Shares of KV Pharmaceutical Co. sank Wednesday after the Food and Drug Administration decided to delay its decision on Gestiva, a drug intended to prevent premature birth, until April.
KV's Class A shares dropped nearly 25 percent, or 56 cents, to $1.72 in morning trading.
The Bridgeton, Mo., drugmaker, which has acquired the rights to Gestiva from Hologic Inc., said it remains confident in the drug's approval, and it believes positive action from the FDA is likely on or before its new decision date of April 13.
Gestiva is intended to prevent premature birth in women who are pregnant with a single fetus and have experienced spontaneous premature birth before. KV said Hologic resubmitted an application for the drug last July, and the FDA had set a Jan. 13 decision date but recently asked for more information, which was provided Monday.
KV's statement did not detail what additional information the FDA requested.
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