Search This Blog

Monday, June 29, 2020

FDA rejects Heron Therapeutics’ NDA for HTX-011 for postoperative pain

Heron Therapeutics (NASDAQ:HRTX) is down 11% premarkket in reaction to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its NDA for HTX-011 for the management of postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information.
The Agency did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.
The Company will request a Type A meeting to obtain agreement with the Agency and resubmit the application as quickly as possible.


No comments:

Post a Comment

Note: Only a member of this blog may post a comment.