Brensocatib HS trial misses endpoints as Insmed (INSM) shuts CEDAR program
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Insmed Incorporated reported that its Phase 2b CEDAR trial of brensocatib in moderate to severe hidradenitis suppurativa did not meet its primary or secondary efficacy endpoints, and the company will discontinue development of brensocatib for HS.
The randomized, double-blind, placebo-controlled study enrolled 214 patients across 72 global sites. At Week 16, abscess and inflammatory nodule counts fell 45.5% and 40.3% in the 10 mg and 40 mg brensocatib arms, compared with a 57.1% reduction on placebo, indicating no efficacy advantage. Safety was consistent with prior studies, with similar rates of treatment-emergent adverse events and no new safety signals at either dose.
Positive
- None.
Negative
- Brensocatib failed in HS and the program is being discontinued, as the Phase 2b CEDAR study did not meet primary or secondary efficacy endpoints and placebo outperformed both active-dose arms on lesion reduction.
Insights
Brensocatib failed to outperform placebo in HS, leading Insmed to end this indication despite a clean safety profile.
The CEDAR Phase 2b study tested brensocatib 10 mg and 40 mg once daily versus placebo in 214 adults with moderate to severe hidradenitis suppurativa over 16 weeks. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule count.
At Week 16, reductions in lesion counts were 45.5% and 40.3% for the brensocatib 10 mg and 40 mg arms, compared with 57.1% on placebo, showing no efficacy benefit. On safety, treatment-emergent adverse event rates and serious events were broadly similar across arms, and no new safety signals emerged, even at the highest studied 40 mg dose.
Insmed will discontinue development of brensocatib in HS, removing this disease from the drug’s potential label. Future company disclosures may clarify how resources are reallocated across its remaining pulmonary and inflammatory programs.
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
CEDAR enrollment: 214 patients
Study sites: 72 sites
Treatment duration: 16 weeks
+5 more
8 metrics
CEDAR enrollment
214 patients
Adults with moderate to severe hidradenitis suppurativa in Phase 2b CEDAR study
Study sites
72 sites
Global locations participating in the CEDAR Phase 2b HS trial
Treatment duration
16 weeks
Once-daily brensocatib or placebo in placebo-controlled period
AN reduction brensocatib 10 mg
45.5%
Percent reduction in abscess and inflammatory nodule count at Week 16
AN reduction brensocatib 40 mg
40.3%
Percent reduction in abscess and inflammatory nodule count at Week 16
AN reduction placebo
57.1%
Percent reduction in abscess and inflammatory nodule count at Week 16
Any TEAE brensocatib 10 mg
41 of 74 (55.4%)
Treatment-emergent adverse events during 16-week placebo-controlled period
Any TEAE placebo
32 of 70 (45.7%)
Treatment-emergent adverse events during 16-week placebo-controlled period
Key Terms
topline efficacy and safety results, hidradenitis suppurativa, Phase 2b, randomized, double-blind, placebo-controlled, +2 more
6 terms
topline efficacy and safety results clinical
"issued a press release announcing topline efficacy and safety results from its Phase 2b CEDAR study"
hidradenitis suppurativa medical
"brensocatib in patients with hidradenitis suppurativa ("HS")"
A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.
Phase 2b clinical
"the Phase 2b CEDAR study, which evaluated brensocatib in adult patients"
Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.
randomized, double-blind, placebo-controlled clinical
"The CEDAR study was a randomized, double-blind, placebo-controlled study"
A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.
treatment-emergent adverse event medical
"Treatment-emergent adverse event ("TEAE") percentages during the 16-week placebo-controlled treatment period"
An event is called a treatment-emergent adverse event when a new or worsening unwanted health effect appears after a person starts a drug or medical treatment, typically measured from the first dose onward in clinical studies. Investors watch these events because they can stop or slow product approval, raise development costs, or undermine market confidence—like a widely reported defect in a new gadget that triggers recalls and damages sales.
forward-looking statements regulatory
"This press release contains forward-looking statements that involve substantial risks and uncertainties."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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
(Exact name of registrant as specified in its charter)
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(Address of principal executive offices)
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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):
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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))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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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:
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Brensocatib
10 mg Once Daily
(N=74)
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Brensocatib
40 mg Once Daily
(N=70)
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Placebo
(N=70)
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Any TEAE, n (%)
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41 (55.4)
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30 (42.9)
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32 (45.7)
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Severe TEAE, n (%)
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1 (1.4)
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0
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0
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Serious TEAE, n (%)
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3 (4.1)
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1 (1.4)
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1 (1.4)
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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
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Exhibit
No.
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Description
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99.1
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Press release issued by Insmed Incorporated on April 7, 2026.
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104
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Cover Page Interactive Date File (embedded within the Inline XBRL document).
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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.
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Dated: April 7, 2026
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INSMED INCORPORATED
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By:
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/s/ Michael A. Smith
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Name:
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Michael A. Smith
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Title:
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Chief Legal Officer and Corporate Secretary
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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:
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Brensocatib
10 mg Once Daily
(N=74)
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Brensocatib
40 mg Once Daily
(N=70)
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Placebo
(N=70)
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Any TEAE, n (%)
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41 (55.4)
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30 (42.9)
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32 (45.7)
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Severe TEAE, n (%)
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1 (1.4)
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0
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0
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Serious TEAE, n (%)
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3 (4.1)
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1 (1.4)
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1 (1.4)
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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,
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 (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
FAQ
What did Insmed (INSM) announce about the CEDAR Phase 2b HS study?
Insmed announced that the Phase 2b CEDAR study of brensocatib in adults with moderate to severe hidradenitis suppurativa did not meet its primary or secondary efficacy endpoints. As a result, the company will discontinue development of brensocatib for HS while planning to present the data at a future congress.
How effective was brensocatib versus placebo in Insmed’s HS trial?
At Week 16, brensocatib 10 mg and 40 mg arms showed a 45.5% and 40.3% reduction from baseline in abscess and inflammatory nodule count, respectively. The placebo arm showed a 57.1% reduction, meaning brensocatib did not outperform placebo on the primary efficacy endpoint in hidradenitis suppurativa.
What were the safety results for brensocatib in Insmed’s CEDAR study?
Brensocatib was generally well tolerated, with safety consistent with previous studies and no new safety signals identified, including at the 40 mg dose. Treatment-emergent adverse events occurred in 55.4% of patients on 10 mg, 42.9% on 40 mg, and 45.7% on placebo during the 16-week placebo-controlled period.
How many patients were enrolled in Insmed’s Phase 2b CEDAR HS trial?
The CEDAR study enrolled 214 adult patients with moderate to severe hidradenitis suppurativa across 72 sites globally. Participants were randomized 1:1:1 to receive brensocatib 10 mg, brensocatib 40 mg, or placebo once daily for 16 weeks, followed by continued brensocatib treatment after the initial period.
What decision did Insmed (INSM) make about brensocatib in hidradenitis suppurativa?
Insmed decided to discontinue its development program of brensocatib in hidradenitis suppurativa. This decision follows the Phase 2b CEDAR trial’s failure to meet primary and secondary efficacy endpoints, despite a safety profile that remained consistent with prior brensocatib studies and showed no new safety concerns.
What type of clinical trial design was used in Insmed’s CEDAR study?
The CEDAR study used a randomized, double-blind, placebo-controlled Phase 2b design. Adult patients with moderate to severe hidradenitis suppurativa received brensocatib 10 mg, brensocatib 40 mg, or placebo once daily for 16 weeks, with the primary endpoint focused on percent change in abscess and inflammatory nodule counts.