Insmed (INSM) Up on Positive Data From MAC Lung Disease Study
Insmed Incorporated's INSM shares were up 16% on Sep 05, as it announced positive data from the ARISE study, evaluating Arikayce for newly infected lung disease caused by a group of bacteria called Mycobacterium avium complex (MAC).
The patients enrolled in the study had newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by MAC and had not yet started antibiotics treatment.
The phase III ARISE study achieved its primary objective which showed that the Quality of Life – Bronchiectasis (QOL-B) respiratory domain serves as an efficient patient-reported measure (PRO) for individuals suffering from MAC lung disease.
Data from the study showed that almost 43.8% of patients with NTM lung infection saw an improvement in QOL-B respiratory symptoms after receiving Arikayce treatment compared with 33.3% in the placebo group. Additionally, after seven months of Arikayce treatment, a higher proportion of patients treated tested negative for the bacteria compared to those in the placebo arm.
Based on the results of ARISE, Insmed plans to explore with global regulators to accelerate the filing for approval of Arikayce in newly infected patients with MAC lung disease.
Insmed’s lead drug Arikayce received accelerated approval by the FDA to treat patients with refractory MAC lung disease who have limited or no alternative treatment options. It is the first and only therapy approved for the treatment of MAC lung disease in the United States.
The ARISE and another study on Arikayce called ENCORE are confirmatory studies being conducted to get the accelerated approval converted to full approval.
Shares of Insmed have rallied 13.3% year to date against the industry’s 11.9% decline.
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Based on the above findings, Insmed plans to urge the FDA to make the QOL-B respiratory domain PRO the primary endpoint for the ongoing ENCORE study, without any modifications. This proposal is significant as there are currently no established clinical endpoints to evaluate the benefits of treatment in patients with MAC lung disease.
Arikayce has been witnessing strong sales uptake in the United States since its launch. The drug generated revenues of $142.4 million in the first half of 2023, implying year-over-year growth of 20%.
Insmed, Inc. Price and Consensus
Insmed, Inc. price-consensus-chart | Insmed, Inc. Quote
Zacks Rank & Stocks to Consider
Insmed currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are ANI Pharmaceuticals ANIP, Annovis Bio ANVS and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 60.5% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 8.1% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 62.9% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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