Heron Therapeutics Resubmits NDA for HTX-011

Shares of US biotech firm Heron Therapeutics (Nasdaq: HRTX) were up 4.16% at $19.27, after it revealed that it has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a six-month review by the FDA.

Stifel analyst Derek Archilia reiterated a Buy rating on Heron Therapeutics following the announcement today.

The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in April 2019. The CRL stated that the FDA was unable to approve the NDA in its present form based on the need for additional chemistry, manufacturing and controls and non-clinical information.
"We are pleased to have reached agreement with the FDA on the required information to include in the HTX-011 NDA resubmission to address the CRL," said Barry Quart, president and chief executive of Heron.

"HTX-011 was designated by the FDA as a Breakthrough Therapy for postoperative pain management and has the potential to be an important new pain management option for patients that can significantly reduce postoperative pain, including severe pain, and help patients significantly reduce the need for opioids," he noted.