[EQUITIES] ‘Daewoong Pharma’s USFDA approval delayed’
[THE INVESTOR] Daewoong Pharmaceutical’s botulinum toxin will need more time to gain approval from the US Food and Drug Administration, said eBEST Investment and Securities on May 17, downgrading the recommendation to a “hold” from a “buy” and lowering the target price to 230,000 won (US$213) from 260,000 won.
USFDA issued a complete response letter to its US partner Evolus, said analyst Shin Jae-hun explaining that it will take 90 days to apply for a reevaluation and final approval could be obtained within six months at the earliest.
Although Evolus emphasized that the CRL centered solely on chemistry, manufacturing and controls process deficiencies, its stock price tumbled 29.96 percent at NASDAQ.
Winning approval in 9 months is the best-case scenario, underlined the analyst pushing back the expected timeline to the first quarter next year from August this year.
By Hwang You-mee (firstname.lastname@example.org)