Insmed’s INSM shares have surged 78% over the past six months, driven by strong momentum around its late-stage pipeline and robust sales from its marketed drugs, boosting investor confidence.
The primary catalyst was the FDA approval of brensocatib under the brand name ‘Brinsupri’ in the United States in August 2025. Brinsupri became the first approved therapy for patients with non-cystic fibrosis bronchiectasis (NCFB). The drug secured a similar approval in the European Union in November 2025.
The approval not only positions Insmed to tap into a multi-billion-dollar market but also marks the company’s second marketed product. Despite receiving approval in August, Brinsupri generated revenues of $28.1 million in the third quarter, driven by strong patient uptake.
Brinsupri’s initial launch uptake seems to have reinforced investor confidence in its strong revenue potential, which helped push the stock price higher.
Over the past year, shares of Insmed have surged 149.2% against the industry’s 17.5% growth.
Image Source: Zacks Investment ResearchConcurrently, Insmed’s established product, Arikayce, continues to generate steady revenues, helping to reduce near-term cash flow concerns while the company advances its pipeline.
Arikayce, approved for the treatment of refractory mycobacterium avium complex (MAC) lung disease, recorded product sales of $314.5 million in the first nine months of 2025, reflecting 21% year over year, driven by sustained demand across all marketed regions.
Following the third-quarter release in November, Insmed raised its full-year guidance for global Arikayce revenues. The company now expects 2025 revenues in a range of $420 million to $430 million, up from the prior range of $405 million to $425 million, reflecting continued double-digit growth compared with 2024.
Insmed, however, faced a setback last month, after its phase IIb BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps (CRSsNP) failed to meet key efficacy goals, leading the company to discontinue development in this indication. Shares declined following the announcement amid high investor expectations from this study.
Despite this setback, Insmed continues to strengthen its pipeline. In December the company added INS1148, a monoclonal antibody acquired from Opsidio, which will initially be developed in mid-stage studies for the treatment of interstitial lung disease and moderate-to-severe asthma.
Insmed is also evaluating brensocatib in the phase II CEDAR study for patients with hidradenitis suppurativa (HS) indication, with top-line data expected in the first half of 2026.
Additionally, Insmed is evaluating Arikayce in newly infected patients with MAC lung disease under the phase III ENCORE study. The company expects positive data from the study in early 2026 and plans to file a supplementary new drug application later in the year. If approved by the FDA, the label expansion would expand the drug’s eligible patient population and support additional sales.
Insmed is also progressing treprostinil palmitil inhalation powder into late-stage studies for pulmonary hypertension indications.
Insmed, Inc. Price
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INSM’s Zacks Rank & Stocks to Consider
Insmed currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD, and Castle Biosciences CSTL, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 adjusted EPS have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 42.2% over the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD surged 42.5% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, the 2025 loss per share estimate for Castle Biosciences has narrowed to 34 cents from 64 cents. Over the same period, loss per share estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 36% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.
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Insmed, Inc. (INSM): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report CorMedix Inc (CRMD): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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