Wednesday, August 02, 2017 5:39:41 AM
The company reported on July 18, 2017, it was notified by the FDA, that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.
http://tradersnewssource.com/aezs/
WHAT IS PDUFA?:
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
BOTTOM LINE: It's going to hit the U.S. market first and soon.
Recent AEZS News
- Aeterna Zentaris Announces Effective Date of Share Consolidation • GlobeNewswire Inc. • 05/01/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Aeterna Zentaris Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Completion of Enrollment in Ongoing Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency • GlobeNewswire Inc. • 03/27/2024 12:05:00 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:53 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Aeterna Zentaris Issues Letter to Shareholders and Management Proxy Circular Ahead of Special Meeting of Shareholders to Approve Merger of Equals with Ceapro • GlobeNewswire Inc. • 02/15/2024 10:50:00 PM
- Form F-1 - Registration statement for certain foreign private issuers • Edgar (US Regulatory) • 02/15/2024 09:54:45 PM
- Form 20-F/A - Annual and transition report of foreign private issuers [Sections 13 or 15(d)]: [Amend] • Edgar (US Regulatory) • 02/15/2024 02:33:18 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 12/22/2023 09:42:20 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/14/2023 12:50:09 PM
- Aeterna Zentaris and Ceapro Announce Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 12/14/2023 12:50:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:28 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:15 PM
- Aeterna Zentaris Reports Third Quarter 2023 Financial Results • GlobeNewswire Inc. • 11/09/2023 01:00:00 PM
- Aeterna Zentaris to Participate at the Virtual Investor Ask the CEO Conference • GlobeNewswire Inc. • 10/11/2023 12:00:00 PM
- Aeterna Zentaris to Present at the H.C. Wainwright 25th Annual Global Investment Conference • GlobeNewswire Inc. • 09/05/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:31 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:18 PM
- Aeterna Zentaris Reports Second Quarter 2023 Financial Results • GlobeNewswire Inc. • 08/09/2023 12:05:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/13/2023 11:30:15 AM
- Aeterna Zentaris Outlines Progress on Development Pipeline Programs and Provides Corporate Update • GlobeNewswire Inc. • 07/13/2023 11:30:00 AM
- Aeterna Zentaris to Participate in the Virtual Investor Summer Spotlight Series • GlobeNewswire Inc. • 07/05/2023 12:45:00 PM
FEATURED POET Announces Design Win and Collaboration with Foxconn Interconnect Technology for High-speed AI Systems • May 14, 2024 10:09 AM
FEATURED Element79 Gold Corp Reports Exceptionally High-Grade Results from Lucero • May 14, 2024 7:00 AM
VAYK Added New Manager for Expansion into $64 Billion Domestic Short-term Rental Market • VAYK • May 14, 2024 9:00 AM
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