IPO price: $10
Oct. 23 close: $10.65
Percentage gain: 7%
Hyperion ($HPTX) fought its way to a $50 million IPO in July, giving the South San Francisco-based biotech some financial firepower to advance its lead drug, Ravicti, to the market if the FDA approves it next year. In standard biotech style, the company dropped the IPO price to $10 per share from the projected $11 to $13 range.
Indeed, few things come easily in biotech and Hyperion can testify to this reality. The FDA, which is reviewing Hyperion's Ravicti (previously known as HPA-100) for urea cycle disorders (UCD), postponed its decision date on approval of the drug from Oct. 23 to Jan. 23, 2013. Hyperion--which is developing the drug for a pair of orphan diseases, UCD and hepatic encephalopathy--was previously held up in the course of securing an SPA for the Phase III program from the FDA.
Hyperion passed a Phase II test for the drug in patients with hepatic encephalopathy earlier this year, setting the stage for pursuing further clinical evidence on the second indication for the drug after UCD.
Orphan diseases have become a hot area of drug development and Hyperion has built a case for Ravicti against UCD, which are inherited disorders that afflict 1 in 10,000 births in the U.S. and can lead to dangerous levels of ammonia in the body and, potentially, brain damage and comas. The disease robs patients of enough of an enzyme that is part of the process that converts ammonia, a toxic byproduct of protein metabolism, into urea that is removed from the body through urine.
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