SCYNEXIS Announces First Participants Dosed in a Phase 1 Single Ascending Dose and Multiple Ascending Dose Trial of Intravenous SCY-247
Rhea-AI Summary
SCYNEXIS (NASDAQ: SCYX) announced dosing of first participants in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of intravenous SCY-247 for invasive candidiasis and prophylaxis against invasive fungal disease. FDA QIDP and Fast Track designations were previously granted. Results from the IV trial are expected in 2026. The company noted positive SAD/MAD oral SCY-247 data in September 2025 showing target exposures at lower doses and is exploring non-dilutive funding to support the program.
Positive
- First participants dosed in Phase 1 IV SAD/MAD trial
- FDA granted QIDP and Fast Track designations for SCY-247
- Oral SCY-247 showed target exposures at lower doses in Sept 2025
Negative
- Phase 1 IV trial results pending; data expected in 2026
News Market Reaction – SCYX
In the Feb 26 session, SCYX declined 0.70%, reflecting a mild negative market reaction. Argus tracked a peak move of +2.6% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 19 | NDA transfer to GSK | Positive | +1.8% | Completed transfer of BREXAFEMME NDA to GSK with milestone potential. |
| Oct 15 | MARIO dispute resolution | Positive | -0.3% | Resolved MARIO dispute with GSK and secured cash payments, extending runway. |
| Sep 30 | Positive Phase 1 data | Positive | -26.7% | Reported favorable safety and PK from oral SCY-247 Phase 1 SAD/MAD study. |
| May 28 | Phase 3 MARIO resumed | Positive | +28.0% | Resumed MARIO Phase 3 dosing after FDA lifted clinical hold on ibrexafungerp. |
| Dec 18 | Phase 1 initiation | Positive | -9.0% | Initiated dosing in first Phase 1 trial of SCY-247 for invasive infections. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical and development milestones for SCYNEXIS often produce mixed reactions; several positive clinical-trial updates have seen negative or muted next-day moves, with only some events aligning positively with the news tone.
Over the past year, SCYNEXIS has advanced multiple clinical and partnership milestones. It initiated oral SCY-247 Phase 1 dosing on Dec 18, 2024, then reported positive SAD/MAD results on Sep 30, 2025. The company resumed, then later wound down, the Phase 3 MARIO study while securing milestone payments from GSK. It also completed transfer of the BREXAFEMME NDA to GSK on Nov 19, 2025. Today’s IV SCY-247 Phase 1 dosing continues the shift toward new-generation antifungals.
Key Terms
single ascending dose medical
multiple ascending dose medical
intravenous medical
triterpenoid medical
invasive candidiasis medical
prophylaxis medical
qualified infectious disease product regulatory
fast track regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Results from IV Phase 1 SAD/MAD Trial Expected in 2026
JERSEY CITY, N.J., Feb. 26, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial evaluating the intravenous formulation (IV) of its second-generation triterpenoid antifungal therapy, SCY-247, which is being developed as a treatment for invasive candidiasis (IC) and as a prophylaxis therapy for invasive fungal disease. Results from this trial are expected in 2026.
“Following the FDA’s recent decision to grant SCY-247 both Qualified Infections Disease Product and Fast Track designations, we are pleased to announce the dosing of the first cohort of participants in our Phase 1 SAD/MAD trial of IV SCY-247,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “An IV formulation of SCY-247 would provide additional flexibility for the optimal management of patients with invasive candidiasis and we are excited by the achievement of this important development milestone, which moves this innovative antifungal closer towards meeting the needs of patients suffering from difficult to treat severe fungal diseases."
In September 2025, the Company announced positive SAD/MAD data for the oral formulation of SCY-247, demonstrating its excellent pharmacokinetic and pharmacodynamic properties. Oral SCY-247 also achieved target exposures for invasive fungal disease at doses lower than first generation fungerps, which may confer distinct tolerability advantages. Based on its differentiated attributes and its potential role to counter health security threats posed by the continuous rise of antifungal resistance, SCYNEXIS continues to explore potential non-dilutive funding opportunities to further support the SCY-247 program.
On January 21, 2026, the Company announced that the U.S. Food and Drug Administration (FDA) granted SCY-247 both Qualified Infectious Disease Product (QIDP) and Fast Track designations.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. The second generation fungerp SCY-247 is currently in clinical stages of development and has received QIDP and Fast Track designation from the FDA. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: the results from the IV Phase 1 SAD/MAD trial expected in 2026; the benefits of an IV formulation and the potential for SCY-247 to meet the needs of patients; SCY-247 having the potential to significantly reduce fungal burden compared to other available antifungal therapies, including the azoles and echinocandins; and SCY-247’s potential role to counter health security threats posed by antifungal resistance development. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com
