Wednesday, June 18, 2014 7:47:39 AM
8k :
Item 8.01. Other Events.
Insmed Incorporated (the “Company”) announced today that the U.S. Food and Drug Administration (the “FDA”) granted ARIKAYCE™, or liposomal amikacin for inhalation, Breakthrough Therapy Designation for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease who are treatment refractory. This designation is based on findings from the Company’s U.S. phase 2 clinical trial of ARIKAYCE to treat NTM lung infections. The Company has plans to meet with the FDA to discuss the regulatory pathway for ARIKAYCE.
Recent INSM News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 11:05:02 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 11:00:30 AM
- Insmed Reports First-Quarter 2024 Financial Results and Provides Business Update • PR Newswire (US) • 05/09/2024 11:00:00 AM
- Insmed To Present at the BofA Securities Health Care Conference 2024 • PR Newswire (US) • 05/07/2024 12:00:00 PM
- Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • PR Newswire (US) • 05/03/2024 12:00:00 PM
- Insmed to Host First-Quarter 2024 Financial Results Conference Call on Thursday, May 9, 2024 • PR Newswire (US) • 04/25/2024 12:00:00 PM
- Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • PR Newswire (US) • 04/05/2024 12:00:00 PM
- Insmed to Present New Data from Across its Respiratory Portfolio at the American Thoracic Society 2024 International Conference • PR Newswire (US) • 03/27/2024 08:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/11/2024 01:27:59 PM
- Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • PR Newswire (US) • 03/05/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 09:08:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 09:05:35 PM
- Insmed To Present at Three March Conferences • PR Newswire (US) • 02/29/2024 01:00:00 PM
- Actress Jane Seymour and Insmed Raise Awareness of "Unseenism" and Empower People to Speak Up When It Comes to Their Health • PR Newswire (US) • 02/28/2024 09:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/22/2024 12:58:04 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/22/2024 12:43:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/22/2024 12:00:23 PM
- Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update • PR Newswire (US) • 02/22/2024 12:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/16/2024 10:43:57 PM
- Insmed to Host Fourth-Quarter and Full Year 2023 Financial Results Conference Call on Thursday, February 22, 2024 • PR Newswire (US) • 02/08/2024 01:00:00 PM
- Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • PR Newswire (US) • 02/02/2024 09:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 09:06:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 09:05:32 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM