SCYNEXIS announces dosing of participants in Phase 1 trial for SCY-247, its intravenous antifungal therapy for invasive candidiasis.
Quiver AI Summary
SCYNEXIS, Inc. announced that the first participants have been dosed in a Phase 1 clinical trial evaluating the intravenous formulation of their antifungal therapy, SCY-247, aimed at treating invasive candidiasis and providing prophylaxis for invasive fungal diseases. This milestone follows SCY-247 receiving Qualified Infectious Disease Product and Fast Track designations from the FDA. The trial will assess both single ascending and multiple ascending doses, with results expected later in 2026. SCYNEXIS previously reported promising data for the oral formulation of SCY-247, highlighting its pharmacokinetic and pharmacodynamic advantages. The company continues to seek non-dilutive funding to advance the SCY-247 program amid rising antifungal resistance challenges.
Potential Positives
- SCYNEXIS has successfully dosed the first participants in a Phase 1 trial for the intravenous formulation of SCY-247, marking a significant milestone in the development of a new antifungal therapy.
- The intravenous formulation of SCY-247 is expected to provide additional flexibility for managing patients with invasive candidiasis, potentially improving treatment outcomes.
- SCY-247 has received both Qualified Infectious Disease Product and Fast Track designations from the FDA, which may expedite its development and regulatory approval process.
- The company has previously announced positive data for the oral formulation of SCY-247, indicating strong pharmacokinetic and pharmacodynamic properties that may offer distinct advantages over existing treatments.
Potential Negatives
- The announcement of the Phase 1 trial's expected results in 2026 indicates a lengthy timeline, potentially leading to investor concern over delays in product development and market entry.
- While the press release mentions positive data for the oral formulation of SCY-247, it does not provide any data or results for the IV formulation, which may raise questions about its efficacy and development status.
- The emphasis on seeking non-dilutive funding opportunities may signal financial constraints or a lack of sufficient capital for the clinical development of SCY-247.
FAQ
What is SCY-247 developed for?
SCY-247 is developed as a treatment for invasive candidiasis and as a prophylactic therapy for invasive fungal disease.
What trial is SCY-247 currently undergoing?
SCY-247 is currently undergoing a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial.
What designations has SCY-247 received from the FDA?
SCY-247 has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
When are results from the SCY-247 trial expected?
Results from the SCY-247 trial are expected in 2026.
What advantages does the IV formulation of SCY-247 offer?
The IV formulation of SCY-247 provides additional flexibility for optimal management of patients with invasive candidiasis.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SCYX Hedge Fund Activity
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$SCYX Analyst Ratings
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Full Release
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
[email protected]