IRON receives FDA priority voucher for bitopertin in EPP

Rhea-AI Filing Summary

Disc Medicine (IRON) reported receiving a Commissioner’s National Priority Voucher (CNPV) from the U.S. FDA for bitopertin in erythropoietic protoporphyria (EPP), including X‑linked protoporphyria. The company previously submitted a New Drug Application in September 2025 for patients aged 12 and older under the FDA’s accelerated approval pathway.

The CNPV program, announced in June 2025, is intended to speed development and review of drugs tied to U.S. national health priorities. A CNPV provides benefits such as enhanced communications and rolling review, with the opportunity to reduce application review times to one to two months. This update highlights a potential pathway for a shortened FDA review of bitopertin after the NDA submission.

Insights

Regulatory affairs analyst

FDA CNPV could compress bitopertin's review to 1–2 months.

Disc Medicine received an FDA Commissioner’s National Priority Voucher for bitopertin in EPP. The company filed an NDA in September 2025 under the accelerated approval pathway. The CNPV program, announced in June 2025, targets drugs aligned with national health priorities.

The voucher entitles the sponsor to enhanced communications and rolling review with the opportunity to shorten review timelines to one to two months. This pertains to the FDA review process; it is not a marketing approval.

Future outcomes depend on FDA evaluation of efficacy and safety within the abbreviated window. Subsequent public disclosures may specify scheduling details for the bitopertin review.

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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): October 16, 2025

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 8.01 Other Events.

On October 16, 2025, Disc Medicine, Inc. (the "Company") announced that it received a Commissioner’s National Priority Voucher ("CNPV") from the U.S. Food and Drug Administration ("FDA") for bitopertin in erythropoietic protoporphyria ("EPP"), including X-linked protoporphyria. As previously announced, the Company submitted a New Drug Application to the FDA for bitopertin for patients aged 12 years and older with EPP following the FDA’s accelerated approval pathway in September 2025.

The CNPV program, announced in June 2025, is designed to accelerate the development and review of certain drugs aligned with US national health priorities by offering the opportunity to reduce drug application review times to one to two months. Additionally, companies selected for the program will be issued a voucher entitling them to benefits including enhanced communications and rolling review to allow for shortened review time.

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:	October 17, 2025	By:	/s/ John Quisel, J.D., Ph.D.
			John Quisel, J.D., Ph.D. Chief Executive Officer

FAQ

What did Disc Medicine (IRON) announce?

The company received an FDA Commissioner’s National Priority Voucher for bitopertin in EPP, including X‑linked protoporphyria.

What is the status of bitopertin’s NDA for EPP?

Disc Medicine submitted a New Drug Application in September 2025 under the FDA’s accelerated approval pathway.

What does the FDA CNPV provide to IRON?

It offers enhanced communications and rolling review, with the opportunity to reduce application review times to one to two months.

Which patient population is targeted in the NDA?

Patients aged 12 years and older with erythropoietic protoporphyria, including X‑linked protoporphyria.

When was the CNPV program announced by the FDA?

The program was announced in June 2025 to support drugs aligned with national health priorities.