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Heron Therapeutics Inc (NASDAQ:HRTX) was in for a disappointment after the FDA knocked down its new drug application for its investigational compound for post-operative pain management.
What Happened
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The biotech announced Wednesday the FDA issued a complete response letter, or CRL, for its lead candidate HTX-011, which is being evaluated for managing postoperative pain.
The regulatory agency said in the CRL the NDA cann't be approved in the current form and that additional chemical, manufacturing and control and non-clinical information is needed.
The FDA didn't identify any clinical safety or efficacy issues, however, stating no further clinical studies or data analyses are needed.
HTX-011 is a long-acting, extended-release formulation of local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
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HTX-011 is the only candidate Heron has in its clinical development pipeline, while another HTX-034 is in preclinical development. The NDA was accepted for priority review and the candidate has Breakthrough Therapy designation.
Heron had filed for EU Marketing Authorization Approval by centralized procedure in the first half of 2019.
What's Next
Heron said it plans a meeting with the FDA to agree with it on an approach to resolve the identified issues and resubmit the NDA as soon as possible.
In pre-market trading, Heron shares traded down 22.5 percent to $16.59.
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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.