(Reuters) - Shares of Impax Laboratories Inc (IPXL.O) fell as much as 10 percent on Tuesday, after U.S. health regulators denied approval to the company’s Parkinson’s drug and asked for a reinspection of its Hayward manufacturing facility.
The drugmaker said on Monday that the U.S. Food and Drug Administration denied approval due to the involvement of the Hayward plant in the development, supportive manufacturing and distribution of the drug, Rytary.
However, Impax said it withdrew the plant as an alternative facility for the commercial production of the drug.
“(Impax) has little clarity at this point on what may be required after successful Hayward reinspection, so Rytary timing is totally ambiguous,” Jefferies & Co’s Corey Davis said.
Davis said the process for approving the drug may be delayed by a year, and cut his target price on the company’s stock to $18 from $21.
Canaccord Genuity also cut its price target to $25 from $27.
Rytary was tested for the potential symptomatic treatment of Parkinson’s disease.
Impax shares fell to $18.90 on the Nasdaq on Tuesday morning — their lowest in almost a year. They were later trading down 7.7 percent at $19.40.
Reporting By Adithya Venkatesan