CAMBRIDGE, Mass. -- Shares of Curis Inc. were off 48.1%, or $6.25, to $6.75 late Tuesday morning, following news that the company's OP-1 implant for fractures of the tibia received a "Not-Approvable" letter from the Food and Drug Administration.
In a press release Tuesday, the medical technology company said its licensee for OP-1, Stryker Corp. (SYK), received the FDA letter, which cited statistical reporting problems in the Pre-Market Approval application.
Stryker reported the FDA letter Jan. 29, but did not mention Curis as the licensee.
The FDA recommended that Stryker conduct a new study, and the company intends to continue to pursue approval and hopes to meet with the FDA shortly, Curis said.
New York Stock Exchange-listed shares of Stryker traded recently at $46.36, down 56 cents, or 1.3%, on composite volume of 641,500 shares. Average daily volume is 900,907. |
