AEterna Zentaris Inc. (AEZS)

[chmcnfunds]

Aeterna Zentaris doubles down on macimorelin PhIII, and loses

by john carroll

January 4, 2017 06:21 PM EST
Updated: January 5, 2017 07:51 AM

Aeterna Zen­taris CEO David Dodd
Two years after the FDA handed Aeterna Zen­taris a sting­ing re­jec­tion for its pro­posal to mar­ket maci­more­lin for the eval­u­a­tion of growth hor­mone de­fi­ciency in adults, the biotech says the drug flunked an­other late-stage study.

Just as Aeterna Zen­taris wit­nessed in late 2014, its stock $AEZS cratered, drop­ping by about 50% in after-mar­ket trad­ing.

The FDA sent Aeterna Zen­taris back to the clin­i­cal draw­ing board after point­ing out that maci­more­lin had failed to hit the pri­mary end­point. Aeterna Zen­taris moved from Canada down to Charleston, SC more than two years ago, promis­ing to cre­ate 60 jobs.

There’s no im­me­di­ate word on next-steps at the biotech for this two-time fail­ure, but CEO David Dodd has a backup plan. In a state­ment, he said:

While we are dis­ap­pointed re­gard­ing the out­come of this trial, we will now re-di­rect our re­sources to the com­ple­tion of the on-going Phase 3 clin­i­cal trial of Zop­trex in women with ad­vanced, re­cur­rent or metasta­tic en­dome­trial can­cer who have pro­gressed and who have re­ceived one chemother­a­peu­tic reg­i­men with plat­inum and tax­ane (ei­ther as ad­ju­vant or first-line treat­ment).
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https://endpts.com/aeterna-zentaris-doubles-down-on-macimorelin-phiii-and-loses/

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