Keros Therapeutics (KROS) wins FDA Orphan Drug status for KER-065 in DMD

Rhea-AI Filing Summary

Keros Therapeutics reported that the U.S. Food and Drug Administration granted Orphan Drug designation to its investigational therapy KER-065 for treating Duchenne muscular dystrophy. This special status is reserved for drugs targeting rare, serious conditions and can provide regulatory and economic incentives to support development. The company disclosed this update through a press release, which is attached as an exhibit and incorporated by reference.

Insights

Biotech regulatory and pipeline analyst

FDA Orphan Drug designation strengthens Keros’s KER-065 program in Duchenne muscular dystrophy.

The disclosure centers on the U.S. FDA granting Orphan Drug designation for KER-065 in Duchenne muscular dystrophy. Orphan status typically reflects an unmet medical need in a rare disease and can offer benefits such as fee reductions, development incentives, and potential marketing exclusivity upon approval, making a program more attractive to advance.

For Keros, this designation supports the strategic value of its muscular dystrophy effort, even though no efficacy, safety, or timing details are provided here. The actual impact will depend on KER-065’s subsequent clinical performance and future regulatory milestones described in later updates.

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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): August 20, 2025

Keros Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-39264

81-1173868

(state or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

1050 Waltham Street, Suite 302 Lexington, Massachusetts

02421

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 314-6297

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:

☐ 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

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

KROS

The Nasdaq Stock Market LLC

Preferred Share Purchase Rights

N/A

The Nasdaq Stock Market LLC

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 8.01     Other Events.

On August 20, 2025, Keros Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration granted Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and, other than the quotes contained therein, is incorporated herein by reference.

Item 9.01     Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.						Description
99.1						Press Release dated August 20, 2025.
104						Cover Page Interactive Data File (the cover page XBRL tags are 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.

KEROS THERAPEUTICS, INC.
By:						/s/ Jasbir Seehra
						Jasbir Seehra, Ph.D. Chief Executive Officer

Dated: August 20, 2025

FAQ

What did Keros Therapeutics (KROS) announce in this Form 8-K?

Keros Therapeutics reported that the U.S. FDA granted Orphan Drug designation to its investigational therapy KER-065 for the treatment of Duchenne muscular dystrophy.

Which Keros Therapeutics drug received FDA Orphan Drug designation?

The investigational therapy KER-065 received Orphan Drug designation from the U.S. FDA for treating Duchenne muscular dystrophy.

What disease area is KER-065 targeting for Keros Therapeutics (KROS)?

KER-065 is being developed for the treatment of Duchenne muscular dystrophy, a serious neuromuscular disease, and has received FDA Orphan Drug designation for this use.

How did Keros Therapeutics disclose the Orphan Drug designation for KER-065?

Keros disclosed the Orphan Drug designation for KER-065 in a Form 8-K and attached a press release dated August 20, 2025 as Exhibit 99.1.

Where can investors find more details on Keros Therapeutics’ Orphan Drug news?

Additional details are provided in the press release dated August 20, 2025, which is attached to the Form 8-K as Exhibit 99.1 and incorporated by reference.