Stock Update (NASDAQ:AEZS): AEterna Zentaris Inc. (USA) Announces Completion of Zoptrex Pivotal Phase 3 Clinical Trial in Advanced Endometrial Cancer


AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced the occurrence of the 384th death in the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with Zoptrex™ (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, representing the clinical endpoint of the study. The Company currently expects to lock the clinical database and to report top-line results in April 2017. Zoptrex™ is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the United States Food and Drug Administration (the “FDA”).

Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are pleased to announce the completion of the clinical phase of our pivotal Phase 3 clinical study of Zoptrex™, which was conducted under a Special Protocol Assessment with the FDA. Reaching this important milestone took longer than we anticipated because the rate of events slowed significantly during the past year. As previously reported, the study was fully enrolled in June 2015 and the final dosing occurred in January 2016. Therefore, a significant number of patients survived more than 18 months since enrollment in the study. We are thankful that these patients continued to survive a devastating disease and are hopeful that their lives are continuing successfully. We are close to locking the clinical database and are focused on producing the top-line results of the study. Currently, we expect to release top-line results in April 2017.”

David A. Dodd, President and Chief Executive Officer of the Company stated, “With the completion of the clinical portion of this trial, we will now focus on analyzing the data and, if warranted by the results, submitting a new drug application later this year. There is a significant unmet medical need for a treatment for women with advanced, recurrent or metastatic endometrial cancer and we are hopeful that Zoptrex™ will provide clinicians and their patients with an effective therapy for treating the disease. We are indebted to all 512 patients who participated in this important clinical program and, hopefully, we will advance to providing a very important new therapy for this devastating cancer.”

Shares of Aeterna Zentaris closed today at $2.60, up $0.05 or 1.96%. AEZS has a 1-year high of $5.59 and a 1-year low of $2.35. The stock’s 50-day moving average is $3.21 and its 200-day moving average is $3.51.

On the ratings front, AEZS has been the subject of a number of recent research reports. In a report issued on January 6, Maxim analyst Jason Kolbert maintained a Buy rating on AEZS, with a price target of $7, which represents a potential upside of 169% from where the stock is currently trading. On the same day, Canaccord’s Neil Maruoka reiterated a Buy rating on the stock and has a price target of $5.50.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Neil Maruoka have a yearly average loss of -16.8% and -14.8% respectively. Kolbert has a success rate of 27% and is ranked #4317 out of 4378 analysts, while Maruoka has a success rate of 29% and is ranked #4288.

Æterna Zentaris, Inc. operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health.

 

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