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Evommune (NYSE: EVMN) begins Phase 2b EVO756 trial in migraine prevention

(Moderate)
(Neutral)
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8-K

Rhea-AI Filing Summary

Evommune, Inc. reports that the first patient has been dosed in a global Phase 2b clinical trial of its oral MRGPRX2 antagonist EVO756 for prophylactic treatment of migraine. The study targets adults with refractory migraine experiencing at least six migraine days per month.

The randomized, double-blind, placebo-controlled, dose-ranging trial will enroll approximately 330 patients across two active doses and placebo for 12 weeks of daily treatment, exploring doses up to 100 mg. The primary endpoint is change in monthly migraine days, with top-line data expected in 2027.

Positive

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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.
Phase 2b trial enrollment Approximately 330 patients Adults with refractory migraine experiencing ≥6 migraine days per month
Treatment duration 12 weeks Randomized, double-blind, placebo-controlled dose-ranging study of EVO756
Maximum daily dose 100 mg Trial exploring daily doses of EVO756 up to 100 mg
Top-line data timing 2027 Company expects top-line data from the Phase 2b migraine trial in 2027
U.S. migraine prevalence More than 40 million people Estimated to affect more than 40 million people in the United States
Global migraine prevalence More than 10 percent of the global population Migraine estimated to affect more than 10 percent of the global population
Eligible for preventive therapy (U.S.) More than 10 million Americans Americans estimated to be eligible for preventive migraine therapy
Added benefit of current preventives over placebo Approximately two days per month Current preventive treatments improve migraine days by about two days more than placebo
MRGPRX2 medical
"potent, highly selective oral small molecule antagonist of MRGPRX2, EVO756"
mrgprx2 is a specific protein on the surface of certain immune cells (mast cells) that acts like a doorbell: when triggered by some drugs or chemicals it can cause those cells to release histamine and other mediators, producing sudden allergic-type reactions. Investors should care because activity at this receptor can explain unexpected drug side effects, affect clinical trial results, regulatory safety reviews, labeling, and commercial viability of therapies, much like a hidden flaw that can derail a product launch.
monthly migraine days (MMD) medical
"The primary endpoint is the mean change from baseline in monthly migraine days (MMD)"
double-blind, placebo-controlled medical
"global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating EVO756"
A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.
prophylactic treatment medical
"EVO756 for the prophylactic treatment of migraine"
CGRP inhibitors medical
"including those who have not responded adequately to CGRP inhibitors"

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FAQ

What did Evommune (EVMN) announce regarding its EVO756 migraine program?

Evommune announced that the first patient was dosed in a global Phase 2b trial of EVO756, an oral MRGPRX2 antagonist being evaluated for prophylactic treatment of migraine in adults with refractory disease and frequent monthly migraine days.

How is Evommune (EVMN)'s Phase 2b trial of EVO756 for migraine designed?

The EVO756 Phase 2b migraine study is a global, randomized, double-blind, placebo-controlled, dose-ranging trial enrolling about 330 adults with refractory migraine for 12 weeks of daily treatment, testing two active dose arms and placebo at doses up to 100 mg.

What are the primary and key secondary endpoints in Evommune (EVMN)'s EVO756 migraine trial?

The primary endpoint is mean change from baseline in monthly migraine days (MMD). Key secondary endpoints include ≥50% and ≥75% MMD responders, changes in monthly headache days, and monthly acute migraine medication use, plus exploratory biomarker and quality-of-life measures.

When does Evommune (EVMN) expect top-line data from the EVO756 Phase 2b migraine trial?

Evommune expects top-line data in 2027 from the Phase 2b trial of EVO756 in migraine prophylaxis, following 12 weeks of treatment in approximately 330 adults with refractory migraine and frequent monthly migraine days.

What unmet migraine treatment need is Evommune (EVMN) targeting with EVO756?

Evommune highlights that more than 10 million Americans are eligible for preventive therapy, yet current options improve migraine days by only about two days over placebo and have high discontinuation rates, supporting the need for differentiated oral preventive approaches like EVO756.

What is EVO756 in Evommune (EVMN)'s pipeline and how does it work?

EVO756 is described as a first-in-class, potent and highly selective oral small molecule antagonist of MRGPRX2, a receptor on mast cells and peripheral sensory neurons, designed to inhibit key neuropeptides implicated in migraine and other chronic inflammatory diseases.
0002044725false00020447252026-07-312026-07-31

 

 

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): July 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 July 30, 2026, Evommune, Inc. (the “Company”) issued a press release titled "Evommune Initiates Phase 2b Clinical Trial of MRGPRX2 Inhibitor EVO756 in Migraine Prophylaxis". 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 Exhibit 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 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

Description

99.1

 

Press Release, dated July 30, 2026, titled "Evommune Initiates Phase 2b Clinical Trial of MRGPRX2 Inhibitor EVO756 in Migraine Prophylaxis"

104

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

 

1


 

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: July 30, 2026

By:

/s/ Luis Peña

Luis Peña

President and Chief Executive Officer

 

2


img108483603_0.jpg

 

Evommune Initiates Phase 2b Clinical Trial of MRGPRX2 Inhibitor EVO756 in Migraine Prophylaxis

‑ MRGPRX2 receptor expressed in human trigeminal neurons and meningeal mast cells, the two key disease-relevant tissues in migraine biology

‑ EVO756 designed to inhibit three key neuropeptides (PACAP, VIP, Substance P) that trigger migraine signal through MRGPRX2

‑ Top-line data expected in 2027

Palo Alto, Calif., and New York, July 30, 2026 – Evommune, Inc. (NYSE: EVMN) (the “Company” or “Evommune”), a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases, today announced the first patient was dosed in its Phase 2b clinical trial evaluating a potent, highly selective oral small molecule antagonist of MRGPRX2, EVO756, for the prophylactic treatment of migraine.

 

"Initiating this migraine trial is an exciting milestone for Evommune and for patients who remain inadequately served by current preventive therapies," said Luis Peña, President and Chief Executive Officer of Evommune. "While the preventive migraine market has seen progress, innovation has largely been limited to a single target and a meaningful proportion of patients continue to experience inadequate relief. A substantial opportunity remains for a front-line oral therapy with a differentiated mechanism. EVO756's dual-action biology, targeting both human trigeminal neurons and meningeal mast cells, combined with its multi-neuropeptide coverage and mechanistic breadth could translate across a wide range of migraine patients, including those who have not responded adequately to CGRP inhibitors. We look forward to reporting top-line data from this trial in 2027."

 

The Phase 2b trial is a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating EVO756 in adults with refractory migraine experiencing ≥6 migraine days per month. Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment. The trial is exploring daily doses of up to 100 mg.

 

Migraine is one of the most disabling neurologic conditions worldwide, yet there remains a significant unmet need for new targeted migraine-specific therapies and for oral options. As a neurologist and headache medicine specialist, the goal of care is to offer patients a more fulfilling, migraine-free life. My hope is to get there with new compelling targets like MRGPRX2, and I look forward to seeing the data generated for EVO756,” said Stewart Tepper, M.D., a clinical trial investigator and Vice President of the New England Institute for Neurology and Headache.

 


 

The primary endpoint of the Phase 2b trial is the mean change from baseline in monthly migraine days (MMD). Key secondary endpoints include the proportion of patients achieving ≥50% and ≥75% reductions in MMD, change from baseline in monthly headache days, and monthly acute migraine medication use. Exploratory endpoints include patient subtyping, changes in migraine-related biomarkers, and changes in migraine-specific quality of life measures.

 

About Migraine

Migraine is a neurological disorder, estimated to affect more than 40 million people in the United States and more than 10 percent of the global population. Beyond headache days, migraine is a leading cause of disability worldwide, and a growing body of evidence shows that the burden between attacks, not just the attacks themselves, is a primary driver of patients seeking care, with many reporting impaired daily functioning even when they are not experiencing an active migraine. More than 10 million Americans are eligible for preventive therapy, yet current treatments are limited to only improving migraine days per month by approximately two days more than placebo, and nearly half of patients on these therapies do not achieve a meaningful reduction in migraine frequency. As a result, more than 80 percent of patients discontinue traditional preventive therapies within a year, and about half modify their treatment regimen without consulting a physician, underscoring the substantial unmet need for new, differentiated approaches to migraine prevention. To learn more, review the Evommune-sponsored webinar here.

 

About EVO756

EVO756 is a first-in-class, potent and highly selective oral small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), a receptor predominantly found on mast cells and peripheral sensory neurons. Evommune seeks to produce the first MRGPRX2-targeted oral treatment for chronic inflammatory diseases, including atopic dermatitis (AD) and migraine, as well as other potential indications.

 

About Evommune, Inc.

Evommune, Inc. is a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases. The Company’s mission is to improve patients’ daily lives and prevent the long-term effects of uncontrolled inflammation that are a consequence of the limitations of existing therapies. To achieve this, Evommune is advancing a portfolio of differentiated product candidates that target key drivers of chronic inflammation. For more information, please visit www.evommune.com and follow us on LinkedIn.

 


 

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential therapeutic benefit of EVO756, and the design, objectives, initiation, timing, progress and results of the Phase 2b clinical trial evaluating EVO756 in migraine. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the Company’s limited operating history and historical losses; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; the impacts of macroeconomic conditions, including heightened inflation and uncertain credit and financial markets, on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the Company’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the Company’s ability to obtain, maintain and protect its intellectual property; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K, filed with the SEC on March 5, 2026, and in other filings that the Company makes and will make with the SEC in the future. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

 

Contacts:

Media:

Paul Laland

Paul.Laland@evommune.com

Investors:

Sarah McCabe

investors@evommune.com

 

 


Filing Exhibits & Attachments

2 documents