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Insmed Ends Brinsupri Development in Skin Disease Post Study Failure
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Key Takeaways
Insmed halts Brinsupri HS program after phase IIb CEDAR study missed key endpoints.
INSM data showed placebo beat drug in reducing abscess and nodule counts in HS patients.
Brinsupri remains approved for non-CF bronchiectasis with strong early sales and EU expansion.
Insmed (INSM - Free Report) announced that it is discontinuing the development of Brinsupri (brensocatib) for hidradenitis suppurativa (HS) following disappointing mid-stage study results.
The decision comes after data from the phase IIb CEDAR study, which evaluated the drug in adults with moderate-to-severe HS. The study failed to meet both its primary and secondary efficacy endpoints, with results notably favoring placebo over treatment.
Patients treated with 10 mg and 40 mg doses of Brinsupri achieved 45.5% and 40.3% reductions, respectively, in total abscess and inflammatory nodule (AN) count — a key measure of disease severity in HS. In comparison, the placebo group saw a greater reduction of 57.1%, indicating a lack of meaningful clinical benefit from the drug in this indication. Insmed reported no safety concerns in the study.
HS is a chronic, non-contagious inflammatory skin condition marked by painful, recurring, pea-sized lumps, abscesses and tunnels beneath the skin, often leaving scars.
This marks another setback for Insmed’s efforts to expand Brinsupri’s label. In December, the drug failed a mid-stage study that evaluated it for chronic rhinosinusitis without nasal polyps (CRSsNP), which had already raised concerns about its efficacy beyond its approved indication.
Insmed achieved a significant milestone with Brinsupri in August 2025, when the FDA approved it as the first treatment for non-cystic fibrosis (non-CF) bronchiectasis. Following this approval, the drug became the second marketed product in Insmed’s portfolio after Arikayce (approved to treat a rare lung disease infection).
INSM Stock Performance
Shares of Insmed have underperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
More on Insmed’s Brinsupri
Early commercial traction for Brinsupri has been encouraging — the drug generated about $173 million in 2025 sales despite receiving approval only in mid-August 2025, reflecting strong initial uptake.
Momentum could further build following the recent EU approval, which significantly broadens Brinsupri’s commercial footprint. A regulatory filing for the drug is currently under review in Japan — a region where an estimated 150,000 people are diagnosed with non-CF bronchiectasis.
Insmed expects Brinsupri to achieve blockbuster status this year.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has risen about 1% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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Insmed Ends Brinsupri Development in Skin Disease Post Study Failure
Key Takeaways
Insmed (INSM - Free Report) announced that it is discontinuing the development of Brinsupri (brensocatib) for hidradenitis suppurativa (HS) following disappointing mid-stage study results.
The decision comes after data from the phase IIb CEDAR study, which evaluated the drug in adults with moderate-to-severe HS. The study failed to meet both its primary and secondary efficacy endpoints, with results notably favoring placebo over treatment.
Patients treated with 10 mg and 40 mg doses of Brinsupri achieved 45.5% and 40.3% reductions, respectively, in total abscess and inflammatory nodule (AN) count — a key measure of disease severity in HS. In comparison, the placebo group saw a greater reduction of 57.1%, indicating a lack of meaningful clinical benefit from the drug in this indication. Insmed reported no safety concerns in the study.
HS is a chronic, non-contagious inflammatory skin condition marked by painful, recurring, pea-sized lumps, abscesses and tunnels beneath the skin, often leaving scars.
This marks another setback for Insmed’s efforts to expand Brinsupri’s label. In December, the drug failed a mid-stage study that evaluated it for chronic rhinosinusitis without nasal polyps (CRSsNP), which had already raised concerns about its efficacy beyond its approved indication.
Insmed achieved a significant milestone with Brinsupri in August 2025, when the FDA approved it as the first treatment for non-cystic fibrosis (non-CF) bronchiectasis. Following this approval, the drug became the second marketed product in Insmed’s portfolio after Arikayce (approved to treat a rare lung disease infection).
INSM Stock Performance
Shares of Insmed have underperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
More on Insmed’s Brinsupri
Early commercial traction for Brinsupri has been encouraging — the drug generated about $173 million in 2025 sales despite receiving approval only in mid-August 2025, reflecting strong initial uptake.
Momentum could further build following the recent EU approval, which significantly broadens Brinsupri’s commercial footprint. A regulatory filing for the drug is currently under review in Japan — a region where an estimated 150,000 people are diagnosed with non-CF bronchiectasis.
Insmed expects Brinsupri to achieve blockbuster status this year.
INSM’s Zacks Rank
Insmed currently carries a Zacks Rank #3 (Hold).
Insmed, Inc. Price
Insmed, Inc. price | Insmed, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy) at present, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has risen about 1% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.