Key Takeaways
- Insmed shares more than doubled in value Tuesday after the company reported positive results for a Phase 3 study of its experimental drug to treat symptoms in patients with a rare lung disease.
- The biopharmaceutical firm said its treatment brensocatib significantly reduced pulmonary exacerbations for those suffering from non-cystic fibrosis bronchiectasis.
- Insmed said it will apply for Food and Drug Administration approval in the fourth quarter, and hopes to have brensocatib on the market by mid-2025.
Insmed (INSM) shares more than doubled in value Tuesday after the biopharmaceutical company announced positive results in a late-stage study of its experimental drug to reduce symptoms in patients with a rare lung disease.
The company said its Phase 3 trial of brensocatib demonstrated statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) for those suffering from non-cystic fibrosis bronchiectasis. PEs generally cause an increase in respiratory problems such as coughing and shortness of breath, as well as a decrease in lung function.
Treatment ‘Could Offer a Completely New Approach’
Lead study investigator James Chalmers noted that there is an urgent need for a therapy that can reduce PEs for people with bronchiectasis, and that brensocatib “could offer a completely new approach to managing this difficult-to-treat patient population.”
Plans To Apply for FDA Approval
Insmed said that based on these results, it plans to file an application in the fourth quarter with the Food and Drug Administration (FDA) for use of brensocatib in patients with bronchiectasis. It added that pending that approval, it hopes to have the medicine on the market in mid-2025, followed by launches in Europe and Japan in the first half of 2026.
Shares of Insmed more than doubled Tuesday to close at $48.06 per share. With Tuesday’s news, they’ve advanced over 55% since the start of the year.
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