Tuesday, March 31, 2020 7:46:04 AM
Read between the lines. The pop is coming.
RESEARCH TRIANGLE PARK, N.C., March 30, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) submission for approval of oral, once-daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.
With this validation, the EMA has begun their formal review of the MAA under the centralized procedure for all member states of the European Union, and Norway, Iceland and Liechtenstein.
An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected within approximately 12 months.
“Berotralstat would represent the first targeted oral therapy approved for HAE prophylaxis in Europe and would deliver a major advance in therapy to HAE patients,” said Jon Stonehouse, chief executive officer of BioCryst.
“HAE treatment in Europe tends to be consolidated and we have developed excellent relationships with HAE-treating physicians through our clinical trials. This is allowing us to build an efficient and experienced European commercial team to bring our innovative medicine to patients,” Stonehouse added.
BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. The U.S. Food and Drug Administration (FDA) is currently reviewing a new drug application for berotralstat and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA). In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new drug application (JNDA) for berotralstat under the Sakigake timeline, and the company expects Japanese approval in the second half of 2020.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.
Recent BCRX News
- BioCryst Presents New Real-world Evidence Showing Significant Reductions in Healthcare Resource Utilization Among Patients with HAE Following Initiation of ORLADEYO® (berotralstat) • GlobeNewswire Inc. • 05/09/2024 11:00:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/07/2024 08:02:30 PM
- BioCryst to Present at Upcoming Investor Conferences • GlobeNewswire Inc. • 05/07/2024 11:00:22 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 11:03:00 AM
- BioCryst Reports First Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/06/2024 11:00:00 AM
- BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 05/03/2024 11:00:07 AM
- BioCryst to Report First Quarter 2024 Financial Results on May 6 • GlobeNewswire Inc. • 04/22/2024 11:00:50 AM
- BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Brazilian Health Regulatory Agency • GlobeNewswire Inc. • 04/17/2024 08:30:39 AM
- BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 04/03/2024 11:00:23 AM
- BioCryst to Present at Upcoming Investor Conferences • GlobeNewswire Inc. • 03/25/2024 08:01:00 PM
- BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 03/05/2024 12:01:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 10:25:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 09:32:01 PM
- Form S-3ASR - Automatic shelf registration statement of securities of well-known seasoned issuers • Edgar (US Regulatory) • 02/27/2024 10:05:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/26/2024 12:05:56 PM
- BioCryst Reports Fourth Quarter and Full Year 2023 Financial Results and Upcoming Key Milestones • GlobeNewswire Inc. • 02/26/2024 12:00:05 PM
- U.S. Index Futures Dip Amid Inflation Data Anticipation, Oil and Iron Ore Prices Retreat • IH Market News • 02/26/2024 10:57:28 AM
- BioCryst Presents New Real-world Data Showing Rapid, Substantial and Sustained HAE Attack Rate Reductions After Beginning ORLADEYO® (berotralstat) Treatment • GlobeNewswire Inc. • 02/23/2024 12:00:00 PM
- BioCryst to Present at Upcoming Investor Conferences • GlobeNewswire Inc. • 02/21/2024 09:01:58 PM
- BioCryst Launches ORLADEYO® (berotralstat) in Italy • GlobeNewswire Inc. • 02/19/2024 12:54:52 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 09:21:51 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 02:02:50 PM
- BioCryst to Report Fourth Quarter 2023 Financial Results on February 26 • GlobeNewswire Inc. • 02/12/2024 12:00:53 PM
- BioCryst to Present New ORLADEYO® (berotralstat) Real-world Data at 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting • GlobeNewswire Inc. • 02/05/2024 12:00:00 PM
- BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 02/02/2024 12:00:48 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