RBC Capital Markets has initiated protection on Insmed Inc INSM, citing brensocatib’s launch momentum.
In February, the FDA accepted the corporate’s New Drug Software (NDA) for brensocatib for sufferers with bronchiectasis and granted the appliance Precedence Evaluation with a Prescription Drug Consumer Price Act goal motion date of August 12, 2025.
If permitted, Insmed expects brensocatib to launch within the U.S. within the third quarter.
The FDA additionally knowledgeable the corporate that it doesn’t at present plan to carry an advisory committee assembly to debate the New Drug Software.
RBC Capital analyst Leonid Timashev says brensocatib has potential for a $6.5 billion alternative in bronchiectasis and a speedy launch, “making Insmed a sexy midcap biotech.”
RBC has initiated with an Outperform ranking with a value forecast of $100.
The RBC analyst expects a excessive probability of approval for the bronchiectasis remedy with a positive label, paving the best way for a robust launch. Suggestions from key opinion leaders (KOLs) and the corporate’s prelaunch efforts and schooling suggests a robust willingness to prescribe. Round 50% or extra of eligible sufferers might obtain brensocatib after its mid-2025 launch.
Whereas insurance coverage protection and reaching average sufferers could pose early challenges, frequent affected person visits, optimistic preliminary experiences, and being the one permitted remedy ought to drive adoption and protection. Previous respiratory drug launches (bronchial asthma, COPD) have carried out nicely.
RBC says Arikayce, an antibiotic, continues to generate regular income and has sturdy potential for a serious label enlargement if the Part 3 ENCORE examine delivers optimistic leads to 2026. Leonid Timashev estimates peak gross sales might attain $1 billion, valuing Arikayce at as much as $25 per share.
Final week, Insmed reported a fourth-quarter lack of $1.32 per share, lacking the consensus lack of $1.17. Gross sales reached $104.4 million, beating the consensus of $101.79 million.
Insmed anticipates full-year 2025 international Arikayce income of $405 million-$425 million, up 11%-17% yr over yr.
Value Motion: INSM inventory closed down by 3.17% to $77.49 on the final examine Tuesday.
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