Insmed Inc. (INSM) is having a moment. The respiratory-focused biotech rolled out its 2026 roadmap on Friday, and the story is pretty straightforward: a newly approved lung disease drug is gaining serious commercial traction, the existing revenue driver keeps performing, and a packed pipeline could deliver multiple catalysts over the next 18 months.

Speaking ahead of the company's presentation at the J.P. Morgan Healthcare Conference, Chair and CEO Will Lewis described 2025 as a turning point where scientific progress finally translated into commercial execution. That's biotech-speak for "we're actually making money now."

Brinsupri's Launch Momentum

The headline here is Brinsupri, which pulled in preliminary revenues of $172.7 million for full-year 2025 and roughly $144.6 million in its first full quarter post-launch following FDA approval in August. That's a pretty strong start for a drug treating non-cystic fibrosis bronchiectasis in patients 12 years and older.

By the end of 2025, about 4,000 healthcare providers had prescribed the therapy, and approximately 9,000 new patients initiated treatment in the fourth quarter alone. Those numbers suggest real demand, not just early adopter enthusiasm.

Brinsupri also secured European Commission approval in November 2025 for the same indication in patients aged 12 and up. Insmed plans to launch the drug across the European Union in the first half of 2026, with additional rollouts expected in the U.K. and Japan pending regulatory clearance.

Arikayce Continues Delivering

While Brinsupri grabs the spotlight, Arikayce remains the steady moneymaker. The company is projecting 2026 global sales between $450 million and $470 million for the established therapy. For context, preliminary 2025 sales came in at approximately $433.8 million, which should exceed the upper end of guidance.

What's Coming Next

The clinical calendar is packed. Insmed expects topline results from the Phase 3 ENCORE trial of Arikayce in newly diagnosed or recurrent mycobacterium avium complex lung disease patients by March or April 2026. A positive outcome would trigger a supplemental NDA submission to the FDA in the second half of the year, potentially expanding Arikayce's U.S. label.

The pipeline extends beyond respiratory diseases. The company initiated a Phase 3 trial of treprostinil palmitil inhalation powder (TPIP) in PH-ILD in late 2025 and plans to start a Phase 3 PAH study in early 2026, with additional fibrosis studies coming later in the year.

Brensocatib, the active ingredient in Brinsupri, is also being tested in hidradenitis suppurativa, with Phase 2b CEDAR study data expected in the second quarter of 2026. Meanwhile, INS1033 is being prepared for an IND filing in inflammatory diseases.

The neuro pipeline includes the Phase 1 ASCEND trial of an intrathecal gene therapy for Duchenne muscular dystrophy, the Phase 1 ARMOR study of INS1202 for amyotrophic lateral sclerosis, and a preclinical Stargardt disease program, with an IND filing planned for 2026.

Insmed says its preclinical engine encompasses more than 30 programs, with plans to file one to two INDs annually while keeping preclinical spending below 20% of total expenditures. That's a lot of shots on goal without breaking the budget.

Not Everything Works

Of course, drug development doesn't always cooperate. In December 2025, the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps failed to meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. That's the reality of biotech—you win some, you lose some.

Price Action: Insmed stock was up 2.92% at $175.24 at publication on Friday.