Key Developments: AEterna Zentaris Inc (AEZS.PH)

AEZS.PH on Philadelphia Stock Exchange

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16 Dec 2014
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Latest Key Developments (Source: Significant Developments)

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 Zentaris Inc. closes US$13.2 mln public offering of common shares and warrants
Tuesday, 14 Jan 2014 11:15am EST 

Aeterna Zentaris Inc:Says the closing of its previously announced public offering of 11.0 mln units.Says it generated net proceeds of about US$12.2 mln.Says each unit consisting of one common share and 0.8 of a warrant to purchase one common share, at a purchase price of US$1.20 per unit.Says Each warrant is exercisable for a period of five years at an exercise price of US$1.25 per share.Says Canaccord Genuity Inc. acted as the sole book-running manager, and Maxim Group LLC, H. C. Wainwright & Co., LLC and MLV & Co LLC acted as co-managers for the Offering.Says the company intends to use the net proceeds for future negative cash flow, general corporate purposes and working capital.  Full Article

Aeterna Zentaris Inc. announces pricing of US$13.2 mln public offering of common shares and warrants
Thursday, 9 Jan 2014 08:31am EST 

Aeterna Zentaris Inc:Says the pricing of its previously announced public offering of 11.0 mln units, with each unit consisting of one common share and 0.8 of a warrant to purchase one common share, at a purchase price of US$1.20per unit.Says each warrant will be exercisable for a period of five years following the issuance thereof at an exercise price of US$1.25 per share.Says the net proceeds from the Offering are expected to be about US$12.2 mln.Says Canaccord Genuity Inc. is acting as the sole book-running manager for the Offering. Maxim Group LLC, MLV & Co LLC and H. C. Wainwright & Co., LLC acted as co-managers for the Offering.Says the Offering is expected to close on or about Jan. 14.  Full Article

Aeterna Zentaris Inc. announces proposed public offering of common shares and warrants
Wednesday, 8 Jan 2014 04:05pm EST 

Aeterna Zentaris Inc:Says it has commenced an underwritten public offering of units, consisting of common shares and warrants to purchase common shares.Says the pricing and number of Units as well as the exercise price and duration of the warrants will be determined in the course of marketing.Says Canaccord Genuity is acting as sole book-running manager for the proposed Offering.  Full Article

Aeterna Zentaris Inc NDA for Macimorelin Acetate in AGHD accepted for filing by the FDA
Monday, 6 Jan 2014 12:00pm EST 

Aeterna Zentaris Inc:Says the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency (AGHD).Says the acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.  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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