Plus   Neg

Heron Gets CRL For HTX-011 For Management Of Postoperative Pain; Stock Down

Heron Therapeutics Inc. (HRTX) said that it received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its New Drug Application for HTX-011 for the management of postoperative pain.

In Monday pre-market trade, HRTX is trading at $17.55, down $2.27 or 11.45 percent.

The Complete Response Letter has requested additional non-clinical information. The FDA did not identify any clinical safety or efficacy issues or CMC issues, the company said in a statement.

There are four non-clinical issues in the CRL, none of which relate to any observed toxicity, the company said. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.

The company noted that it will request a Type A meeting to obtain agreement with the Agency on its responses and resubmit the application as quickly as possible.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
General Electric Co. filed a lawsuit against Siemens Energy AG, accusing the German power distribution company of stealing trade secrets for gas turbines. Siemens Energy allegedly used the information to get at least nine contracts to supply gas turbines to public utilities, and also covered up improper business gains. Following a court ruling, the U.S. Food and Drug Administration postponed the effective date for tobacco manufacturing companies to display new health warnings on cigarette packets and in advertisements, by additional 90 days. The warnings with color images is to promote greater public understanding of the negative health consequences of smoking. JPMorgan Chase & Co (JPM) reported strong results in the fourth quarter of 2020, with net profit up 42% largely driven by credit reserve releases of $2.9 billion. The Group said it ended the year with a CET1 ratio of 13.1% and capital above $200 billion, providing with meaningful capacity to further...
Follow RTT