Form 8-K

8-K — Edgewise Therapeutics, Inc.

Accession: 0001104659-26-082902

Filed: 2026-07-13

Period: 2026-07-10

CIK: 0001710072

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Completion of Acquisition or Disposition of Assets

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2620181d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2620181d1_ex99-1.htm)

GRAPHIC (tm2620181d1_ex99-1img001.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm2620181d1_8k.htm · Sequence: 1

false

0001710072

2026-07-10

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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 10, 2026

Edgewise Therapeutics, Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-40236

82-1725586

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS

Employer

Identification No.)

1715

38th St.

Boulder,

CO 80301

(Address of principal executive offices) (Zip Code)

(720)

262-7002

(Registrant’s telephone number, including

area code)

Not Applicable

(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 (see General Instruction A.2.

below):

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

EWTX

The

Nasdaq Global Select 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 2.01 Completion of Acquisition or Disposition of Assets

On July 10, 2026, Edgewise

Therapeutics, Inc. (the “Company”) completed the previously announced acquisition of the Company’s sevasemten compound

and certain other related assets collectively constituting the Company’s muscular dystrophy program (the “Program”)

by Servier Pharmaceuticals LLC and Les Laboratoires Servier (together, the “Buyers”, and such transaction, the “Transaction”),

pursuant to the terms and conditions of the previously announced Asset Purchase Agreement by and among the Company and the Buyers. The

Buyers acquired the Program for $1.55 billion in upfront cash consideration and up to $1.1 billion in additional milestone payments, for

aggregate potential consideration of up to $2.65 billion. The Transaction was completed on the terms described in the Company’s

Current Report on Form 8-K filed on June 1, 2026.

Item 7.01 Regulation FD Disclosure.

On July 13, 2026,

the Company issued a press release announcing the completion of the Transaction. A copy of the press release is attached as Exhibit 99.1

to this Current Report on Form 8-K and incorporated by reference herein.

The information set

forth 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 (the “Exchange Act”), or incorporated by reference in any filing under the Securities

Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(b) Pro forma financial information.

The Company intends to file the pro forma financial information required

by Item 9.01(b) of Form 8-K under cover of a Form 8-K/A no later than four business days after the completion of the Transaction.

(d) Exhibits:

Exhibit No.

Description

99.1

Press Release, dated July 13, 2026

104

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

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.

EDGEWISE THERAPEUTICS,

INC.

By:

/s/

Michael Nofi

Michael

Nofi

Chief

Financial Officer

Date: July 13, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2620181d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

NEWS RELEASE

Edgewise Therapeutics Completes Sale of Sevasemten

for Up to $2.65 Billion, Strengthening Balance Sheet and Centering Company Focus on Cardiovascular Pipeline

— Edgewise receives $1.55 billion in upfront

cash and is eligible to receive up to $1.1 billion in regulatory and commercial milestones —

— Transaction creates strategically focused cardiovascular company —

— Upfront proceeds expected to fully fund EDG-7500 development through potential approval —

Boulder, Colo., (July 13, 2026) — Edgewise Therapeutics,

Inc. (Nasdaq: EWTX), a leading clinical-stage biopharmaceutical company focused on cardiovascular diseases, today announced the successful

completion of its previously announced definitive agreement under which Servier, an independent international pharmaceutical group governed

by a foundation, acquired sevasemten and Edgewise’s muscular dystrophy business for $1.55 billion in upfront cash consideration

and up to $1.1 billion in additional milestone payments, for aggregate potential consideration of up to $2.65 billion. The transaction

meaningfully strengthens Edgewise’s balance sheet, providing enhanced financial flexibility and sharpening the Company’s strategic

focus to accelerate and unlock the full potential of its cardiovascular pipeline. This transaction marks Edgewise’s transition to

a cardiovascular-focused company, with a pipeline comprising EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003

for an undisclosed target.

Under the terms of the agreement, Servier acquired all rights to sevasemten,

including related intellectual property, know-how, key agreements, regulatory filings, and clinical data required to operate the muscular

dystrophy business. The core Edgewise employee group primarily supporting the muscular dystrophy business received offers to transition

to Servier to ensure continuity of development and future commercial execution. The transaction reflects Edgewise's strategic focus on

advancing its cardiovascular portfolio, while positioning sevasemten with Servier, which brings the global development, regulatory, and

commercial capabilities required to fully realize sevasemten's potential for patients.

“Completing this transaction with Servier marks an important

milestone for Edgewise and for the sevasemten program,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise

Therapeutics. “I want to thank the many colleagues whose dedication and expertise have advanced sevasemten to this point; this progress

would not have been possible without their contributions. We’re confident Servier’s global scale, deep expertise in rare diseases,

and commitment to patients will help fully realize sevasemten’s potential for individuals living with Becker and Duchenne muscular

dystrophy. This transaction also strengthens our balance sheet and provides the financial flexibility to advance EDG-7500 and EDG-15400

through key value-inflection points.”

“Edgewise

is a pioneer in muscle disease biology with a proven track record of discovering and developing precision therapies for patients with

serious neuromuscular conditions,” said Olivier Laureau, President of Servier. “With the successful closing of this acquisition,

we are pleased to welcome a highly experienced team and a strong ambition in Becker and Duchenne muscular dystrophy to Servier. This is

a strategic milestone in achieving Servier 2030 to become a

new player in rare neurology and to serve patients living with devastating rare diseases.”

Advancing the Cardiovascular Pipeline

Separately, based on recent positive 12-week data from Part D of the

CIRRUS-HCM Phase 2 trial of EDG-7500, which included safety, echocardiographic, biomarker, and patient-reported outcome assessments across

both oHCM and nHCM, the Company is expecting to initiate a Phase 3 trial in the fourth quarter of 2026. In parallel, Edgewise remains

on track to initiate a Phase 2 trial of EDG-15400 in heart failure with preserved ejection fraction (HFpEF), further advancing the Company’s

cardiovascular pipeline. Additionally, the Company believes the upfront proceeds from this transaction, combined with its existing cash

position, will fully fund EDG-7500 development through potential approval and provide the financial strength to further build and expand

its cardiovascular pipeline.

Advisors

Centerview Partners LLC acted as exclusive financial advisor to Edgewise,

with Wilson Sonsini Goodrich & Rosati serving as legal counsel.

About Sevasemten

Sevasemten presents a novel mechanism of action designed to selectively

limit the exaggerated muscle damage caused by the absence or loss of functional dystrophin. Sevasemten is being studied in late-stage

clinical trials in Becker and Duchenne muscular dystrophy. If approved, sevasemten would be the first therapy indicated for Becker muscular

dystrophy, a rare, genetic, X-linked neuromuscular disorder that predominantly affects males and for which approximately 12,000 individuals

are affected in the U.S., EU-5, and Japan.

Sevasemten has demonstrated sustained disease stabilization in clinical

studies spanning more than three years of treatment. In the MESA open-label extension study, participants maintained stable North Star

Ambulatory Assessment (NSAA) scores in marked contrast to the functional decline expected from Becker natural history data. Sevasemten

has maintained a favorable safety and tolerability profile, with no discontinuations or dose reductions due to adverse events.

Sevasemten has achieved notable regulatory milestones by securing FDA

Orphan Drug Designation for the treatment of Becker and Duchenne, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne,

and Fast Track designations for the treatment of Becker and Duchenne. Further, sevasemten secured EMA Orphan Drug Designations for the

treatment of Becker and Duchenne.

The GRAND CANYON pivotal cohort in Becker is fully enrolled with 175

participants and powered at greater than 98% to deliver a statistically significant difference versus placebo, with top-line data expected

in the fourth quarter of 2026.

About Edgewise Therapeutics

Edgewise Therapeutics is a leading biopharmaceutical company focused

on novel, muscle-targeted therapeutics. Leveraging its expertise in muscle biology and small molecule drug development, Edgewise is advancing

a cardiovascular pipeline targeting significant unmet needs, including hypertrophic cardiomyopathy, heart failure and other serious cardiovascular

and cardiometabolic conditions. To learn more, go to edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements as that term

is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this

press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other

things, statements regarding the sale of sevasemten and Edgewise's muscular dystrophy business to Servier (Transaction), including potential

payments which may become owing to Edgewise; the impact and effects of the Transaction on Edgewise’s business and financial position;

Edgewise’s cash runway and use of proceeds from the Transaction; the potential of, and expectations regarding sevasemten and Edgewise's

product candidates and programs, including EDG-7500, EDG-15400 and EDG-003; statements regarding Edgewise's expectations relating to its

clinical trials, including the timing of top-line data for the GRAND CANYON pivotal cohort in Becker; the timing of initiation of a Phase

3 trial of EDG-7500 and a Phase 2 trial of EDG-15400 in HFpEF; statements regarding Edgewise's ability to advance its pipeline; and statements

by Edgewise's President and Chief Executive Officer and Servier’s President. Words such as "believes," "anticipates,"

"plans," "expects," "intends," "will," "goal," “targets,” "potential"

and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are

based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual

results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including

but not limited to: risks related to milestones related to the Transaction not being met; risks associated with Edgewise's limited operating

history, its product candidates being early in development and not having products approved for commercial sale; risks associated with

Edgewise not having generated any revenue to date; Edgewise's ability to achieve objectives relating to the discovery, development and

commercialization of its product candidates, if approved; Edgewise's substantial dependence on the success of EDG-7500 and EDG-15400;

Edgewise's ability to develop and commercialize EDG-7500 and EDG-15400 and to discover, develop and commercialize other product candidates

in its cardiovascular programs, including EDG-003; risks related to Edgewise's clinical trials of its product candidates not demonstrating

safety and efficacy; risks related to Edgewise's product candidates causing serious adverse events, toxicities or other undesirable side

effects; the outcome of preclinical testing and early clinical trials not being predictive of the success of later clinical trials and

the risks related to the results of Edgewise's clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties

in the enrollment and/or maintenance of patients in clinical trials; Edgewise's need for additional capital to finance its operations;

risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim,

topline and preliminary data from Edgewise's clinical trials changing as more patient data becomes available; risks related to failure

to develop a proprietary drug discovery platform; risks related to exposure to additional risk if Edgewise develops programs in connection

with other therapies; risks related to production of drugs by Edgewise's third-party manufacturers; risks related to changes in methods

of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks related to the patient

population for its product candidates having a small patient population; risks related to the regulatory approval processes of domestic

and foreign authorities being lengthy, time consuming and inherently unpredictable; risks relating to disruptions at the FDA, the SEC

and other government agencies; risks relating to Edgewise's ability to attract and retain highly skilled executive officers and employees;

Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; Edgewise's reliance on third parties;

risks related to future acquisitions or strategic partnerships; risks related to general economic and market conditions; and other risks.

Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that

Edgewise files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements are made as

of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons

why actual results could differ from those projected in the forward-looking statements, except as required by law.

Contacts

Investors:

Behrad Derakhshan, Ph.D., Chief Operating Officer

ir@edgewisetx.com

Media:

Maureen Franco, VP Corporate Communications

media@edgewisetx.com

GRAPHIC

Filename: tm2620181d1_ex99-1img001.jpg · Sequence: 6

Binary file (4102 bytes)

Download tm2620181d1_ex99-1img001.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.1

Cover

Jul. 10, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Jul. 10, 2026

Entity File Number

001-40236

Entity Registrant Name

Edgewise Therapeutics, Inc.

Entity Central Index Key

0001710072

Entity Tax Identification Number

82-1725586

Entity Incorporation, State or Country Code

Entity Address, Address Line One

1715

38th St.

Entity Address, City or Town

Boulder

Entity Address, State or Province

Entity Address, Postal Zip Code

80301

City Area Code

720

Local Phone Number

262-7002

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common

Stock, $0.0001 par value per share

Trading Symbol

EWTX

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration