STOCK TITAN

Scynexis (NASDAQ: SCYX) buys SCY-770 kidney drug for $8M upfront

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

SCYNEXIS, Inc. entered into an Asset Purchase Agreement with Poxel SA to acquire Poxel’s direct AMP kinase activator research program, including lead compound PXL-770, now SCY-770, for rare kidney disease ADPKD. SCYNEXIS will make a one-time upfront payment of $8,000,000 within 30 days of the agreement’s effective date and may pay up to $188,000,000 in development and commercial milestone payments tied to clinical progress and annual net sales thresholds.

The deal also includes an exclusive, sublicensable, perpetual worldwide license to related Poxel intellectual property. SCY-770 has been tested in eight clinical trials with a favorable safety profile and is planned to enter a Phase 2 proof-of-concept study in ADPKD in Q4 2026, with an early efficacy readout anticipated in the second half of 2027. SCY-770 holds FDA Orphan Drug Designation, while SCYNEXIS continues to develop its antifungal franchise, including potential BREXAFEMME milestones up to $146 million and ongoing Phase 1 work on SCY-247.

Positive

  • None.

Negative

  • None.

Insights

SCYNEXIS adds a late-preclinical/early-clinical rare kidney asset with sizable, milestone-based economics.

SCYNEXIS is expanding beyond antifungals by acquiring the AMP kinase activator program centered on SCY-770 for ADPKD. Economics are heavily back-end loaded: an upfront of $8,000,000 plus up to $188,000,000 in milestones tied to development and commercial success, which limits immediate cash outlay.

SCY-770 has prior clinical experience and Orphan Drug Designation, potentially supporting differentiated positioning in ADPKD, where the release cites Jynarque’s $1.5 billion U.S. sales in 2024 despite limited uptake. However, all milestone and sales scenarios remain contingent on successful Phase 2 and later-stage data.

The ADPKD Phase 2 proof-of-concept study is expected to begin in Q4 2026, with an early efficacy readout in the second half of 2027, defining key inflection points. Parallel progress of antifungal programs, including potential up to $146 million in annual net sales milestones from BREXAFEMME and ongoing SCY-247 development, provides diversification but also execution complexity across two therapeutic platforms.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 2.01 Completion of Acquisition or Disposition of Assets Financial
The company completed a significant acquisition or sale of business assets.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Upfront payment $8,000,000 One-time payment due within 30 days of Asset Purchase Agreement effective date
Total potential milestones $188,000,000 Aggregate development and commercial milestone payments tied to SCY-770 program
Phase 2 initiation milestone $2,000,000 Payable upon initiation of the first Phase 2 clinical trial
Phase 3 or first approval milestone $6,000,000 Triggered by first Phase 3 start or first U.S. marketing approval, whichever comes first
First U.S. commercial sale milestone $25,000,000 Due upon first commercial sale in the United States of a product containing an acquired compound
BREXAFEMME sales milestones Up to $146,000,000 Annual net sales milestone potential from GSK for licensed antifungal BREXAFEMME
Jynarque U.S. sales $1.5 billion 2024 U.S. sales for existing ADPKD therapy Jynarque cited as market benchmark
ADPKD U.S. prevalence 140,000 patients Estimated number of U.S. patients with Autosomal Dominant Polycystic Kidney Disease
Asset Purchase Agreement financial
"entered into an asset purchase agreement (the “Asset Purchase Agreement”)"
An asset purchase agreement is a legal contract in which a buyer agrees to buy specific assets and contracts of a business rather than buying the company’s stock or ownership. It matters to investors because it determines exactly what is being bought and what liabilities stay behind — like buying the furniture and equipment from a store but not the building or past debts — which affects the deal’s value, taxes and future risk exposure.
AMP-activated protein kinase (AMPK) medical
"a novel, highly selective, direct AMP-activated protein kinase (AMPK) activator"
Adenosine monophosphate–activated protein kinase (AMPK) is a cellular “energy sensor” enzyme that detects low energy and switches on processes that generate fuel while turning off energy-consuming tasks, much like a thermostat that adjusts heating when a room gets cold. It matters to investors because drugs or therapies that target AMPK can change how the body handles diabetes, obesity, heart disease and some cancers, affecting clinical trial prospects, regulatory approval paths and market value for companies developing such treatments.
Autosomal Dominant Polycystic Kidney Disease (ADPKD) medical
"for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)"
Orphan Drug Designation regulatory
"SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Phase 2 proof-of-concept study medical
"expected to begin a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026"
Qualified Infectious Disease Product (QIDP) regulatory
"SCY-247 has received QIDP, Fast Track and Orphan Drug designation from the FDA"
A qualified infectious disease product (QIDP) is a drug or antibiotic given a special regulatory label because it treats serious bacterial or fungal infections. The label brings incentives—such as faster regulatory review and extra time before generic competitors can enter—that make it easier and potentially more profitable for developers. Investors watch QIDP status because it can speed a product to market and extend exclusive sales, boosting revenue prospects.
SCYNEXIS INC NASDAQ false 0001178253 0001178253 2026-03-30 2026-03-30
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 30, 2026

 

 

SCYNEXIS, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-36365   56-2181648

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1 Evertrust Plaza

13th Floor

 
Jersey City, New Jersey   07302-6548
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: 201 884-5485

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001 per share   SCYX   The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 1.01 Entry into a Material Definitive Agreement.

Asset Purchase Agreement

On March 30, 2026, SCYNEXIS, Inc. (the “Company”) and Poxel SA, a French corporation (“Poxel”), entered into an asset purchase agreement (the “Asset Purchase Agreement”) pursuant to which the Company (i) acquired all of Poxel’s right, title and interest in Poxel’s direct AMP kinase activator research and development program assets, including all patents, know-how, regulatory filings, inventory, records, assumed contracts and other assets specifically related to compounds that directly activate AMP kinase, including the compound known as PXL-770 (collectively, the “Assets”); and (ii) assumed liabilities from Poxel related to the Assets arising after the effective date of the Asset Purchase Agreement (the “Transaction”).

Pursuant to the Asset Purchase Agreement, the Company will pay to Poxel a one-time upfront payment of $8,000,000 within thirty (30) days after the effective date of the Asset Purchase Agreement. In addition, the Company is obligated to pay Poxel milestone payments upon the first achievement of certain development and commercial milestone events related to products containing an acquired compound, for up to a total of $188,000,000 in aggregate milestone payments. The development and commercial milestone events are as follows:

 

Triggering event

   Milestone payment  

Initiation of the first phase 2 clinical trial

   $ 2,000,000  

Initiation of the first Phase 3 clinical trial, or first approval of a marketing authorization application in the United States, whichever comes first

   $ 6,000,000  

First commercial sale in the United States

   $ 25,000,000  

Calendar year net sales equal to or greater than $250,000,000

   $ 5,000,000  

Calendar year net sales equal to or greater than $500,000,000

   $ 25,000,000  

Calendar year net sales equal to or greater than $1,000,000,000

   $ 50,000,000  

Calendar year net sales equal to or greater than $1,500,000,000

   $ 75,000,000  
  

 

 

 

Total up to:

   $ 188,000,000  
  

 

 

 

In connection with the Transaction, Poxel also granted to the Company an exclusive, sublicensable, perpetual and irrevocable, worldwide license under certain licensed intellectual property controlled by Poxel to research, develop, manufacture, use, sell, offer for sale, import, commercialize and otherwise exploit compounds and products related to the AMP kinase activator program.

The Asset Purchase Agreement contains customary representations, warranties, covenants and indemnification provisions. Both Poxel and the Company have agreed to indemnify the other party for losses arising from certain breaches of the Asset Purchase Agreement and other specified liabilities. The indemnification provisions are subject to certain limitations with respect to recovery for losses.

The Asset Purchase Agreement is governed by the internal laws of the State of New York. Disputes are subject to escalation through executive negotiation, non-binding mediation and, ultimately, binding arbitration administered by the International Chamber of Commerce with the seat of arbitration in New York, New York.

 


The Asset Purchase Agreement is not intended to be a source of financial, business or operational information about the Company. The representations, warranties and covenants contained in the Asset Purchase Agreement were made only for the purposes of the Asset Purchase Agreement as of the dates specified therein and solely for the benefit of the parties to the Asset Purchase Agreement. In addition, the representations, warranties and covenants contained in the Asset Purchase Agreement may be subject to qualifications and limitations agreed upon by the parties in connection with negotiating the terms of the Asset Purchase Agreement, including being qualified by confidential disclosure schedules made for the purpose of allocating contractual risk among the parties as opposed to establishing such matters as facts, and may further be subject to certain standards of materiality applicable to the parties that differ from those applicable to investors. As a result, investors should not rely on the representations, warranties and covenants included in the Asset Purchase Agreement, or any descriptions thereof, as characterizations of the actual state of facts or condition of the Company and its business.

The foregoing description of the terms of the Asset Purchase is not complete and is qualified in its entirety by reference to the full text of the Asset Purchase Agreement, a copy of which the Company intends to file as an exhibit to its next Quarterly Report on Form 10-Q.

Item 2.01 Completion of Acquisition or Disposition of Assets.

The information contained above in Item 1.01 is hereby incorporated by reference into this Item 2.01.

Item 7.01 Regulation FD Disclosure.

On March 31, 2026, the Company issued a press release announcing the Transaction and that the Company will host a conference call on Tuesday, March 31, 2026, at 8:30 a.m. ET to discuss the Transaction and provide a corporate update. Dial-in information for the call is as follows: Telephone access is available by dialing domestic 1-877-704-4453 or international 201-389-0920 (Conference ID: 13759746). The call will be webcast live at: https://viavid.webcasts.com/starthere.jsp?ei=1756904&tp_key=96d0e091dd.

A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “could,” “expect,” “estimate,” “may,” “should, “will,” and “would” and similar expressions and the negatives of those terms. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this report. Examples of these forward-looking statements include, but are not limited to, statements concerning the payment(s) to be paid in connection with the Transaction, the anticipated benefits of the Transaction, the Company’s ability to successfully integrate the Assets into its existing operations, the expected development timeline and regulatory pathway for the Assets, the potential commercial opportunity for products containing acquired compounds, and the Company’s plans for research, development and commercialization of the AMP kinase activator program. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: the occurrence of any event, change or other circumstances that could give rise to the termination of the Asset Purchase Agreement; the risk that the Transaction disrupts current plans and operations as a result of the announcement and consummation of the Transaction; the Company’s ability to recognize the anticipated benefits of the Transaction; costs related to the Transaction, including potential milestone payment obligations; the possibility that the Company may be adversely affected by other economic, business and/or competitive factors; risks related to the protection, maintenance and enforcement of intellectual property rights associated with the Assets; the risk that preclinical and clinical data relating to the Assets


may not be predictive of future results; risks associated with the development and timing of the Company’s programs, including , which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval; the uncertainty of obtaining regulatory approvals for products containing acquired compounds; the competitive landscape for AMP kinase activators and related therapeutic areas; the Company’s ability to fund its operations and to raise additional capital as needed, including to fund the development and commercialization of the Assets and the other programs in its pipeline; and the impact of global economic uncertainty, rising inflation, rising interest rates or market disruptions on its business. These risks and uncertainties are more fully described under the heading “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K filed with the SEC on March 4, 2026, and its subsequent filings with the SEC from time to time. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements and, except as required by law, the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.   

Description

99.1    Press release of the Company dated March 31, 2026
104    Cover Page Interactive Data File (formatted as Inline XBRL)

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      SCYNEXIS, Inc.
Date: March 31, 2026     By:  

/s/ David Angulo, M.D.

    Name:   David Angulo, M.D.
    Its:   Chief Executive Officer

Exhibit 99.1

 

 

LOGO

SCYNEXIS Completes Transformative Acquisition of PXL-770, an innovative, highly selective, direct AMPK activator for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

 

   

PXL-770 (now SCY-770) is a clinical stage, well-characterized oral therapy designed to address the underlying drivers of ADPKD by reducing cyst growth and disease progression

 

   

A Phase 2 proof-of-concept study of SCY-770 in ADPKD patients is anticipated to begin in Q4 2026 with an early efficacy readout anticipated in the second half of 2027

 

   

With this acquisition, SCYNEXIS strengthens its mission to develop innovative solutions for severe and rare diseases, unlocking further opportunities for value creation

SCYNEXIS will host a conference call on March 31, 2026 at 8:30 a.m. ET to provide a corporate update.

JERSEY CITY, N.J., March 31, 2026 – SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company focused on developing innovative new therapies to address severe rare diseases, today announced that it has entered into a definitive agreement with Poxel S.A. (POXEL.PA) to acquire PXL-770 (now SCY-770).

SCY-770 is a novel, highly selective, direct AMP-activated protein kinase (AMPK) activator for the treatment of ADPKD, the leading genetic cause of end-stage renal failure. SCY-770 is designed to address many of the underlying drivers of ADPKD by reducing cyst growth and disease progression.

SCY-770 is an oral therapy that has been evaluated in eight clinical trials, with a favorable safety profile. SCYNEXIS is expected to begin a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026, with an anticipated early efficacy readout in second half of 2027. SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

“We are excited about this transformative asset acquisition, strengthening our pipeline, and dedicating our development expertise and resources to tackle severe and rare diseases,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-770 is supported by a strong pre-clinical data package and a novel differentiated MOA that targets multiple key drivers of ADPKD progression, positioning it as a promising candidate in a significant rare disease market with a high unmet need. Our near-term priority is to efficiently advance SCY-770 into a Phase 2 POC study later this year. We look forward to advancing the standard of care for patients with ADKPD.”


“ADPKD is a progressive disease characterized by the growth of kidney cysts that ultimately leads to end-stage kidney disease,” said Dr. Kenneth Hallows, MD, PhD, Nephrologist, System Division Chief, Nephrology Professor, Larner College of Medicine, University of Vermont Health. “Patients face a substantial lifelong burden, often requiring renal replacement therapy. Despite the significant unmet need, treatment options remain limited with only one approved therapy, which is associated with safety concerns and suboptimal tolerability. It is encouraging to see a new therapeutic candidate advancing in development, particularly one with a promising MOA that has the potential to deliver a meaningful clinical benefit to a broad population of patients in need.”

Terms of Acquisition Agreement

Under the terms of the asset acquisition agreement, SCYNEXIS will make an upfront payment of $8 million, with future potential payments of up to $8 million in development milestones, and up to $180 million in commercial milestones, of which $125 million is triggered by annual net sales at or above $1 billion.

Conference call and webcast details

SCYNEXIS will host a live conference call on Tuesday, March 31, 2026 at 8:30 am ET to provide a corporate update and discuss the asset acquisition.

Conference call details:

Date: Tuesday, March 31, 2026

Time: 8:30 AM ET

Dial in: U.S/Domestic: 1-877-704-4453 or International: 201-389-0920

Conference ID: 13759746

Interested parties may access the webcast by clicking here

About ADPKD

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disease caused by mutations of the PKD1 or PKD2 genes which encode polycystin complex 1 (PC1) or polycystin complex 2 (PC2) proteins, critical for normal tubular epithelial cell function. Patients develop fluid-filled cysts in their kidneys that progressively impair their kidney function with more than 50% reaching end-stage renal failure in their 60s requiring renal replacement therapies (e.g., dialysis or transplant). The U.S. prevalence of ADPKD is estimated to be 140,000 patients1, with approximately 6,000 new cases diagnosed each year2. ADPKD currently has only one approved therapy, Jynarque (tolvaptan), which achieved approximately $1.5 billion in U.S. sales in 2024 despite limited patient uptake due to safety, tolerability, and monitoring requirements.

About SCY-770

SCY-770 (formerly known as PXL-770), a novel and highly selective, direct AMP-activated protein kinase (AMPK) activator, is being developed as a disease-modifying therapy for ADPKD, a progressive genetic kidney disorder with significant unmet medical need. SCY-770 has been evaluated in several Phase 1 trials and one Phase 2a trial in patients with nonalcoholic fatty liver disease (NAFLD). Compelling preclinical pharmacology data supports its potential utility in ADPKD. The Company aims to develop SCY-770 with the goal of reducing cyst growth and disease progression and improving patient quality of life.

 
1 

Willey C, et.al. Analysis of Nationwide Data to Determine the Incidence and Diagnosed Prevalence of Autosomal Dominant Polycystic Kidney Disease in the USA: 2013-2015. Kidney Dis (Basel). 2019 Mar;5(2):107-117;

2 

Barnawi RA, et al. Is the light at the end of the tunnel nigh? A review of ADPKD burden of disease and tolvaptan as a new treatment. Int J Nephrol Renovasc Dis. 2018 Feb 1;11:53-67


About the Antifungal Business

The Company developed and obtained multiple FDA approvals for BREXAFEMME, the first representative of a new class of antifungals in more than 20 years, and has outlicensed it to GSK. SCYNEXIS has the potential to receive up to $146 million in annual net sales milestones plus net royalties in the low-to-mid-single digits for the commercialization of BREXAFEMME by GSK. The Company’s second-generation antifungal, SCY-247, is currently in a Phase 1 trial of the IV formulation, with data expected in Q3 2026. SCY-247 has received QIDP, Fast Track and Orphan Drug designation from the FDA. SCYNEXIS will continue to pursue non-dilutive funding opportunities to further support its development. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is dedicated to advancing innovative solutions for severe rare diseases. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247, currently in clinical stages of development. 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: Proof-of-concept Phase 2 study in ADPKD to begin in Q4 2026 with early efficacy readout anticipated in 2H 2027; the potential of SCY-770 to treat patients with ADPKD; the Company plans to continue its Phase 1 trial of the IV formulation of SCY-247 with data expected in Q3 2026; and receipt of future payments from GSK on sales of BREXAFEMME. 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 (the “SEC”), including without limitation, the section titled “Risk Factors” in its most recent Annual Report on Form 10-K filed on March 4, 2026, and in other filings the Company makes with the SEC from time to time. 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 asset did SCYNEXIS (SCYX) acquire from Poxel in this 8-K?

SCYNEXIS acquired Poxel’s direct AMP kinase activator research program, including lead compound PXL-770, now called SCY-770. The deal covers patents, know-how, regulatory filings, inventory, records, and related contracts targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD) and other AMP kinase activator opportunities.

How much is SCYNEXIS (SCYX) paying for the SCY-770 ADPKD program?

SCYNEXIS will pay a one-time upfront payment of $8 million within 30 days of the asset purchase agreement’s effective date. It may also pay up to $188 million in additional development and commercial milestone payments, linked to clinical trial initiation, approvals, first U.S. sales, and specified annual net sales tiers.

What future clinical plans does SCYNEXIS (SCYX) have for SCY-770?

SCYNEXIS expects to start a Phase 2 proof-of-concept study of SCY-770 in ADPKD patients in Q4 2026. An early efficacy readout is anticipated in the second half of 2027, making these key milestones for understanding SCY-770’s potential to slow cyst growth and disease progression.

Does SCY-770 have any special regulatory status mentioned by SCYNEXIS (SCYX)?

Yes. SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. This status can provide incentives such as market exclusivity upon approval, fee reductions, and development support, which may be advantageous for targeting the rare disease ADPKD population.

How does SCYNEXIS (SCYX) describe the ADPKD market opportunity?

ADPKD affects an estimated 140,000 patients in the U.S., with around 6,000 new cases annually, and currently has only one approved therapy. The press release notes that Jynarque (tolvaptan) generated about $1.5 billion in U.S. sales in 2024 despite limited uptake, highlighting significant unmet need.

What ongoing antifungal revenue opportunities does SCYNEXIS (SCYX) highlight?

SCYNEXIS notes that BREXAFEMME, its first approved antifungal from the fungerps class, is outlicensed to GSK. The company has potential to receive up to $146 million in annual net sales milestones plus low-to-mid single-digit net royalties, alongside continued development of its second-generation antifungal SCY-247.

Filing Exhibits & Attachments

4 documents