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 firstname.lastname@example.org
(END) Dow Jones Newswires