FibroGen Down; FDA Extends Review Period for Roxadustat
By Michael Dabaie
FibroGen Inc. shares were down 14% to $37.66 in late morning
The company said after the market close Friday that the Food and
Drug Administration extended the review period of the new drug
application for roxadustat for the treatment of anemia of chronic
kidney disease by three months.
The updated Prescription Drug User Fee Act action date is March
20, 2021, the company said.
FibroGen said the FDA is close to finalizing its review of the
NDA. FibroGen is submitting additional analyses of existing
roxadustat clinical data, which require an extension of the
original PDUFA date.
"FibroGen is working closely with the FDA, in collaboration with
our partner, AstraZeneca, to support the final review of the new
drug application for roxadustat," said FibroGen Chief Executive
AstraZeneca and FibroGen "are committed to working with the FDA
and have agreed to submit the additional clarifying analyses as
soon as possible to assist with the completion of labelling
discussions," AstraZeneca said.
"While there are numerous explanations for the PDUFA delay, none
of them are good (especially considering how late it came in the
review cycle)," Raymond James said in a note dated Friday. The firm
maintained the stock at underperform.
"We believe that the delay has a positive read-through to
approvability; our confidence is bolstered by precedent cases of
the FDA extending PDUFA dates and ultimately approving the delayed
applications," Mizuho Securities USA said in an analyst note.
Mizuho said it reaffirmed its buy rating and $72 price target.
The firm said it "would buy shares on weakness if the market opens
lower Monday morning."
Stifel said it reiterates its buy rating on FibroGen shares and
$70 target price. "Following FDA's late request for additional
analysis of already-existing roxadustat data to complete NDA
review, FibroGen's submission will be considered a 'major
amendment', consequently extending the PDUFA date," Stifel said
"Ultimately, we believe a request for additional analysis [as
opposed to a complete response letter] suggests FDA is leaning
towards roxa approval in 1Q21," Stifel said.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires
December 21, 2020 12:10 ET (17:10 GMT)
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