NPS falls on Preos update
NPSP dropped $3.22 (39%) to $4.99 on Wednesday after the company updated investors post-market Tuesday on discussions with FDA related to a March approvable letter for Preos. NPSP is seeking approval of the recombinant human parathyroid hormone (PTH) for postmenopausal osteoporosis, and FDA's approvable letter had raised concerns about hypercalcemia (see BioCentury Extra, Friday March 10, 2006). Despite the agency's request for a new clinical trial at a May 1 meeting with the company, NPSP said it thinks that a reanalysis of existing data "should be sufficient."
On a conference call, NPSP President and COO Tony Coles said the company has a "very good understanding of what would be necessary for this kind of reanalysis approach," adding that "we would not proceed pell-mell down a path that we did not think had a reasonable chance of success." NPSP hopes to amend its NDA by the end of this year or early in 2007. ...