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

Key Figures

IV Phase 1 results timing: 2026 Oral SAD/MAD data timing: September 2025 FDA designations date: January 21, 2026

3 metrics

IV Phase 1 results timing 2026 Results from IV SCY-247 Phase 1 SAD/MAD trial expected

Oral SAD/MAD data timing September 2025 Positive oral SCY-247 Phase 1 SAD/MAD data announced

FDA designations date January 21, 2026 QIDP and Fast Track designations for SCY-247 announced

Market Reality Check

Price: $0.7100 Vol: Volume 747,994 is 2.04x t...

high vol

$0.7100 Last Close

Volume Volume 747,994 is 2.04x the 20-day average of 366,304, indicating elevated trading interest pre-announcement. high

Technical Trading below the 200-day MA of 0.77 with price at 0.71, reflecting a weak longer-term trend.

Peers on Argus

SCYX fell 9.77% while close peers showed mixed moves (e.g., IXHL -9.27%, CPIX +2...

SCYX fell 9.77% while close peers showed mixed moves (e.g., IXHL -9.27%, CPIX +2.5%, AYTU +2.67%), and no peers appeared in the momentum scanner, pointing to stock-specific factors.

Previous Clinical trial Reports

5 past events · Latest: Nov 19 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	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.

Pattern Detected

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.

Recent Company History

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.

Historical Comparison

-1.2% avg move · Over the last five clinical-trial-tagged events, SCYX moved an average of -1.24%. Today’s -9.77% rea...

clinical trial

-1.2%

Average Historical Move clinical trial

Over the last five clinical-trial-tagged events, SCYX moved an average of -1.24%. Today’s -9.77% reaction to the IV SCY-247 Phase 1 dosing headline is a notably larger downside move than past similar updates.

Clinical development has progressed from initiating oral SCY-247 Phase 1 in Dec 2024 to positive oral SAD/MAD results in Sep 2025. In parallel, SCYNEXIS resolved MARIO and transferred the BREXAFEMME NDA to GSK. The new IV SCY-247 Phase 1 SAD/MAD trial extends this trajectory into an additional formulation for invasive candidiasis and prophylaxis.

Market Pulse Summary

This announcement advances SCY-247 by starting an IV Phase 1 SAD/MAD trial, complementing prior posi...

Analysis

This announcement advances SCY-247 by starting an IV Phase 1 SAD/MAD trial, complementing prior positive oral Phase 1 data and recent FDA QIDP and Fast Track designations. It continues a multi-year shift toward next-generation antifungals following MARIO’s wind-down and the BREXAFEMME NDA transfer to GSK. Investors may monitor 2026 IV Phase 1 results, progress toward planned Phase 2 studies, and future partnership or non-dilutive funding updates as key milestones.

Key Terms

single ascending dose, multiple ascending dose, intravenous, triterpenoid, +3 more

7 terms

single ascending dose medical

"Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial"

A single ascending dose is a method used in testing new medicines where small amounts are given to participants, gradually increasing each time to find the safest and most effective dose. For investors, it provides important information about a drug’s safety and potential, helping gauge the progress and prospects of a pharmaceutical development.

multiple ascending dose medical

"Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

intravenous medical

"evaluating the intravenous formulation (IV) of its second-generation triterpenoid"

Intravenous means delivering a drug, fluid or substance directly into a vein so it goes straight into the bloodstream. For investors, that matters because intravenous products often act faster, require different manufacturing, regulatory steps and healthcare settings (like hospitals or clinics), and can affect pricing, adoption and revenue profiles in ways that differ from pills or topical treatments — like turning a slow-release delivery into a direct tap to the system.

triterpenoid medical

"second-generation triterpenoid antifungal therapy, SCY-247"

Triterpenoids are a broad family of naturally occurring chemical compounds formed by repeating a simple molecular unit, like building a structure from Lego blocks. They can influence biological processes and are studied for possible uses in medicines, skin products, and crop treatments, so news about them can signal potential new products, patent value, or clinical progress that affects a company’s future revenue and risk profile.

prophylaxis medical

"and as a prophylaxis therapy for invasive fungal disease"

Prophylaxis is a medical prevention strategy — a drug, vaccine, device, or procedure given to stop a disease or condition before it starts. For investors, prophylactic products matter because they can create steady, large markets and reduce long‑term healthcare costs; regulatory approval or broader adoption can change demand forecasts much like a new safety feature that becomes standard across an entire industry.

qualified infectious disease product regulatory

"grant SCY-247 both Qualified Infections Disease Product and Fast Track designations"

A qualified infectious disease product is a drug or biologic given a special regulatory label because it targets serious or life‑threatening infections and meets public‑health needs. The label brings incentives such as faster regulatory review, development tax benefits, and extra time with market exclusivity—think of it as a VIP pass and an extended storefront lease that can speed approval and delay generic competition. For investors, that can raise a candidate’s commercial value, lower development risk and make partnerships or buyouts more likely.

fast track regulatory

"grant SCY-247 both Qualified Infections Disease Product and Fast Track designations"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

AI-generated analysis. 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

FAQ

What did SCYNEXIS (SCYX) announce on February 26, 2026 about SCY-247?

SCYNEXIS announced dosing of the first participants in a Phase 1 IV SAD/MAD trial of SCY-247. According to the company, this advances an IV option for invasive candidiasis and aims to broaden treatment flexibility alongside prior oral data.

When are results from the SCY-247 intravenous Phase 1 trial expected for SCYNEXIS (SCYX)?

Results from the IV SAD/MAD trial are expected in 2026. According to the company, topline safety and PK data from the Phase 1 study will inform further development plans and dosing decisions.

What FDA designations has SCY-247 received for SCYNEXIS (SCYX) and what do they mean?

SCY-247 received QIDP and Fast Track designations from the FDA. According to the company, these designations may enable priority review and facilitate expedited development and regulatory interactions.

What did the September 2025 oral SCY-247 SAD/MAD data show for SCYNEXIS (SCYX)?

The oral SAD/MAD data showed excellent PK/PD and achieved target exposures at doses lower than first-generation drugs. According to the company, this may offer tolerability advantages for invasive fungal disease dosing.

How could an IV formulation of SCY-247 impact treatment for invasive candidiasis (SCYX)?

An IV formulation could provide additional treatment flexibility for hospitalized patients with invasive candidiasis. According to the company, IV dosing could complement oral therapy for severe or hard-to-treat fungal infections.