MOUNTAIN VIEW, Calif. (AP) — Shares of drug developer MAP Pharmaceuticals Inc. gained Friday after encouraging regulatory news on what could become the company's first approved product.
THE SPARK: The U.S. Food and Drug Administration accepted the company's application for approval to sell its experimental migraine drug, Levadex, MAP said. MAP hopes to launch the drug next year.
THE BIG PICTURE: Levadex would become the Mountain View, Calif., company's first product, potentially giving MAP steady revenue. MAP is developing Levadex through a partnership with Allergan Inc.
In March, the FDA said it could not approve Levadex until the company addressed concerns related to manufacturing and other issues. But the resubmitted application responds to the issues raised by the FDA, MAP said late on Wednesday. The agency will aim to approve the drug, or not, by April.
THE ANALYSIS: Levadex could provide annual sales of as much as $500 million if it's approved, said J.P.Morgan analyst Jessica Fye in a research note. She is optimistic about its chances of approval.
SHARE ACTION: Up $2.60, or 20 percent, to close at $15.42 on Friday. Trading volume was about five times more than normal, despite light trading on the day after Thanksgiving.
MAP's shares have gained 17 percent this year.