Aeterna Zentaris (TSX: AEZ,Stock Forum) was still feeling the sting over yesterday's announcement that the US FDA had rejected its NDA on the Macrilen, an oral diagnostic test for adult growth hormone deficiency (AGHD).
The FDA's Complete Response Letter cited that the Phase III trials failed to meet the stated primary efficacy objective as outline in a Special Protocol Assessment agreement letter between the company and the FDA. The agency also went on to state that there were issues regarding the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD.
Further hurdles were thrown into the mix when the FDA demanded the company launch a new, confirmatory clinical study to address the aforementioned issues.
Investors weren't impressed as management had assured them all requirements were met in the Phase II trials and as a result, shares dumped ~49% by the end of the day.
According to today's news release, Rosen Law Firm announced that it was launching an investigation into Aeterna's actions regarding Macrilen's NDA on behalf of investors and asked shareholders who purchased company stock between October 18, 2012 and November 6, 2014 to visit their website to join the class action or obtain more information.
While some investors took their loss and ran for the hills, others decided to hold on despite the increased risk and loss of credibility citing the company seemed to have an endless financing supply to carry it through to eventual commercialization.
Shares slipped 16.22% on the news to $0.62 per share.
Currently there are 63.9m outstanding shares with a market cap of $42.2 million.