Zacks Investment Research·1d ago
FDA Accepts Insmed's Filing Seeking Label Expansion for ArikayceINSM's Arikayce label expansion gets FDA priority review, potentially broadening its use in newly diagnosed MAC lung disease.
Insmed's Q2 2026 revenue surged 66.7% YoY to $425.5M, driving gross margin to 84.2% and narrowing operating loss to just -$1.5M, signaling a potential commercial inflection for ARIKAYCE. However, the company remains deeply unprofitable with cumulative net loss...
Price trend, volume and key moving averages
Start with the evidence for owning the stock and the risks that can break the thesis.
Revenue accelerated 66.7% YoY to $425.5M in Q2 2026 with gross margin expanding to 84.2%, yet operating income remained slightly negative at -$1.5M, reflecting heavy R&D and SG&A investment of $457.5M.
Brensocatib's FDA approval in February 2026 and Q1/2026 sales exceeding expectations by 2× validate the bullish investment thesis.
Encouraging post-hoc Phase III data for Brinsupri, a first-to-market DPP-1 inhibitor, presented at the American Thoracic Society conference strengthens the bull case.
Insmed's grant of inducement stock awards to 103 new employees under its 2025 Inducement Plan signals growth and commitment to scaling operations.
Trailing total returns as of 9/24/2026, which may include dividends or other distributions. Benchmark is S&P 500 (^GSPC).
Recent results and news deserve attention only when they alter the forward view.
| Quarter | EPS (Act vs Est) | Revenue (Act vs Est) |
|---|---|---|
Q3 2026Latest Aug 6, 2026 | -$0.06+91.1% vs -$0.67 | $425M+7.6% vs $395M |
Q2 2026 May 7, 2026 | -$0.76+21.1% vs -$0.96 | $306M+1.7% vs $301M |
Q1 2026 Feb 19, 2026 | -$1.54-43.9% vs -$1.07 | $264M+14.1% vs $231M |
Q4 2025 Oct 30, 2025 | -$1.75-31.6% vs -$1.33 | $142M+23.3% vs $115M |
INSM's Arikayce label expansion gets FDA priority review, potentially broadening its use in newly diagnosed MAC lung disease.
Insmed is rated Buy, driven by Brinsupri's blockbuster launch and strong TPIP Phase 2b data. Brinsupri generated $517m in 1H 2026, faces minimal competition, and targets $7bn+ peak sales with COPD/asthma comorbidity upside. TPIP's Phase 2b results exceeded expectations; four Phase 3 indications could yield $6bn+ peak sales if approved.
—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study— —Full Approval Could Bring ARIKAYCE to Patients Earlier in Their Disease Course and Would Fulfill Post-Marketing Requirement From FDA— BRIDGEWATER, N.J., Sept. 21, 2026 /PRNewswire/ -- 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 U.S. Food and Drug Administration (FDA) has accepted the Company's Supplemental New Drug Application (sNDA) for review of ARIKAYCE® (amikacin liposome inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen.
Company-wide day of service brings together more than 1,350 employees to support over 50 organizations throughout the U.S., Europe, and Japan BRIDGEWATER, N.J., Sept. 16, 2026 /PRNewswire/ -- 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 holds its fifth annual Global Day of Good, a company-wide day of service during which employees volunteer simultaneously in their respective communities around the world.
Benchmark INSM against direct peers instead of judging its metrics in isolation.
Key metrics vs top competitors for Insmed Incorporated (INSM)
| Company | Price | Market Cap | P/E Ratio | Rev Growth (1Y) | Net Margin | ROE | Div Yield |
|---|---|---|---|---|---|---|---|
| $118.34 | $25.65B | -18.46 | 66.73% | -210.54% | -249.28% | — | |
| $14.88 | $1.47B | -2.55 | 20.13% | -81.79% | — | — | |
| $246.51 | $32.91B | 105.80 | 65.19% | 16.82% | 93.61% | — | |
| $62.21 | $12.02B | 34.56 | 12.87% | 2.14% | 1.18% | — | |
| $18.95 | $2B | -2.66 | 15.58% | -6.93% | -9.96% | — | |
| $43.93 | $7.3B | -18.46 | 33.87% | -64.64% | -110.84% | — |
Insmed Incorporated (INSM) vs competitors — business, growth, and fundamentals comparison against the closest industry rivals.
Verify the primary filings, follow material updates, and answer the remaining questions.
Insmed Incorporated (INSM) SEC filings — annual & quarterly reports (10-K, 10-Q)
Aug 6, 2026·SEC
Jul 16, 2026·SEC
May 15, 2026·SEC
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Insmed Incorporated (INSM) stock FAQ — growth, dividends, profitability & financials explained
Insmed Incorporated (INSM) reported $1.14B in revenue for fiscal year 2025. This represents a 113763400% increase from $0.0M in 1999.
Insmed Incorporated (INSM) grew revenue by 66.7% over the past year. This is strong growth.
Insmed Incorporated (INSM) reported a net loss of $875.3M for fiscal year 2025.
Insmed Incorporated (INSM) has a return on equity (ROE) of -249.3%. Negative ROE indicates the company is unprofitable.
Insmed Incorporated (INSM) had negative free cash flow of $837.7M in fiscal year 2025, likely due to heavy capital investments.
