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HRTX > Heron Stock Up 4.3% After Opioid Alternative Granted Priority Review Designation From FDA -- MarketWatch
8:52 am ET December 31, 2018 (MarketWatch)
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Shares of Heron Therapeutics (HRTX) rose 4.5% in premarket trade Monday after the company announced the U.S. Food and Drug Administration had accepted the new drug application for its non-opioid alternative for post-operative pain management, granting it priority review designation. The product, dubbed HTX-011, is a combination of a long-acting, extended-release form of local anesthetic bupivacaine and the anti-inflammatory medication meloxicam. "We believe that HTX-011 could have a considerable impact on the lives of patients by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery, especially at discharge," said Heron Chief Executive Barry D. Quart in a statement. The FDA had previously granted breakthrough therapy status for HTX-011 based on the results of Phase 2 studies and two completed Phase 3 studies. Those studies showed the drug produced significant reductions in pain intensity and need for opioids compared to a placebo and bupivacaine alone. Shares of Heron have gained 31% this year, while shares of the iShares NASDAQ Biotechnology ETF (IBB) have fallen 11%. The S&P 500 has fallen 7%.

-Sarah Toy

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December 31, 2018 08:52 ET (13:52 GMT)

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