Radius puts off its FDA filing to be 'respectful' of holiday plans

Radius CEO Robert Ward

Radius Health's ($RDUS) shares slipped on Tuesday after the company said it was postponing a planned FDA filing for its osteoporosis drug. But CEO Robert Ward, looking to calm investors, said the delay was unrelated to clinical data and instead a precautionary move to avoid rushing at the end of the year.

The drug, abaloparatide, is an injection designed to treat osteoporosis in postmenopausal women. A 12-month Phase III trial on abaloparatide is slated to wrap next month, and Radius had said as recently as Nov. 5 that it planned to quickly analyze the resulting data and file for FDA approval before year's end. On Tuesday, however, the company put out word that it now plans to begin that analysis in January, moving its FDA submission to some time later in the first quarter.

Radius provided no reasons for the delay in its statement, but Ward told Bloomberg in an interview that the company chose to postpone its filing in an effort to avoid year-end scrambling, which "might unintentionally create risk."

"Part of our assessment was: Is this the time to ask everyone in our supply chain to work on an accelerated basis over a period of time when they all had personal plans?" Ward said. "Or was it better for us to pick a timeline that was more respectful for what the overall work-life balance might be across our whole supply chain?"

Radius' shares have fallen more than 10% since the announcement. The company, which went public last year, still remains one of the major Wall Street success stories of the recent biotech IPO boom, trading at nearly 800% of its debut price.

Despite the U.S. delay, Radius came through on its plans to submit abaloparatide for European approval before the end of the year, filing its application this week.

- read the statement
- here's the Bloomberg story

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