expects to report Phase 1 SAD/MAD data for its second-generation fungerp candidate SCY-247 in Q3 2025.