Update: Heron Therapeutics stock down 31% after FDA says it can't approve pain drug without more info

Shares of Heron Therapeutics Inc. fell 31% on Wednesday after the biotech said the FDA would not 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. Shares of Heron have fallen 16.4% so far this year, while the S&P 500 has gained 17.5%.

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