Otonomy Just Did Something That's Almost Never Seen In Biotech

A number of companies had a great week this week in the biotechnology space, including Dynavax Technologies Corporation (DVAX), which finally picked up regulatory approval in the US for Heplisav B, its low dose requirement hepatitis B vaccine, and OncoSec Medical Inc (ONCS), which was able to show that its development stage ImmunoPulse IL-12 asset is effective when used as a combination therapy alongside Keytruda in patients with melanoma.

One that stands out from the crowd, however, is Otonomy Inc (OTIC).

This is a small-cap biotechnology company that has had an incredibly rough twelve months and that – at the end of August – fell from more than $20 a share to just $3.50 on the back of an update as to the progress of its then-lead development asset along its pathway to commercialization in the US.

This week, however, the company has staged something of a turnaround, currently trading for just shy of $5, up close to 60% on its price at the bell on Monday.

There's still plenty of gap between the pre-crash pricing and today's market capitalization, but the driver behind the recent run suggests that this gap may start to close over the coming months. Importantly, there are a few key developments to keep an eye on between now and the start of the first quarter of next year that, if they play out favorably, will suggest a longer-term return to the $20 mark and, potentially, higher, isn’t too much of a stretch.

Here's what happened and what to watch going forward as supportive of a return to $20.

All told, this one is a bit of a strange situation in the biotech space.

Otonomy's lead development asset is a drug called Otividex. It's a steroid type asset that's designed to be injected into the inner ear as a treatment for what's called Ménière’s disease, which is a debilitating form of vertigo that also causes tinnitus and hearing loss.

Back in August, the company announced that a phase III trial set up to investigate the safety and efficacy of this asset in patients suffering from Ménière’s disease had failed to meet its primary and secondary endpoints and that – as a result – the company would move to "immediately suspend all development activities for (the drug) including the ongoing AVERTS-2 trial."

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Disclosure: the author has no positions in any of the stocks mentioned in this piece. 

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Moon Kil Woong 2 years ago Contributor's comment

This pathway is far from certain and i would not like to be the one betting on it. That is why such pushes are not often done for FDA approval. It seems more based on no other choice than anything else.