Tenax Therapeutics Inc (NASDAQ:TENX)
After the market close last Friday, Tenax Therapeutics Inc (NASDAQ:TENX) provided a regulatory update after consultations with the U.S. Food and Drug Administration (FDA) and Health Canada regarding a regulatory path forward for their drug candidate levosimendan. The market has reacted negatively today, sending the shares down over 25% by noon EST on volume over seven times their listed 30-day average.
Last May, Tenax Therapeutics Inc (NASDAQ:TENX) held discussions with the FDA on a New Drug Application (NDA) for levosimendan in two indications – artery bypass grafting and acute decompensated heart failure. According to Tenax’s press release, the FDA has reviewed existing analyses and decided to request additional clinical trials.
The expense associated with such trials is enormous and Tenax Therapeutics Inc (NASDAQ:TENX) has decided to consult with their financial advisors before deciding on a path forward. The additional clinical trials would necessarily lower any ROI associated with the commercialization associated with the drug candidates if it was approved for sale by the FDA – a decision that is not guaranteed by any stretch. Accordingly, the company will also be considering strategic alternatives with Ladenburg Thalmann & Co. that will likely include a sale, merger, or strategic investment amongst other possibilities – none of which bode well for current shareholders.
Adjusted for dilution, shares of Tenax Therapeutics Inc (NASDAQ:TENX) had traded above $160 per share back in 2009 before going into a long decline that has not seen the shares trade above $1 since February. YTD, TENX shares are down over 60%, and are down over 70% for the year. In 2012, shareholders experienced a per share loss of (-$6.29) but that loss narrowed each successive year until 2016. In 2016 the per share loss was posted at (-$1.56) – an increase over 2015’s per share loss of (-$036). According to the NASDAQ>com website, there is only one firm that follows TENX shares and they give them a “Strong Buy” rating. The name of the lone firm? Ladenburg Thalmann & Co.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.