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Thursday, July 23, 2015 9:11:10 AM
Aeterna Zentaris is certainly the Speculator.
Summary:
Aeterna Zentaris is a specialty biopharmaceutical company, engaged in the development and commercialization of novel treatments in oncology, endocrinology, and women's health. The company’s product pipeline includes MACRILEN, which completed the Phase 2 trial for use in the diagnosis of adult growth hormone deficiency; and zoptarelin doxorubicin, which is in Phase 3 clinical study in endometrial cancer (ZoptEC) of the compound in women with advanced, recurrent, or metastatic endometrial cancer. It is also developing two oncology compounds, including an Erk inhibitor and luteinizing hormone-releasing hormone-disorazol Z product candidates, which are in pre-clinical development.
Recent News and Analysis
The company recently announced it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer. The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival. Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016. In addition to the developments in ZoptEC, the company has three drug candidates in pre-clinical studies, and has moved Macrilen into Phase 3 trials for the evaluation of adult growth hormone deficiency.
Shares of AEZS have retreated dramatically over the past year, falling from a high of $1.54 to as low as $0.20. The drop started when Aeterna Zentaris’ Macrilen drug was not approved by the FDA in Nov 2014. Shares of AEZS have been falling ever since. It is believed the company has reached a bottom and should begin an upward trend. This, of course, is with the assumption that the ZoptEC trials are successful and obtain approval in the future. Chances of this appear higher as it was last reported that the analysis of the drug by the FDA recommended continuing with the next set of trials.
Verdict
AEZS is certainly the speculator in this trio of companies. It is trading at a significant discount to the 52 – week high and certainly has the potential to reach those levels again. However, success rides heavily on the success of the Phase 3 trials for ZoptEC. If unsuccessful in Phase 3 trials, the company does have several more drug candidates which it can continue to develop and hope for a home run.
Recent AEZS News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/13/2024 01:20:29 PM
- Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency • GlobeNewswire Inc. • 06/13/2024 01:10:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/10/2024 05:31:28 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 06/06/2024 05:46:51 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 06/05/2024 04:15:07 AM
- Aeterna Zentaris and Ceapro Complete Merger Transaction • GlobeNewswire Inc. • 06/03/2024 01:15:41 PM
- Aeterna Zentaris and Ceapro Complete Merger Transaction • GlobeNewswire Inc. • 06/03/2024 01:15:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/31/2024 01:58:07 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:56:49 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:56:35 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:55:30 AM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 05/30/2024 01:31:16 AM
- Aeterna Zentaris Provides Update on Timing for Annual Meeting of Shareholders and Due Bill Redemption Date • GlobeNewswire Inc. • 05/29/2024 10:35:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/17/2024 12:00:34 PM
- Form FWP - Filing under Securities Act Rules 163/433 of free writing prospectuses • Edgar (US Regulatory) • 05/17/2024 12:00:32 PM
- Aeterna Zentaris Announces Details Regarding Transaction with Ceapro • GlobeNewswire Inc. • 05/17/2024 12:00:00 PM
- Aeterna Zentaris Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/14/2024 10:00:00 PM
- 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
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