AcelRX Selling Off Sharply On FDA Reexamination
Shares of AcelRx Pharmaceuticals (NASDAQ: ACRX) are selling off sharply monday morning after a blow from the FDA to Zalviso.
AcelRx made the announcement at an unusual time: 9:59 p.m. ET Friday.
The FDA is looking for more information on how to use Zalviso, bench data to show a reduction in optical errors and information on the reported shelf life, as stated in a complete response letter.
AcelRx disclosed that additional bench testing will be required to move forward and human factors testing may be required.
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The silver lining is that amendments to the new drug application have been filed, but not yet reviewed by the FDA. This information may satisfy some FDA requests.
CEO Richard King stated, “We are confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."
Shares of AcelRX were last trading 34.4 percent lower at $7.10.
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