Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain

Heron received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 30, 2019.¹ A CRL is sent to drug manufacturers to indicate that the review cycle for an application is complete and that the application is not ready for approval.² “The FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.” However, the FDA is requiring further chemistry manufacturing and controls (CMC) and non-clinical information. The company’s CEO plans to meet with the FDA and resubmit an NDA.¹

As I write this post at around 9AM CT, a share of HRTX is approximately $18. At this point, I will be removing HRTX from my watch list. From my technical analysis, it does not appear that a reversal will be coming anytime soon. I have set an alert for $20 on this ticker just to follow up with the manufacturer in the future. HTX-011 showed promise in their clinical trials and I believe the product will help reduce post-operative opiate use once it’s approved and available on the market.

REFERENCES

1. Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain.; (2019). Available at https://herontherapeutics.gcs-web.com/news-releases/news-release-details/heron-therapeutics-receives-complete-response-letter-htx-011
2. U.S. Food and Drug Administration (FDA) . Complete Response Letter Final Rule. http://www.fda.gov/drugs/laws-acts-and-rules/complete-response-letter-final-rule. May, 01 2019