Heron Therapeutics, Inc. HRTX announced that the European Commission (EC) has granted a marketing authorization to its investigational agent Zynrelef (formerly known as HTX-011) for the treatment of somatic postoperative pain in small-to-medium-sized surgical wounds among adult patients. The company is planning to launch the drug during 2021 in Europe.
The approval was expected as in July, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the marketing approval for Zynrelef to treat the above indication.
The approval in the EU was based on data from two multi-center, active and placebo-controlled phase III studies, which evaluated Zynrelef for addressing postoperative pain. Both studies met the primary endpoint as well as all key secondary endpoints. Data from the same showed that treatment with Zynrelef significantly reduced pain and opioid use through 72 hours compared to saline placebo and the bupivacaine solution, the current standard of care.
Shares of Heron were up 4.2% following the above announcement on Monday. However, the stock has declined 35.3% so far this year compared with the industry’s decrease of 8.5%.
Zynrelef is a non-opioid, dual-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
Notably, in June 2020, the FDA issued a complete response letter (CRL) to the NDA for HTX-011. The CRL was related to non-clinical issues. However, there were no clinical safety or efficacy issues or chemistry, manufacturing and control (CMC) issues. Following a successful Type A meeting with the FDA representatives in September 2020, Heron is now planning to resubmit the new drug application (NDA) for HTX-011 in the fourth quarter of 2020 for the management of postoperative pain.
We remind investors that the NDA for HTX-011 was previously issued another CRL in May 2019, in which the FDA had requested additional CMC and non-clinical information. Heron resubmitted the NDA last October. In February 2020, the regulatory body extended the review period for the HTX-011 NDA by three months. However, there was no reason mentioned for this extension. A potential approval in the United States will lend a significant boost to the company.
Zacks Rank & Stocks to Consider
Heron currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Aldeyra Therapeutics, Inc. ALDX, Ironwood Pharmaceuticals, Inc. IRWD and BioLineRx Ltd. BLRX, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aldeyra’s loss per share estimates have narrowed 16.4% for 2020 and 21.2% for 2021 over the past 60 days. The stock has rallied 23.4% year to date.
Ironwood’s earnings estimates have moved 27.5% north for 2020 and 22% for 2021 over the past 60 days.
BioLineRx’s loss per share estimates have narrowed 12.9% for 2020 and 26.9% for 2021 over the past 60 days.
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