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Why Heron Therapeutics Stock Is Tanking Today

By George Budwell – Updated Jun 29, 2020 at 11:29AM

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Its non-opioid painkiller gets a rejection over non-clinical issues.

What happened

Heron Therapeutics (HRTX 5.24%), a commercial-stage biopharma company, is having a tough go of it today. The company's shares were down by 28.6% as of 10:21 a.m. EDT on Monday. 

The culprit? Ahead of the opening bell, Heron announced that the Food and Drug Administration rejected its non-opioid painkiller HTX-011. Heron stated that the drug's regulatory filing was declined because of four non-clinical issues.

A man getting punched in the face.

Image source: Getty Images.

So what

HTX-011 is the company's most important value driver by a wide margin. If this closely watched pain medication ever gains marketing approval in both the U.S. and the EU, it should easily achieve annual sales in excess of $1 billion. That's an enormous revenue stream for a company that ended last week with a market cap of less than $2 billion. As such, it's not exactly surprising to see investors backing away from the stock after this latest regulatory setback. 

Now what

Per today's press release, Heron said that it plans to resubmit the drug's regulatory application as soon as possible. What this means is that the company could have HTX-011 back under consideration by the FDA within the next three months, and an approval in hand by year's end. That's not a surefire outcome by any means, but it is a real possibility.  

All told, this small-cap biotech arguably presents a rather intriguing risk-to-reward ratio in the wake of this double-digit pullback. Aggressive investors, in turn, might want to consider scooping up some shares soon.          

George Budwell has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Heron Therapeutics, Inc. Stock Quote
Heron Therapeutics, Inc.
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