Key Developments: AEterna Zentaris Inc (AEZS.PH)

AEZS.PH on Philadelphia Stock Exchange

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5 May 2015
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Latest Key Developments (Source: Significant Developments)

Aeterna Zentaris Inc announces plans to initiate Phase 3 study of Macrilen in AGHD following successful meeting with FDA
Monday, 13 Apr 2015 07:30am EDT 

Aeterna Zentaris Inc:Says plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate efficacy of Macrilen (macimorelin), novel orally-active ghrelin agonist.For use in evaluating adult growth hormone deficiency (AGHD), as well as dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarization.Says decision follows positive and helpful meeting with U.S. FDA regarding its New Drug Application for Macrilen.Company requested meeting to gain clarity on approval deficiencies described in Complete Response Letter (CRL) company received on Nov. 6, 2014.  Full Article

Aeterna Zentaris announces closing of $37 million public offering of common shares and warrants
Wednesday, 11 Mar 2015 10:15am EDT 

Aeterna Zentaris:Says closing of public offering of 59,677,420 units generating net proceeds of about $34.5 mln, with each unit consisting of one common share, 0.75 of Series A warrant to purchase one common share, and 0.50 of Series B warrant to purchase one common share, at purchase price of $0.62 per unit.Says the Series A warrants are exercisable immediately and expire five years following issuance at an exercise price of $0.81 per share.Says Series B warrants are exercisable immediately and expire 18 months following issuance at an exercise price of $0.81 per share.Says pre-funded Series C warrants are exercisable immediately and expire five years following issuance.Intends to use net proceeds from Offering to make the $5.7 mln payment to the holders of warrants in connection with warrant amendment agreements described above, to continue to fund ongoing drug development activities.Also uses for the potential addition of commercialized products to the Company's pipeline, and for general corporate purposes, for working capital and to fund negative cash flow.  Full Article

Aeterna Zentaris announces pricing of $37 million public offering of common shares and warrants
Friday, 6 Mar 2015 08:30am EST 

Aeterna Zentaris Inc:Pricing of its previously announced public offering 59,677,420 units.Each Unit consists of one common share, 0.75 of a Series A warrant to purchase one common share, and 0.50 of a Series B warrant to purchase one common share, at purchase price of US$0.62 per Unit.Offering is expected to close on or about March 11.Net proceeds from the Offering are expected to be about $34.5 million, after deducting underwriting commissions and other expenses related to the Offering.Company intends to use the net proceeds from the Offering to make the $5.7 million payment to the holders of warrants in connection with the warrant amendment agreements described above.To continue to fund ongoing drug development activities, for the potential addition of commercialized products to the Company's pipeline, and for general corporate purposes, for working capital and to fund negative cash flow.Canaccord Genuity Inc. is acting as the sole book-running manager for the Offering. Maxim Group LLC, H.C. Wainwright & Co., LLC and Roth Capital Partners acted as co-managers for the Offering.  Full Article

Aeterna Zentaris Inc announces proposed public offering of common shares and warrants
Thursday, 5 Mar 2015 04:08pm EST 

Aeterna Zentaris Inc:Has commenced an underwritten public offering of units.Units will consist of common shares, Series A warrants to purchase common shares and Series B warrants to purchase common shares.Canaccord Genuity Inc. is acting as sole manager for proposed offering.Proposed offering is subject to customary conditions, including approval of The NASDAQ Stock Market (NASDAQ) and Toronto Stock Exchange (TSX), and there can be no assurance as to whether or when the proposed offering may be completed, or as to actual size or terms of offering.Company has no intention of listing either series of warrants on NASDAQ or TSX.  Full Article

Ergomed plc announces co-development partner news from Aeterna Zentaris
Monday, 8 Dec 2014 02:00am EST 

Ergomed plc:Says that Aeterna Zentaris has signed an exclusive licence and technology transfer agreement with Sinopharm A-Think.For Chinese, Hong Kong and Macau markets for zoptarelin doxorubicin which is in Phase 3 development for treating endometrial cancer.Says Sinopharm A-Think will be responsible for development, production, registration and commercialization of product in these markets.Sinopharm A-Think will be responsible for development, production, registration and commercialization of product in these markets.  Full Article

Aeterna Zentaris and Sinopharm A-Think sign master collaboration agreement for Zoptarelin Doxorubicin in China
Monday, 1 Dec 2014 07:30am EST 

Aeterna Zentaris Inc and Sinopharm A-Think Pharmaceuticals Co., Ltd:Signs license and technology transfer agreement, for the lead anti-cancer compound, zoptarelin doxorubicin, for the initial indication of endometrial cancer, for the Chinese, Hong Kong and Macau markets.Under the terms of the Master Collaboration Agreement, Aeterna Zentaris will be entitled to receive a non?refundable $1 million fee for the transfer of the Company's technology for zoptarelin doxorubicin to SinopharmA-Think.  Full Article

Kantrowitz, Goldhamer & Graifman, P.C. files fraud class action against Aeterna Zentaris
Monday, 17 Nov 2014 04:45pm EST 

Kantrowitz, Goldhamer & Graifman, P.C:Files a securities fraud class action against Aeterna Zentaris Inc and certain of its senior executives in the United States District Court for the District of New Jersey.Says FDA had issued a Complete Response Letter refusing to approve the New Drug Application referencing "the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD.Case alleges materially false or misleading statements made by defendants with respect to the safety and efficacy of the drug Macrilen.Lawsuit is brought on behalf of a class of investors who purchased shares of Aeterna Zentaris between and including June 26, 2012 and Nov. 5.  Full Article

FDA issues complete response letter for Aeterna Zentaris Inc's Macrilen NDA in Adult Growth Hormone Deficiency
Thursday, 6 Nov 2014 07:00am EST 

Aeterna Zentaris Inc:Has received complete response letter (CRL) from U.S. Food and Drug Administration.For its New Drug Application (NDA) for MacrilenTM(macimorelin), novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency.Based on its review, FDA has determined that NDA cannot be approved in its present form.CRL mentions that planned analysis of company's pivotal trial did not meet its stated primary efficacy objective as agreed to in special protocol assessment agreement letter between company and FDA.CRL further mentioned issues related to the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD.CRL also outlined that a serious event of electrocardiogram QT interval prolongation occurred for which attribution to drug could not be excluded.  Full Article

Aeterna Zentaris and ASCEND Therapeutics sign co-promotion agreement for U.S. Market
Tuesday, 5 Aug 2014 07:30am EDT 

Aeterna Zentaris Inc:Signs a strategic co-promotion services agreement with ASCEND Therapeutics.Expects to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific U.S. territories, ASCEND's EstroGel a non-patch transdermal U.S. Food & Drug Administration (FDA) approved and commercialized estrogen replacement therapy.  Full Article

Aeterna Zentaris Inc appointed Chairman
Monday, 12 May 2014 07:30am EDT 

Aeterna Zentaris Inc:Appointed current President and CEO, David Dodd, as Chairman of Board.Board believes that with both roles being assumed by David Dodd.Former Chairman of Board and an independent director, will assume role of Lead Director.  Full Article

Aeterna hits record low after FDA rejects growth hormone test

- Canada's Aeterna Zentaris Inc said the U.S. Food and Drug Administration rejected macimorelin, which the drugmaker had hoped would be the first orally administered drug to determine if adults had growth hormone deficiency.

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