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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Insmed Inc | NASDAQ:INSM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
1.36 | 1.99% | 69.79 | 68.90 | 70.90 | 70.65 | 68.75 | 69.54 | 3,882,243 | 23:44:39 |
(State or other jurisdiction of incorporation)
|
(Commission File Number)
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(IRS Employer Identification No.)
|
|
(Zip Code)
|
|
(Address of principal executive offices)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which
registered
|
|
|
|
Brensocatib 10 mg
compared to placebo
|
Brensocatib 25 mg
compared to placebo
|
Primary Endpoint
|
Reduction in annualized rate of PEs
|
21.1%
|
p=0.0019*
|
19.4%
|
p=0.0046*
|
|||||
Secondary Endpoints
|
|||||||||
Prolongation of time to first PE
|
18.7%
|
p=0.0100*
|
17.5%
|
p=0.0182*
|
|||||
Increase in odds of remaining exacerbation free over 52 weeks
|
41.2%
|
p=0.0059*
|
40.0%
|
p=0.0074*
|
|||||
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at week 52
|
11 mL
|
p=0.3841
|
38 mL
|
p=0.0054*
|
|||||
Reduction in annualized rate of severe PEs
|
25.8%
|
p=0.1277
|
26.0%
|
p=0.1025
|
|||||
Change from baseline in the Quality of Life – Bronchiectasis (QOL-B) Respiratory Score at week 52
|
2.0 points
|
p=0.0594
|
3.8 points
|
p=0.0004^
|
Brensocatib 10 mg
(n=582)
|
Brensocatib 25 mg
(n=574)
|
Placebo
(n=563)
|
|||||
Any TEAE, n (%)
|
452 (77.7)
|
440 (76.7)
|
448 (79.6)
|
||||
Severe TEAE, n (%)
|
74 (12.7)
|
67 (11.7)
|
90 (16.0)
|
||||
Serious TEAE, n (%)
|
101 (17.4)
|
97 (16.9)
|
108 (19.2)
|
||||
TEAE leading to death, n (%)
|
3 (0.5)
|
4 (0.7)
|
7 (1.2)
|
||||
TEAE leading to treatment discontinuation, n (%)
|
25 (4.3)
|
22 (3.8)
|
23 (4.1)
|
||||
TEAESIs, n (%)
|
42 (7.2)
|
56 (9.8)
|
53 (9.4)
|
||||
Hyperkeratosis, n (%)
|
8 (1.4)
|
17 (3.0)
|
4 (0.7)
|
||||
Periodontal/gingival event, n (%)
|
8 (1.4)
|
12 (2.1)
|
15 (2.7)
|
||||
Severe infection, n (%)
|
4 (0.7)
|
7 (1.2)
|
4 (0.7)
|
||||
Pneumonia, n (%)
|
23 (4.0)
|
27 (4.7)
|
33 (5.9)
|
Exhibit
No.
|
Description
|
|
Press release issued by Insmed Incorporated on May 28, 2024.
|
||
Insmed Incorporated May 28, 2024 ASPEN Presentation.
|
||
104
|
Cover Page Interactive Date File (embedded within the Inline XBRL document).
|
Dated: May 28, 2024
|
INSMED INCORPORATED
|
|
By:
|
/s/ Michael A. Smith
|
|
Name:
|
Michael A. Smith
|
|
Title:
|
Chief Legal Officer and Corporate Secretary
|
Brensocatib 10 mg
compared to placebo
|
Brensocatib 25 mg
compared to placebo
|
Primary Endpoint
|
Reduction in annualized rate of PEs
|
21.1%
|
p=0.0019*
|
19.4%
|
p=0.0046*
|
|||||
Secondary Endpoints
|
|||||||||
Prolongation of time to first PE
|
18.7%
|
p=0.0100*
|
17.5%
|
p=0.0182*
|
|||||
Increase in odds of remaining exacerbation free over 52 weeks
|
41.2%
|
p=0.0059*
|
40.0%
|
p=0.0074*
|
|||||
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at week 52
|
11 mL
|
p=0.3841
|
38 mL
|
p=0.0054*
|
|||||
Reduction in annualized rate of severe PEs
|
25.8%
|
p=0.1277
|
26.0%
|
p=0.1025
|
|||||
Change from baseline in the Quality of Life – Bronchiectasis (QOL-B) Respiratory Score at week 52
|
2.0 points
|
p=0.0594
|
3.8 points
|
p=0.0004^
|
Brensocatib 10 mg
(n=582)
|
Brensocatib 25 mg
(n=574)
|
Placebo
(n=563)
|
|||||
Any TEAE, n (%)
|
452 (77.7)
|
440 (76.7)
|
448 (79.6)
|
||||
Severe TEAE, n (%)
|
74 (12.7)
|
67 (11.7)
|
90 (16.0)
|
||||
Serious TEAE, n (%)
|
101 (17.4)
|
97 (16.9)
|
108 (19.2)
|
||||
TEAE leading to death, n (%)
|
3 (0.5)
|
4 (0.7)
|
7 (1.2)
|
||||
TEAE leading to treatment discontinuation, n (%)
|
25 (4.3)
|
22 (3.8)
|
23 (4.1)
|
||||
TEAESIs, n (%)
|
42 (7.2)
|
56 (9.8)
|
53 (9.4)
|
||||
Hyperkeratosis, n (%)
|
8 (1.4)
|
17 (3.0)
|
4 (0.7)
|
||||
Periodontal/gingival event, n (%)
|
8 (1.4)
|
12 (2.1)
|
15 (2.7)
|
||||
Severe infection, n (%)
|
4 (0.7)
|
7 (1.2)
|
4 (0.7)
|
||||
Pneumonia, n (%)
|
23 (4.0)
|
27 (4.7)
|
33 (5.9)
|
Document and Entity Information |
May 28, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 28, 2024 |
Entity File Number | 000-30739 |
Entity Registrant Name | INSMED INCORPORATED |
Entity Central Index Key | 0001104506 |
Entity Incorporation, State or Country Code | VA |
Entity Tax Identification Number | 54-1972729 |
Entity Address, Address Line One | 700 US Highway 202/206 |
Entity Address, City or Town | Bridgewater |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08807 |
City Area Code | 908 |
Local Phone Number | 977-9900 |
Title of 12(b) Security | Common Stock, par value $0.01 per share |
Trading Symbol | INSM |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
1 Year Insmed Chart |
1 Month Insmed Chart |
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