ViroPharma Incorporated (NASDAQ: VPHM) is seeing its shares heading south after the U.S. Food and Drug Administration issued a “complete response letter” to the company regarding the Cinryze (C1 Esterase Inhibitor) industrial scale manufacturing expansion activities.
The FDA’s three points tied to the company’s cleaning validation for industrial scale manufacturing. Apparently, only one point requires new effort that was not planned and the company believes that this can be completed in a short period of time. Unfortunately, the FDA has not completed its review of updated responses given by the company just in January.
What is shielding the company here is that there are not remaining technical issues and ViroPharma plans to update the progress and offer more timing issues when it reports earnings later this month.
VioPharma shares are down 3.5% at $29.44 in the pre-market but the 52-week range is $14.62 to $31.00. Shares were earlier down by 5%, so the response has been less of concern so far but we have only about 21,800 shares that have been traded so far in the pre-market and this one trades about 1.2 million shares per day on average.
Keep in mind that the company is profitable and it has a market value of $2.1 billion and Thomson Reuters has a consensus price target objective of $32.15.
JON C. OGG
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