Form 8-K

8-K — INSMED Inc

Accession: 0001140361-26-013659

Filed: 2026-04-07

Period: 2026-04-07

CIK: 0001104506

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ef20070042_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20070042_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20070042_8k.htm · Sequence: 1

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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): April 7, 2026

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

Virginia

000-30739

54-1972729

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

700 US Highway 202/206

Bridgewater, New Jersey

08807

(Zip Code)

(Address of principal executive offices)

Registrant’s telephone number, including area code: (908) 977-9900

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, par value $0.01 per share

INSM

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 (17 CFR 230.405) or Rule 12b-2 of the

Securities Exchange Act of 1934 (17 CFR 240.12b-2).

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 7.01 — Regulation FD Disclosure.

On April 7, 2026, Insmed Incorporated (the “Company”) issued a press release announcing topline efficacy and safety results from its Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa

(“HS”). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information contained in 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 8.01 — Other Events.

On April 7, 2026, the Company issued a press release announcing topline efficacy and safety results from its Phase 2b CEDAR study of brensocatib in patients with HS. The CEDAR study was a randomized,

double-blind, placebo-controlled study to evaluate the efficacy and safety of brensocatib in adults with moderate to severe HS. The study enrolled 214 patients at 72 sites globally. In the study, participants were randomized 1:1:1 to

receive brensocatib 10 mg, brensocatib 40 mg, or placebo, once daily for 16 weeks. After the first 16 weeks, participants either continued the same randomized dose of brensocatib, or if on placebo, were randomized to receive brensocatib 10 mg or 40

mg. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule (“AN”) count at Week 16.

At Week 16, study participants experienced a 45.5% and 40.3% reduction from baseline in AN count in the brensocatib 10 mg and 40 mg arms, respectively, compared to a

57.1% reduction in the placebo arm. Treatment-emergent adverse event (“TEAE”) percentages during the 16-week placebo-controlled treatment period were:

Brensocatib

10 mg Once Daily

(N=74)

Brensocatib

40 mg Once Daily

(N=70)

Placebo

(N=70)

Any TEAE, n (%)

41 (55.4)

30 (42.9)

32 (45.7)

Severe TEAE, n (%)

1 (1.4)

Serious TEAE, n (%)

3 (4.1)

1 (1.4)

The Company will discontinue its development program of brensocatib in HS and intends to present these data at a future congress.

Forward-Looking Statements

The forward-looking statements in this Current Report on Form 8-K are based upon the Company’s current expectations and beliefs, and involve known and unknown risks,

uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated

or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that topline data from the Company’s clinical trials, including the CEDAR study, that the Company announces or

publishes from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials, including due to the Company’s potential

inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to the Company’s product

candidates; and the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature,

forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's

business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and any subsequent Company filings with the Securities and Exchange Commission (the “SEC”).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date hereof. The Company disclaims any

obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based,

or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

ITEM 9.01 – Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release issued by Insmed Incorporated on April 7, 2026.

104

Cover Page Interactive Date File (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.

Dated: April 7, 2026

INSMED INCORPORATED

By:

/s/ Michael A. Smith

Name:

Michael A. Smith

Title:

Chief Legal Officer and Corporate Secretary

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20070042_ex99-1.htm · Sequence: 2

Exhibit 99.1

Insmed Provides Clinical Update on Phase 2b CEDAR Study

—Study Did Not Meet Primary or Secondary Efficacy Endpoints; Insmed Will Discontinue HS Program—

—Safety Was Consistent with Previous Studies and No New Safety Signals Were Identified for Either Dose of Brensocatib—

BRIDGEWATER, N.J., Apr. 7, 2026 -- Insmed Incorporated (Nasdaq: INSM), a people-first global

biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the Phase 2b CEDAR study, which evaluated brensocatib in adult patients with

moderate to severe hidradenitis suppurativa (HS), did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. Brensocatib was well tolerated,

with no new safety signals identified, including in the 40 mg arm, which is the highest dose Insmed has studied to date. Insmed will discontinue its development program of brensocatib in HS and intends to present these data at a future

congress.

“The CEDAR study was designed as a proof-of-concept study to determine whether brensocatib could provide benefit for patients with HS—a disease where the lack of

established animal models makes clinical development particularly challenging,” said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. “While we are disappointed in the results, we hope that insights gained from this study will contribute

to the broader scientific understanding of HS. We are grateful to the patients and investigators who participated in this study.”

At Week 16, study participants experienced a 45.5% and 40.3% reduction from baseline in total

abscess and inflammatory nodule (AN) count in the brensocatib 10 mg and 40 mg arms, respectively compared to a 57.1% reduction in the placebo arm. Treatment-emergent adverse event (TEAE) percentages during the 16-week placebo-controlled treatment

period were:

Brensocatib

10 mg Once Daily

(N=74)

Brensocatib

40 mg Once Daily

(N=70)

Placebo

(N=70)

Any TEAE, n (%)

41 (55.4)

30 (42.9)

32 (45.7)

Severe TEAE, n (%)

1 (1.4)

Serious TEAE, n (%)

3 (4.1)

1 (1.4)

About the Phase 2b CEDAR Study

CEDAR was a randomized, double-blind, placebo-controlled, Phase 2b study to evaluate the efficacy and safety of brensocatib in adults with moderate to severe hidradenitis

suppurativa. The study enrolled 214 patients at 72 sites globally. In the study, participants were randomized 1:1:1 to receive brensocatib 10 mg, brensocatib 40 mg, or placebo, once daily for 16 weeks. After the first 16 weeks, participants either

continued the same randomized dose of brensocatib, or if on placebo, were randomized to receive brensocatib 10 mg or 40 mg. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule (AN) count at Week 16.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing

serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most

advanced programs are in pulmonary and inﬂammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene

therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one

of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the

Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates,"

"believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and

other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in

any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that topline data from the Company’s clinical trials, including the CEDAR study, that the Company announces or publishes from

time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials, including due to the Company’s potential inability to enroll or

retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to the Company’s product candidates; and the cost and

potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature,

business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and

any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company

disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements

may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:

Bryan Dunn

Vice President, Investor Relations

(646) 812-4030

investor.relations@insmed.com

Media:

Claire Mulhearn

Vice President, Corporate Communications

(862) 842-6819

media@insmed.com

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