Heron Therapeutics news concerning the company’s HTX-011 pain drug has HRTX stock falling hard on Wednesday.
Heron Therapeutics (NASDAQ:HRTX) says that it has received the U.S. Food and Drug Administration’s (FDA) official response to its New Drug Application for HTX-001. Unfortunately for HRTX stock, the FDA has rejected the drug.
According to a Heron Therapeutics news release, the FDA rejection requires the company to present additional chemistry manufacturing and controls, as well as more non-clinical information. HRTX says that it is requesting a meeting with the FDA to discuss resolving the issue.
The Heron Therapeutics news notes that the company doesn’t need any further clinical studies or data analyses of HTX-011. It also says that the FDA doesn’t outline any clinical safety or efficacy issues with the drug in its rejection letter.
Heron Therapeutics says that it is planning to resubmit its New Drug Application for HTX-011. It will do this as soon as it has found out what additional information the FDA wants from the company. The company doesn’t provide a time frame for when this will occur.
HTX-011 is Heron Therapeutics’s pain drug for treating “investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.”
HRTX stock was down 13% as of Wednesday morning and is down 16% since the start of the year.
As of this writing, William White did not hold a position in any of the aforementioned securities.