Auris Medical Holding AG (NASDAQ:EARS) was one of the big market movers on Tuesday in the biotechnology space. The company announced during the session that data from one of its lead investigations had failed to hit the mark and that, as a result, it was terminating an associated program.
The news hit Auris pretty hard and the company closed out the session on Tuesday to close at a 50% discount to its price just one day earlier.
So what happened?
For those unfamiliar with Auris, the company is a biotechnology stock that is trying to develop a range of treatments targeting various ear and hearing related conditions. The company is headquartered in Switzerland and, prior to yesterday’s news, had had a pretty solid few weeks – running from around $0.60 a share back on November 9 to just shy of one dollar a share at the end of last week.
With the latest news in hand, however, this good fortune has turned around.
Before getting into the details, it is worth noting that, earlier this year, another of Auris’ lead development assets, a drug that was under investigation as a potential therapy for tinnitus, also failed to meet its primary endpoints in a late-stage investigation.
Subsequent to the completion of this investigation, the company reported that by way of a post hoc analysis it was able to squeeze out some positive data from a subset of patients and that this – to a degree – warranted a continuation of the study. Markets frown on this sort of analysis but it seemed – at the time – that many participants were willing to give Auris the benefit of the doubt.
Anyway, that’s in the past.
The most recent study was investigating a drug called AM-111 in patients with severe to profound sudden deafness. The investigation was set up to look at two separate doses of the drug, one high, one low, and to assess whether either dose can have any impact on the severity of the profound sudden deafness in the patients in question, with this impact measured against a placebo arm in the study.
And as it turns out, it doesn’t look like it can.
The drug failed to improve against placebo in this indication in both the high and the low dose arms of the study across the aggregate population and, as a result, the trial is deemed a failure.
But wait a second – yet again, the company is suggesting that a post hoc analysis could serve to shed a positive light on the overarching outcome of the result. Specifically, and as was reported by management yesterday, in a small high severity subsector of patients, the low dose formulation of the asset seems to induce a response that is statistically significant as compares to placebo.
For some, this might be a little bit of a reprieve. For wider markets, however, it’s nowhere near enough to turn sentiment to positive.
As noted, on the back of the development, the company is down close to 50% and there is a strong chance we’re going to see a continuation of this downside momentum as Auris matures towards the close of 2017.
Another mover on Tuesday was Viking Therapeutics (NASDAQ:VKTX) and, in this instance, the move is a positive one. After the session drew to a close, the company announced that one of its studies, a phase 2 clinical trial assessing a drug called VK5211 in patients with recent hip fractures, met its primary endpoint of a statistically significant increase in lean body mass, less head compared to placebo.
As yet, and likely due to the after-hours nature of the report, markets are yet to respond to the news to any substantial degree. The company closed out the session trading for in and around $2.82 and premarket activity has brought this to $2.88 – a circa 3% increase – but, there is a good chance we will see some continued strength as the bell rings on Wednesday and active participation ensues.
Exactly how far the company can run on the news remains to be seen (market cap sits at around $80 million, so there’s plenty of room for upside) and we’ll revisit the stock tomorrow to take a look at what happened.