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Disc Medicine (IRON) trims workforce 20% after FDA letter, books $2M charge

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

Rhea-AI Filing Summary

Disc Medicine, Inc. is implementing a restructuring plan after receiving a complete response letter from the FDA on February 13, 2026 regarding its New Drug Application for bitopertin for erythropoietic protoporphyria and X-linked protoporphyria. The board approved the plan on February 26, 2026.

The company is reducing its workforce by approximately 20%, mainly in commercial and certain supporting functions, and expects to complete the restructuring in the second quarter of 2026. Disc Medicine expects to incur about $2.0 million of charges, primarily severance costs, recorded mainly in the first quarter of 2026, though actual costs may differ and additional expenses are possible.

Positive

  • None.

Negative

  • Regulatory setback and restructuring: The company received an FDA complete response letter for its bitopertin NDA and is responding with a restructuring that cuts approximately 20% of its workforce, signaling pressure on its prior commercialization plans.
  • Restructuring charges and uncertainty: Disc Medicine expects about $2.0 million in primarily severance-related charges, mainly in Q1 2026, and warns that actual and potentially additional costs tied to the restructuring may differ materially from current estimates.

Insights

Disc Medicine is cutting about 20% of staff and booking $2M in restructuring charges after an FDA complete response letter.

The company approved a restructuring plan on February 26, 2026 following an FDA complete response letter on its bitopertin New Drug Application. The plan targets commercial and certain supporting functions, indicating a shift in near-term priorities after this regulatory setback.

The workforce reduction of about 20% and estimated $2.0 million in severance-driven charges, mostly in Q1 2026, represent a focused cost reset. Management expects implementation to finish in Q2 2026, but disclosed that actual and additional costs may differ, adding some execution and financial uncertainty.

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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): February 26, 2026

 

 

DISC MEDICINE, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39438

85-1612845

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

321 Arsenal Street

Suite 101

 

Watertown, Massachusetts

 

02472

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 617 674-9274

 

 

(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 $0.0001 per share

 

IRON

 

The Nasdaq Global 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 2.05 Costs Associated with Exit or Disposal Activities.

On February 26, 2026, the board of directors of Disc Medicine, Inc. (the “Company”) approved, and management began implementing, a restructuring plan (the “Restructuring Plan”) to better align the Company’s workforce with its near-term strategic priorities following the receipt of a complete response letter from the U.S. Food and Drug Administration (“FDA”) on February 13, 2026 with respect to the Company’s New Drug Application for bitopertin for the treatment of erythropoietic protoporphyria and X-linked protoporphyria. Under the Restructuring Plan, the Company is reducing its workforce by approximately 20%. This reduction in staff primarily reflects focused workforce reductions among the Company’s commercial functions and certain supporting functions. The Company expects to complete the implementation of the Restructuring Plan in the second quarter of 2026.

 

The Company expects that it will incur aggregate charges of approximately $2.0 million in connection with the Restructuring Plan, consisting primarily of severance costs, which will be recorded primarily in the first quarter of 2026. The costs that the Company expects to incur in connection with the Restructuring Plan are subject to a number of assumptions, and actual results may differ materially. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the Restructuring Plan.


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.

 

 

 

DISC MEDICINE, INC.

 

 

 

 

Date:

February 27, 2026

By:

/s/ John Quisel, J.D., Ph.D.

 

 

 

Name: John Quisel, J.D., Ph.D.
Title: Chief Executive Officer

 


FAQ

What restructuring did Disc Medicine (IRON) announce in this 8-K?

Disc Medicine approved a restructuring plan on February 26, 2026. It aims to better align its workforce with near-term strategic priorities after an FDA complete response letter related to bitopertin, and focuses reductions on commercial and certain supporting functions.

How many employees will Disc Medicine (IRON) cut under its restructuring plan?

Disc Medicine plans to reduce its workforce by approximately 20%. The reductions primarily affect the company’s commercial operations and certain supporting functions, reflecting a shift in near-term priorities following the FDA complete response letter for its bitopertin New Drug Application.

What restructuring costs does Disc Medicine (IRON) expect to incur?

The company expects aggregate charges of about $2.0 million in connection with the restructuring. These charges will consist primarily of severance costs and are expected to be recorded mainly in the first quarter of 2026, though actual amounts may differ materially.

When will Disc Medicine (IRON) complete its restructuring plan?

Disc Medicine expects to complete implementation of the restructuring plan in the second quarter of 2026. Management has already begun executing the plan after board approval, though the company notes that timing-linked costs and outcomes may vary from current assumptions.

Why is Disc Medicine (IRON) restructuring after the FDA complete response letter?

The restructuring follows an FDA complete response letter dated February 13, 2026, regarding bitopertin’s New Drug Application. Disc Medicine is realigning its workforce, particularly commercial and support roles, to match near-term strategic priorities in light of this regulatory development.

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Disc Medicine Inc

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