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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 19, 2026

Disc Medicine, Inc.

(Exact name of Registrant as Specified in Its Charter)

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Delaware		001-39438		85-1612845
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

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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

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 (see General Instruction A.2. below):

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☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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☐	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:

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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. ☐

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Item 7.01

Regulation FD Disclosure.

On October 19, 2026, Disc Medicine, Inc. (the “Company”) issued a press release titled “Disc Medicine Announces Success on All Primary and Secondary Endpoints in the Pivotal Phase 3 APOLLO Trial of Bitopertin in Adults and Adolescents with Erythropoietic Protoporphyria (EPP).” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 (the “Securities Act”) or the Exchange Act, except as expressly provided by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

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Item 8.01

Other Events.

Webcast Presentation

2026年10月19日，该公司将举办网络直播，讨论在红细胞生成性原卟啉症（“EPP”）中bitopertin的APOLLO III期试验的初步结果。网络直播的演示文稿作为本Form 8-K当前报告的附件99.2提交，并通过引用并入本文。该演示文稿还将出现在该公司网站的投资者关系部分，网址为https://ir.discmedicine.com。该公司网站上的信息并未通过引用并入本Form 8-K当前报告，因此您不应将该公司网站上的任何信息，或从该公司网站可以访问的信息视为本Form 8-K当前报告的一部分。

Bitopertin：III期APOLLO初步数据结果

2026年10月19日，该公司宣布在EPP中bitopertin的APOLLO III期试验取得积极的初步结果，包括X-连锁原卟啉症（“XLP”）。该试验达到了所有主要和次要终点。

APOLLO是一项随机、双盲的关键III期试验，评估bitopertin与安慰剂在12岁及以上患有EPP或XLP的成人和青少年中的安全性和有效性。该试验在美国、加拿大、欧洲和澳大利亚招募了183名患者，根据基线光照耐受性和地理区域进行分层，并以1:1的比例随机分配接受每日一次60毫克口服bitopertin或安慰剂，持续6个月。

初步结果摘要：

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•

与安慰剂相比，bitopertin在两个主要联合终点上均达到统计学显著性：

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•

从基线开始的全血无金属原卟啉IX（“PPIX”）减少量（-41.4% vs. 安慰剂，p<0.0001）

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•

第6个月期间无疼痛的平均每月总光照时间增加量（+12.2小时 vs. 安慰剂，p=0.0010）

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•

与安慰剂相比，bitopertin在所有次要终点上均达到统计学显著性，包括：

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在6个月治疗期间光毒性反应发生率的降低（p<0.0001）

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•

在6个月治疗期间无疼痛的累计总光照时间增加（p<0.0001）

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•

在治疗期间从基线开始的平均每日日光暴露时间到前驱症状的变化（p=0.0077，仅限成人）

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•

与安慰剂相比，bitopertin显示出额外的生活质量改善，包括改善的患者整体变化印象（“PGIC”）评分（p<0.0001）和患者整体严重程度印象（“PGIS”）评分（p<0.0001）

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•

bitopertin总体耐受性良好。与之前的研究一致，bitopertin组中最常报告的治疗出现的不良事件（“TEAE”）是头晕（50%），且为轻度或中度，通常为暂时性的。没有出现3级以上的TEAE。

APOLLO临床试验为支持bitopertin在EPP中的潜力提供了大量临床数据。基于这些结果，该公司计划在2026年底向美国食品药品监督管理局（“FDA”）重新提交新药申请（“NDA”），预计FDA将在2027年年中做出决定。

本表格8-K文件包含根据《证券法》第27A条和《交易法》第21E条定义的前瞻性声明。关于公司期望、信念、计划、目标、假设或未来事件或业绩的任何陈述都不是历史事实，可能是前瞻性声明。这些声明通常但不总是通过使用诸如“可能”、“将”、“可以”、“应该”、“预期”、“打算”、“计划”、“预期”、“相信”、“估计”、“预测”、“项目”、“寻求”、“努力”、“潜力”、“继续”以及类似表达，或这些术语的否定形式，或类似表达来作出的。这些前瞻性声明包括关于公司对bitopertin下一阶段开发计划的期望、与监管机构就bitopertin的预期互动，包括NDA重新提交和FDA决定的时间；以及如果获得批准，bitopertin作为EPP治疗的潜在治疗益处。因此，这些声明涉及估计、假设、风险和不确定性，可能导致实际结果与这些声明中表达的结果有重大差异，包括与公司资本充足性以支持其未来运营以及其成功启动和完成临床试验的能力相关的不确定性；公司的性质、策略和重点；预测公司产品候选人的开发时间和成本的困难；公司研究、开发和商业化其当前和未来产品候选人的计划；公司计划的非临床研究和临床试验的启动时间；公司临床试验数据的可用时间；公司识别具有显著商业潜力的额外产品候选人的能力以及在血液疾病领域扩展其产品管线的能力；公司非临床研究和临床试验的时间和预期结果，以及公司非临床研究和临床试验的结果可能无法预测未来研究或临床试验的未来结果，可能无法支持进一步开发和市场批准的风险；以及FDA和其他监管机构做出决策的内容和时间。公司的前瞻性声明还涉及一些假设，如果这些假设被证明是错误的，将导致其结果与这些前瞻性声明所表达或暗示的结果有重大差异。公司业务的其他风险在公司2026年6月30日止季度的季度报告表格10-Q以及公司不时向证券交易委员会提交的其他文件中有更详细的描述。公司没有义务，且明确否认任何此类义务，更新或更改其前瞻性声明，无论是否由于新信息、未来事件或其他原因。

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项目9.01。

附录。

（d）附录

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附录编号		描述
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99.1		Disc Medicine, Inc.于2026年10月19日发布的新闻稿，随附提供。
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99.2		Disc Medicine, Inc.投资者介绍资料，随附提供。
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104		封面页面交互式数据文件（嵌入在内联XBRL文档中）

签名

根据1934年《证券交易法》的要求，注册人已 duly 促使本报告由此处 duly 授权的人员代表其签署。

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\n		\n		DISC 药物公司，股份有限公司
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日期：2026年10 月19日		\n		由：		/s/ John Quisel
\n		\n		姓名：		John Quisel，J.D., Ph.D.
\n		\n		职位：		首席执行官

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