AcelRx Pharma Meets Expectations, But Says It Won't Submit New Zalviso Application
AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) extended its losses in after-hours trading Monday after the company said it won't submit a new drug application in the current quarter for its lead drug candidate, pain medication Zalviso.
AcelRx changed hands recently at $5.45, off $0.06 in the extended session, after closing down 37 percent on Monday.
The company posted fourth quarter results that met expectations after the bell, but told investors earlier on Monday that regulators seek an additional clinical study to assess the risk of dispensing failures for Zalviso.
AcelRx swung to a fourth quarter loss of $13.8 million, or $0.32 a share, from year-earlier net income of $17.8 million, or $0.39 a share.
Year-earlier results included a $30 million upfront payment under a collaborative drug development agreement with Grunenthal.
Expenses in the recent period rose sharply in support of potential commercialization of Zalviso, as well as for the submission of Zalviso's new drug application.
Revenue in the recent period fell to $226,000, from $27.4 million a year ago, on lower collaboration payments.
Wall Street expected a loss of $0.30 a share on revenue of $590,000.
AcelRx said it will meet with regulators to clarify potential objectives of further study of Zaviso.
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