Scynexis Stock Price, News & Analysis

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.

SCYNEXIS (NASDAQ: SCYX) has resumed patient dosing in its Phase 3 MARIO study, investigating oral ibrexafungerp as a step-down therapy for invasive candidiasis following IV echinocandin treatment. The study's resumption follows the FDA's lifting of a clinical hold related to manufacturing site concerns. The trial has already enrolled approximately 25% of projected patients.

The dosing resumption triggers a disputed $10 million milestone payment from GSK, with an additional $20 million milestone due in six months. GSK contests these payments, and SCYNEXIS disagrees with their position. If successful, the study could provide healthcare providers with a non-azole oral therapy option that maintains the mechanism of action of IV-only echinocandins, considered the gold standard for treating invasive Candida infections.

SCYNEXIS (NASDAQ: SCYX) reported Q1 2025 financial results and key developments. The FDA lifted the clinical hold on ibrexafungerp, but SCYNEXIS faces a disagreement with GSK regarding the restart of the Phase 3 MARIO study for invasive candidiasis treatment. GSK maintains commitment to Brexafemme commercialization. In China, Hansoh received NMPA approval for ibrexafungerp in acute VVC treatment, triggering future milestone payments and ~10% royalties. The company presented positive preclinical data for SCY-247, its second-generation fungerp candidate, with Phase 1 results expected in Q3 2025. Financial highlights include: Q1 net loss of $5.4 million ($0.11 per share), revenue of $0.3 million, and cash position of $53.8 million providing runway into Q3 2026.

SCYNEXIS (NASDAQ: SCYX) announced the presentation of preclinical efficacy data for its second-generation fungerp candidate SCY-247 at ESCMID Global 2025 in Vienna. The research, presented through four distinct posters, demonstrates SCY-247's effectiveness against difficult-to-treat fungal infections.

Key findings include SCY-247's potent antifungal activity against 171 clinical yeast isolates, and its effectiveness against 161 Spanish antifungal-resistant Candida species. The drug showed particular promise against Candida auris, maintaining robust activity against both wild-type and echinocandin-resistant strains across 5 different clades. Additionally, testing against 537 fungemia yeast isolates demonstrated strong in vitro activity against clinical Candida species.

SCYNEXIS (NASDAQ: SCYX) reported its full year 2024 financial results, highlighting key developments in its antifungal pipeline. The company's Phase 1 trial of SCY-247, initiated in December 2024, is progressing with results expected in Q3 2025. The company reported a net loss of $21.3 million ($0.44 per basic share) for 2024, compared to a net income of $67.0 million in 2023.

Financial highlights include revenue of $3.7 million from the GSK license agreement and a $10 million milestone payment from GSK. R&D expenses decreased by 14.6% to $26.4 million, while SG&A expenses reduced by 30.9% to $14.5 million. The company ended 2024 with cash, cash equivalents and investments of $75.1 million, projecting runway into Q3 2026.

SCYNEXIS anticipates restarting its Phase 3 MARIO study in invasive candidiasis in Q2 2025, pending FDA's lifting of the clinical hold.