CymaBay Shares Rise 7% After Revised Breakthrough Therapy Designation
23 Outubro 2023 - 1:52PM
Dow Jones News
By Chris Wack
CymaBay Therapeutics shares were up 7% to $14.53 on Monday after
the company said the Food and Drug Administration revised the
originally granted Breakthrough Therapy Designation for seladelpar
to now reflect treatment of primary biliary cholangitis, including
pruritus, in adults without cirrhosis or with compensated
cirrhosis.
The stock hit a 52-week high of $18.20 on Sept. 12, and is up
338% in the past 12 months.
The biopharmaceutical company said seladelpar is the only
potent, selective, orally active delpar, with phase 3 results
demonstrating a statistically significant improvement in
PBC-related cholestatic pruritus.
Breakthrough Therapy Designation is granted by the FDA to
investigational agents intended to treat a serious or
life-threatening disease or condition, and whose preliminary
clinical evidence may demonstrate substantial improvement on at
least one clinically significant endpoint over available
therapy.
The FDA's original Breakthrough Therapy Designation for
seladelpar was granted in 2019 and was based on preliminary results
from a Phase 2 clinical trial. That trial showed that seladelpar
was associated with a substantial reduction in serum alkaline
phosphatase.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 23, 2023 12:37 ET (16:37 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Cymabay Therapeutics (NASDAQ:CBAY)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Cymabay Therapeutics (NASDAQ:CBAY)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024
