Key Developments: AEterna Zentaris Inc (AEZS.W)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
AEterna Zentaris Inc Announces Transfer Of Manufacturing Rights Related To Cetrotide To Merck KGaA
AEterna Zentaris Inc announced that its German subsidiary has entered into binding agreements with various partners and licensees with respect to the manufacturing rights and obligations for its Cetrotide product. The principal effect of such agreements is to transfer manufacturing rights and to grant a manufacturing license for Cetrotide to a subsidiary of Merck KGaA of Darmstadt, Germany (Merck Serono), in all jurisdictions. Subject to the satisfaction of customary closing conditions, the transaction is expected to be completed on or about October 1, 2013, at which time Aeterna Zentaris would receive a one-time payment of EUR2.5 million, or approximately $3.2 million and certain other payments. In addition, the Company has also entered into a transitional services agreement with Merck KGaA under which the Company will, during a 36-month period, provide various transition services to assist Merck KGaA in assuming responsibility for the manufacturing of Cetrotide in consideration for the payment of a monthly fee to the Company throughout such period. Full Article
AEterna Zentaris Inc Announces Appointment Of New President and Chief Executive Officer
AEterna Zentaris Inc announced that David A. Dodd has been appointed President and Chief Executive Officer of the Company, succeeding Juergen Engel, PhD. Mr. Dodd has also been appointed director on the Company's Board of Directors. Aeterna Zentaris Inc. is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. Full Article
AEterna Zentaris Inc Announces Final Phase 2 Data Demonstrate Perifosine and Sorafenib Combination Theraphy Result
AEterna Zentaris Inc announced that final Phase 2 data demonstrated that the combination of perifosine, its oral AKT inhibitor, and sorafenib, was well tolerated by heavily pretreated patients with relapsed/refractory lymphomas. Furthermore, promising clinical response activity was observed in patients with classical Hodgkin Lymphoma ("HL"), suggesting that this subgroup could represent the target population for future studies. Data were presented by Anna Guidetti, MD, of the Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy, during a poster session at the American Society of Hematology annual meeting in Atlanta, Georgia. Based on tumor response to the initial 4 week perifosine therapy, 36 of 40 patients who achieved less than PR were subsequently administered the perifosine/sorafenib combination therapy. Median duration of combination therapy was 4 months (range: 2-18). Four CLL patients who achieved at least a PR with perifosine alone, went off-study and continued with single-agent therapy with a median duration of response of 10 months (range 4-21). The most common drug-related toxicities were grade 1-2 diarrhea (25%), joint pain (22%), weight loss (19%), anemia (17%), and thrombocytopenia (9%). Hand-foot skin reaction was observed in 25% (grade 2) and 14% (grade 3) of patients. Grade 4 neutropenia was observed in only 1 patient. Two responding patients experiencing grade 3 pneumonitis discontinued treatment. Full Article
AEterna Zentaris Inc Announces Closing Of $16.5 Million Public Offering Of Common Shares And Warrants
AEterna Zentaris Inc announced the closing of its previously announced public offering of 6.6 million units (the Offering) generating net proceeds of $15.2 million, with each unit consisting of one common share and 0.45 of a warrant to purchase one common share, at a purchase price of $2.50 per unit. Each warrant is exercisable for a period of five years at an exercise price of $3.45 per share. Roth Capital Partners, LLC, acted as the sole managerfor the Offering. The Company intends to use the net proceeds from the Offering to continue to fund its ongoing drug development activities, particularly for the continued development of perifosine in multiple myeloma and the advancement of its AEZS-108 and AEZS-130 programs, as well as for general corporate purposes and working capital. Full Article
AEterna Zentaris Inc Announces Pricing of $16.5 Million Public Offering Of Common Shares And Warrants
AEterna Zentaris Inc announced that the pricing of its previously announced public offering of 6.6 million units (the Offering), with each unit consisting of one common share and 0.45 of a warrant to purchase one common share, at a purchase price of $2.50 per unit. Each warrant will be exercisable for a period of five years following the issuance thereof at an exercise price of $3.45 per share. Net proceeds from the Offering are expected to be approximately $15.2 million, after deducting underwriting commissions and other expenses related to the Offering. Roth Capital Partners, LLC is acting as the sole manager for the Offering. The Offering is expected to close on or about October 17, 2012, subject to customary closing conditions including, but not limited to, the receipt of all necessary regulatory approvals, including the approvals of the Toronto Stock Exchange and the NASDAQ Global Market. Full Article
AEterna Zentaris Inc Announces Proposed Public Offering of Common Shares and Warrants
AEterna Zentaris Inc announced that it has commenced an underwritten public offering of units (the Offering), consisting of common shares and warrants to purchase common shares. Roth Capital Partners, LLC, is acting as the sole book-running manager for the Offering. The Offering is subject to market conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. Full Article
AEterna Zentaris Inc Granted Patent In U.S. For AEZS-130 As Diagnostic Test For Adult Growth Hormone Deficiency
AEterna Zentaris Inc announced that the United States Patent and Trademark Office has granted a patent for the use of its oral ghrelin agonist, AEZS-130 (EP1572) as a diagnostic test for adult growth hormone deficiency (AGHD). Filed on February 19, 2007, the patent (US 8,192,719 B2) titled, "Methods and Kits to Diagnose Growth Hormone Deficiency by Oral Administration of EP1572 or EP1573 Compounds", became effective as of June 5, 2012, and will expire on October 12, 2027. The corresponding composition of matter patent (US 6,861,409 B2), filed on June 13, 2001 and granted on March 1, 2005, will expire on August 1, 2022, with the possibility of a patent term extension of up to five years. Full Article
Faruqi & Faruqi, LLP Notifies Investors Who Suffered Substantial Losses Investing In AEterna Zentaris Inc. Of Upcoming August 14, 2012 Lead Plaintiff Deadline
Faruqi & Faruqi, LLP, announced that it is investigating potential securities fraud at AEterna Zentaris Inc. The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose in a timely manner that AEterna's drug perifosine was not effective in treating colorectal cancer. On April 2, 2012, AEterna announced that the Phase 3 X-PECT (Xeloda and Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine and capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine and placebo. As a result of this news, the Company's stock plummeted $1.41 per share to close at $0.73 per share on April 2, 2012, a one-day decline of approximately 66% on high volume. Full Article
AEterna Zentaris Inc Announces Preclinical Data For Aezs-108 In Bladder Cancer Published Online In Oncotarget
AEterna Zentaris Inc announced that preclinical data for the Company's targeted cytotoxic luteinizing hormone-releasing hormone (LH-RH) analog, AEZS-108 (formerly AN-152), in urinary bladder cancer, have been published in the online edition of Oncotarget. The article outlines AEZS-108's powerful growth inhibition of bladder cancers in nude mice, as well as its safety profile. The study investigated the expression of LH-RH receptors in clinical bladder cancers and in HT-1376, J82, RT-4 and HT-1197 human bladder cancer lines. The effect of AEZS-108 on growth of these tumor lines xenografted into nude mice was analyzed. Molecular and functional assays were used to also evaluate differences between the effects of AEZS-108 and doxorubicin (DOX), the cytotoxic moiety of AEZS-108, alone. The study demonstrated the expression of LH-RH receptors on 18 clinical bladder cancers by immunohistochemistry and on four human urinary bladder cancer lines HT-1376, J82, RT-4 and HT-1197 by Western blotting and binding assays. AEZS-108 powerfully inhibited growth of these bladder cancers in nude mice, exerted greater effects than DOX and was less toxic. In contrast to DOX alone which activated strong multidrug resistance mechanisms in RT-4 and HT-1197 cancers, AEZS-108 had no or less such effects. PCR assays and in vitro studies revealed differences in the action of AEZS-108 and DOX on the expression of genes involved in apoptosis. Full Article
Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing In AEterna Zentaris Inc. To Contact Firm
Faruqi & Faruqi, LLP, a national securities law firm, announced that it has filed a class action lawsuit in the United States District Court for the Southern District of New York, Case No. 12-Civ-4711, on behalf of all persons who purchased AEterna Zentaris Inc. securities between February 3, 2010 and April 1, 2012 inclusive (the Class Period). AEterna, AEterna's Chief Executive Officer Juergen Engel and AEterna's Chief Financial Officer Dennis Turpin are charged with violations of Section 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Specifically, Plaintiff's complaint alleges that defendants misled investors about the timing and success of AEterna's clinical trial that tested whether the drug perifosine was effective in treating late stage colorectal cancer. On April 2, 2012, AEterna shocked the market by disclosing that perifosine was ineffective in treating colorectal cancer. This news caused AEterna stock to drop approximately 66% by the close of the business day. Plaintiff now seeks to recover damages on behalf of himself and all other individual and institutional investors who bought AEterna securities between February 3, 2010 and April 1, 2012, excluding defendants and their affiliates. Plaintiff is represented by Faruqi & Faruqi, LLP. Full Article
Aeterna Zentaris to stop late-stage cancer drug trial, shares fall
- Canadian drugmaker Aeterna Zentaris Inc said it would discontinue a late-stage trial of a cancer drug after an independent data safety monitoring committee said the drug was unlikely to help increase patient survival.
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