Thursday, August 20, 2020 12:09:20 PM
BA Analyst Meachum says we can still see EU
$BMRN
approval in 2020- EMA says 210 days til word on
$BMRN
Hemophilia approval - wow - even with clock stops - any day now : SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ -- “BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. The MAA review will commence in January 2020 under accelerated assessment.
EMA granted access to its Priority Medicines (PRIME) regulatory initiative in 2017 and recently granted BioMarin's request for accelerated assessment of this MAA-This submission marks the first marketing application submission in Europe for a gene therapy product for any type of hemophilia.
Evaluating a MAA under the EMA centralized procedure can take up to 210 days.”
Recent BMRN News
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/10/2024 02:11:12 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/09/2024 02:54:13 PM
- BioMarin to Present at the BofA Securities 2024 Health Care Conference on Wednesday, May 15 at 10:00am PT / 1:00pm ET, in Las Vegas, NV • PR Newswire (US) • 05/08/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/07/2024 09:58:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/06/2024 08:45:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/06/2024 08:40:49 PM
- New Data for BioMarin's VOXZOGO® (vosoritide) for Multiple Growth-Related Conditions in Children Presented at Pediatric Endocrine Society (PES) Annual Meeting • PR Newswire (US) • 05/04/2024 08:00:00 PM
- BioMarin Reports Record Financial Results for the First Quarter 2024 • PR Newswire (US) • 04/24/2024 08:03:00 PM
- BioMarin to Host First Quarter 2024 Financial Results Conference Call and Webcast on Wednesday, April 24, 2024, at 4:30pm ET • PR Newswire (US) • 04/10/2024 12:00:00 PM
- New Data to be Presented for BioMarin's VOXZOGO® (vosoritide) in Children with Hypochondroplasia and Achondroplasia at the American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting • PR Newswire (US) • 03/12/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 11:54:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 10:35:37 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 10:32:40 PM
- BioMarin Announces Appointment of Cristin Hubbard as Chief Commercial Officer • PR Newswire (US) • 03/07/2024 01:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/06/2024 05:04:50 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/05/2024 09:17:10 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/05/2024 07:41:36 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/05/2024 05:04:02 PM
- BioMarin Scheduled to Participate in March Investor Conferences • PR Newswire (US) • 03/01/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:18:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:16:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:14:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:12:37 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:10:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:05:21 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