BeyondSpring Shares Plummet After FDA Rejects Plinabulin
December 01 2021 - 11:04AM
Dow Jones News
By Colin Kellaher
Shares of BeyondSpring Inc. lost more than half of their value
Wednesday after the U.S. Food and Drug Administration turned away
the company's application seeking approval of its lead asset
plinabulin to combat a dose-limiting toxicity related to
chemotherapy.
The New York biopharmaceutical company, which was seeking
approval of plinabulin in combination with granulocyte
colony-stimulating factor for the prevention of
chemotherapy-induced neutropenia, said the FDA determined that a
second study would be needed to support the proposed
indication.
BeyondSpring shares were recently changing hands at $6.07, down
53%, after hitting a 52-week low of $5.50 earlier in the session.
The stock is more than 80% down from the 52-week intraday high of
$33 it hit on Aug. 31.
Analysts at H.C. Wainwright said they were surprised by the
rejection, given that BeyondSpring had received
breakthrough-therapy designation for plinabulin in the indication
and priority review for the application.
H.C. Wainwright cut its recommendation on BeyondSpring shares to
neutral from buy and removed its $65 price target, saying the
requirement of a second study puts its investment thesis on
hold.
BeyondSpring said it is confident in its efficacy and safety
data for plinabulin, and that it plans to work closely with the FDA
on a future clinical pathway, which may include a second study.
H.C. Wainwright said it believes BeyondSpring remains
cash-strong for any future business development decisions, and that
the chemotherapy-induced neutropenia program is an "attractive,
significantly derisked asset for potential suitors."
BeyondSpring is also studying plinabulin in combination with
docetaxel in certain patients with non-small cell lung cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 01, 2021 10:49 ET (15:49 GMT)
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