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Evommune (NYSE: EVMN) halts EVO756 CSU program after Phase 2b miss

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(Neutral)
Form Type
424B3

Rhea-AI Filing Summary

Evommune, Inc. furnished a Form 8-K and prospectus supplement reporting top-line results from the randomized, double-blind, placebo-controlled Phase 2b trial of oral MRGPRX2 antagonist EVO756 in adults with moderate-to-severe chronic spontaneous urticaria (CSU). The trial enrolled 160 antihistamine-refractory CSU patients across the United States, Europe, Canada and Japan and tested three active dose regimens versus placebo.

The study did not meet its primary endpoint of mean change in Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose. Based on these results, the company plans to cease development of EVO756 for CSU while continuing to evaluate the compound in other indications. The press release was issued and furnished as Exhibit 99.1 on June 29, 2026.

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Insights

Phase 2b failed to meet the prespecified primary endpoint for CSU.

The randomized, double-blind, placebo-controlled Phase 2b trial of EVO756 enrolled 160 antihistamine-refractory CSU patients and measured mean change in UAS7 at 12 weeks as the primary endpoint. The filing states the study did not meet that endpoint at any tested dose.

The company cites these topline results and plans to cease development of EVO756 for CSU; further evaluation in other indications is described as ongoing. Subsequent clinical details, subgroup data, or predefined secondary endpoint outcomes are not disclosed in this excerpt.

Top-line failure in a Phase 2b CSU program is a material clinical setback for the program.

The prospectus supplement and 8-K confirm the company will stop CSU development for EVO756 after the Phase 2b readout. The filing notes enrollment across multiple regions and three dose regimens but provides no efficacy metrics, safety profile details, or impact on cash runway.

Financial and strategic consequences depend on undisclosed items such as safety data, secondary endpoints, any biomarker subsets, and costs already incurred; the filing does not quantify these factors or state cash‑flow effects.

Trial enrollment 160 patients Phase 2b moderate-to-severe antihistamine-refractory CSU trial
Primary endpoint UAS7 mean change at 12 weeks Did not meet at any dose
Last reported share price $25.18 per share Last reported sale price on June 26, 2026
Press release date June 29, 2026 Exhibit 99.1 furnished with Form 8-K
UAS7 medical
"primary endpoint of mean change in a patient's Urticaria Activity Score over seven days (UAS7) at 12 weeks"
UAS7 is a standardized clinical score that sums a patient’s daily ratings of hive number and itch severity over seven days to quantify how active chronic hives are. Investors care because it’s a widely accepted measure used in clinical trials to show whether a treatment meaningfully reduces symptoms; like a thermometer for patient improvement, stronger UAS7 results can influence regulatory approval chances and commercial prospects.
MRGPRX2 antagonist medical
"oral MRGPRX2 antagonist, EVO756, in adults with moderate-to-severe chronic spontaneous urticaria"
A mrgprx2 antagonist is a drug or compound that blocks the MRGPRX2 receptor on certain immune cells, stopping those cells from releasing histamine and other chemicals that trigger itch, swelling and pseudo‑allergic reactions. For investors, it represents a potential new approach to treat conditions like chronic itch, hives and some drug‑induced reactions; a successful antagonist could create new market opportunities, lower side‑effect risks and drive value through clinical and regulatory milestones.
Phase 2b clinical
"randomized, double-blind, placebo controlled, dose-ranging Phase 2b trial"
Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What did Evommune (EVMN) report about EVO756 in the June 29, 2026 filing?

Evommune reported top-line Phase 2b results showing EVO756 did not meet the primary endpoint. The company stated the trial failed to show improvement in mean UAS7 at 12 weeks and furnished a press release as Exhibit 99.1.

How many patients were enrolled in the EVO756 Phase 2b CSU trial?

The Phase 2b trial enrolled 160 moderate-to-severe, antihistamine-refractory CSU patients. Patients were enrolled across the United States, Europe, Canada and Japan and received one of three active dose regimens or placebo.

What is Evommune's plan for EVO756 after the Phase 2b results?

Evommune plans to cease development of EVO756 for CSU based on the Phase 2b topline results. The company also states it will continue to evaluate EVO756 in additional indications.

Did the filing disclose safety results or secondary endpoint data for EVO756?

No; the excerpt furnishes only topline efficacy information and the decision to cease CSU development. Detailed safety findings and secondary endpoint results are not provided in the supplied text.

Where can I find the company’s press release mentioned in the filing?

The filing furnishes the press release as Exhibit 99.1, dated June 29, 2026, titled "Evommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Chronic Spontaneous Urticaria."

Prospectus Supplement

Filed Pursuant to Rule 424(b)(3)

(to Prospectus dated April 24, 2026)

Registration No. 333-295140

img189847932_0.jpg

This prospectus supplement updates, amends and supplements the prospectus dated April 24, 2026 (the “Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration No. 333-295140). Capitalized terms used in this prospectus supplement and not otherwise defined herein have the meanings specified in the Prospectus.

This prospectus supplement is being filed to update, amend and supplement the information included in the Prospectus with the information contained in our Current Report on Form 8-K filed with the Securities and Exchange Commission on June 29, 2026, which is set forth below.

This prospectus supplement is not complete without the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus, including and supplements and amendments thereto, which is to be delivered with this prospectus supplement, and is qualified by reference thereto, except to the extent that the information in this prospectus supplement updates or supersedes the information contained in the Prospectus. Please keep this prospectus supplement with your Prospectus for future reference.

Our common stock is traded on the New York Stock Exchange under the symbol “EVMN.” On June 26, 2026, the last reported sale price of our common stock was $25.18 per share.

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section titled “Risk Factors” beginning on page 5 of the Prospectus, and under similar headings in any amendments or supplements to the Prospectus.

Neither the Securities and Exchange Commission nor any state securities commission or other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus supplement or the Prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus supplement is June 29, 2026.

 


 

 

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): June 29, 2026

Evommune, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

001-42938

85-0742575

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

1891 Page Mill Road

Palo Alto, CA

94304

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (925) 247-4487

N/A

(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, $0.0001 par value per share

EVMN

The New York Stock Exchange

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 7.01 Regulation FD Disclosure.

On June 29, 2026, Evommune, Inc. (the “Company”) issued a press release titled "Evommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Chronic Spontaneous Urticaria". A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 7.01, including Exhibits 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On June 29, 2026, the Company issued a press release announcing top-line results from its randomized, double-blind, placebo controlled, dose-ranging Phase 2b trial evaluating the efficacy and safety of oral MRGPRX2 antagonist, EVO756, in adults with moderate-to-severe chronic spontaneous urticaria (“CSU”).

The Phase 2b trial enrolled 160 moderate-to-severe antihistamine-refractory CSU patients in the United States, Europe, Canada and Japan. Participants received one of three active dose regimens or placebo. The study did not meet the primary endpoint of mean change in a patient's Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose.

Based on the results of the Phase 2b trial, the Company plans to cease development of EVO756 for CSU. The Company will continue to evaluate EVO756 in additional indications.

Cautionary Note Regarding 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. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of hereof, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to the Company's continued evaluation of EVO756 in additional indications. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, the factors that are described under the caption “Risk Factors” in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 5, 2026, and its subsequent filings with the SEC. The forward-looking statements herein are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward looking statements, except as required by law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

Description

99.1

 

Press Release, dated June 29, 2026, titled "Evommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Chronic Spontaneous Urticaria"

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


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.

 

Evommune, Inc.

Date: June 29, 2026

By:

/s/ Luis Peña

Luis Peña

President and Chief Executive Officer