The timeline for GC’s processed blood product in gaining approval from the US Food and Drug Administration is likely to be pushed back, said NH Investment and Securities on Sept. 27, downgrading the recommendation to a “hold” from a “buy” and lowering the target price to 220,000 won (US$197.66) from 240,000 won.
The FDA has sent a second complete response letter for its intravenous immunoglobulin IVIG-SN, and will gaining approval in the second quarter next year at the earliest. In worst-case scenario, the process could be delayed by another year, possibly affecting the operations of its Canadian factory, said analyst Koo Wan-seong.
Investors should approach the stocks conservatively until details of FDA’s requirements are known, he said adding that the pharmaceutical company’s earnings per share is inevitably adjusted due to the delay in generating revenue in the US.