FDA won’t approve Heron Therapeutics’ HTX-011, says it needs more info
Heron Therapeutics Inc. said on Wednesday that the FDA would not be able to approve the new drug application for its pain-management drug HTX-011 in its present form. The regulatory agency did not identify any clinical or safety issues with the drug, but wrote in a complete response letter that it was unable to approve the application due to a need for more non-clinical data and additional information on chemistry, manufacturing and controls, Heron said.
“We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible,” said Chief Executive Barry Quart.
The stock was halted for the news.
Shares of Heron have fallen 16.4% so far this year, while the S&P 500 has gained 17.5%.
Source : MTV
