Insmed Provides Clinical Update on Phase 2b CEDAR Study
Rhea-AI Summary
Insmed (Nasdaq: INSM) reported that the Phase 2b CEDAR study of brensocatib in adult hidradenitis suppurativa (HS) did not meet primary or secondary efficacy endpoints for either 10 mg or 40 mg arms. Insmed will discontinue its HS development program.
Safety was consistent with prior studies and no new safety signals were identified, including at 40 mg. At Week 16, AN count reductions were 45.5% (10 mg), 40.3% (40 mg) and 57.1% (placebo). Reported TEAEs: Any TEAE 55.4% (10 mg), 42.9% (40 mg), 45.7% (placebo); severe TEAE 1.4% (10 mg); serious TEAE 4.1% (10 mg), 1.4% (40 mg), 1.4% (placebo).
Positive
- No new safety signals identified up to the 40 mg dose
- Brensocatib was generally well tolerated across both dose arms
- Company plans to present CEDAR data at a future congress
Negative
- Study failed to meet primary and secondary efficacy endpoints
- Insmed will discontinue the brensocatib HS development program
- Placebo reduction in AN count (57.1%) exceeded both active arms
News Market Reaction – INSM
On the day this news was published, INSM declined 1.75%, reflecting a mild negative market reaction. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $601M from the company's valuation, bringing the market cap to $33.72B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
INSM was up 0.85% while key biotech peers were mixed: BNTX +0.52%, ARGX +1.02%, GMAB +1.35%, versus ONC -2.85% and REGN -0.49%. No coordinated sector move is evident.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 23 | Clinical trial results | Positive | +5.9% | Phase 3b ENCORE trial met primary and key culture conversion endpoints. |
| Mar 05 | Equity inducement grants | Neutral | -4.2% | Inducement RSUs and options granted to 85 new employees under plan. |
| Feb 19 | Earnings and guidance | Positive | +6.5% | 2025 revenue of $606.4M and strong 2026 product revenue expectations. |
| Feb 13 | Investor conferences | Neutral | +1.8% | Announcement of management presentations at two March 2026 conferences. |
| Feb 05 | Earnings call scheduling | Neutral | -0.9% | Scheduled date and access details for Q4 and full‑year 2025 call. |
Shares have tended to rise on strong clinical and earnings updates, while neutral corporate news has produced mixed or negative moves.
Over the last few months, Insmed has reported multiple milestones. On Feb 19, 2026 earnings highlighted $606.4M in 2025 revenue and the stock rose 6.54%. A positive Phase 3b ENCORE readout on Mar 23 lifted shares 5.87%. In contrast, neutral items like inducement grants on Mar 5 and conference participation on Feb 13 saw modest declines or small gains. Today’s negative Phase 2b CEDAR outcome contrasts with that generally favorable backdrop of recent clinical and financial progress.
Market Pulse Summary
This announcement details that the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa did not meet primary or secondary efficacy endpoints, and the HS program will be discontinued despite a generally tolerable safety profile. In the context of recent positive trial and earnings updates, this represents a setback for one indication rather than the entire franchise. Investors may watch future clinical readouts and regulatory milestones, as well as performance of existing products, to assess how the pipeline mix evolves.
Key Terms
phase 2b medical
hidradenitis suppurativa medical
efficacy endpoints medical
placebo medical
treatment-emergent adverse event medical
proof-of-concept medical
AI-generated analysis. Not financial advice.
—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—
"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
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) | 0 | 0 |
Serious TEAE, n (%) | 3 (4.1) | 1 (1.4) | 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,
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
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SOURCE Insmed Incorporated