Plus, news about Valneva and Ab&B Bio-Tech:
FDA delays decision on Stealth BioTherapeutics drug to April 29:
The company’s elamipretide is being developed for Barth syndrome, a rare genetic disorder that affects the heart and muscles. Stealth said the regulator
needed more time
to review information provided following an
advisory committee meeting
last October.
— Max Gelman
TargetRx raises $50M Series C:
The Shenzhen, China-based biotech said the
money
will fund “overseas clinical development of multiple innovative drugs.” It didn’t disclose the investors that participated in the round. TargetRx has multiple leukemia, lung cancer and solid tumor drugs in development.
Simcere Zaiming
paid the biotech about $20 million last fall for commercial rights in China to an ALK/ROS1 inhibitor.
— Kyle LaHucik
Valneva’s chikungunya vaccine succeeds in Phase 2 in children:
The vaccine, called Ixchiq, hit the
primary endpoint
of safety in a trial of 304 children between the ages of 1 and 11 years old. Valneva also tested immunogenicity, saying both the half- and full-dose cohorts were “highly immunogenic.” The full-dose group also saw higher antibody titers compared to the half dose after two weeks and four weeks. A Phase 3 study in children is expected to begin in the fourth quarter.
— Max Gelman
Vaccine maker files for HKEX listing:
Ab&B Bio-Tech, based in Taizhou, China,
filed
for an IPO on the Hong Kong Stock Exchange, joining a string of other Chinese drugmakers also
seeking to float on the HKEX
in recent weeks. The company has an approved influenza vaccine in China and is developing shots for rabies, herpes, RSV, mpox and other indications. The nearly decade-old biotech had 114 million RMB ($15.6 million) in cash and equivalents at the end of September.
— Kyle LaHucik