Insmed Trading Resumes: Investing with Confidence

Insmed trading has resumed after being halted earlier.

Insmed Incorporated (NASDAQ: INSM) has resumed trading after its stock was halted earlier in the day. The trading halt was prompted by the company's announcement of the Food and Drug Administration (FDA) approval of Brinsupri, a once-daily oral medicine designed to treat non-cystic fibrosis bronchiectasis (NCFB).

The FDA's approval of Brinsupri marks a significant milestone for Insmed, as it is the first drug to treat NCFB and the first in a new class of drugs called DPP-1 inhibitors. The approval is based on successful Phase 3 ASPEN and Phase 2 WILLOW studies, which demonstrated a reduction in annual exacerbations by 21.1% for the 10 mg dosage and 19.4% for the 25 mg dosage compared to a placebo [2].

The FDA's approval of Brinsupri is expected to drive significant market potential for Insmed. Wall Street analysts forecast as much as $6 billion in annual sales for the drug, with Insmed's market valuation swelling to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce, and pipeline candidates in lung disease and Duchenne muscular dystrophy [1].

Following the FDA's approval, Insmed's stock price hit a yearly high of $122.01, reflecting positive investor sentiment and the company's strong market capitalization of approximately $25.79 billion [3]. RBC Capital has upgraded Insmed to "Outperform" with a new price target of $138, citing the drug's significant efficacy and market potential [3].

Insmed plans to charge $88,000 a year for Brinsupri at list price, with an estimated net price of 25% to 35% lower after accounting for rebates and discounts provided to insurers. The drug's safety cautions were limited to skin and mouth side effects and use with live vaccines, which are manageable limitations [1].

Bronchiectasis affects an estimated 500,000 people in the U.S., with the condition often resulting from tissue damage caused by infections. The FDA's approval of Brinsupri provides a much-needed therapeutic option for patients with NCFB [1].

References:
[1] https://www.biopharmadive.com/news/insmed-fda-approval-brinsupri-brensocatib-bronchiectasis/757476/
[2] https://seekingalpha.com/news/4484032-insmed-stock-rises-fda-nod-for-lung-disorder-drug-brinsupri
[3] https://site.financialmodelingprep.com/market-news/insmed-nasdaq-insm-upgraded-rbc-capital-fda-approval