FINWIRES · TerminalLIVE
FINWIRES

U.S. FDA Grants Priority Review to Takeda Pharmaceutical's Zasocitinib NDA for Plaque Psoriasis

By

The U.S. Food and Drug Administration (FDA) accepted Takeda Pharmaceutical's (TYO:4502) new drug application (NDA) for zasocitinib under priority review for adults with moderate‑to‑severe plaque psoriasis, according to a Monday filing with the Japanese bourse.

The application is supported by Phase III LATITUDE PsO 3001 and 3002 trials, which met all primary and ranked secondary endpoints. About 70% of patients achieved clear or nearly clear skin by Week 16, with improvements seen from Week 4 and sustained through Week 52, the filing said.

Shares of Takeda Pharmaceutical added over 1% at market close.

What else is happening in Asia?

Asia

Orora Chief Safety, Sustainability, Governance Officer to Step Down at End of Year

Orora (ASX:ORA) said Ann Stubbings plans to step down as chief safety, sustainability, and governance officer, effective Dec. 31, after more than 13 years with the packaging products firm, according to a Monday filing with the Australian bourse.In addition, Susannah Jobling Hodgens will be appointed as chief legal officer, the company said. Hodgens has worked with Orora for 13 years in senior legal and governance roles, most recently as general counsel and alternate company secretary.Orora shares gained nearly 1% in recent Monday trade.

ASX:ORA
Asia

Biokin Pharma Enrolls First Patient in Phase Three Trial for Breast Cancer Drug; Shares Up 4%

Sichuan Biokin Pharmaceutical (SHA:688506) enrolled the first subject for the third-phase clinical trial of biologic drug T-Bren for injection, according to a weekend filing with the Shanghai bourse.The trial evaluates T-Bren combined with pertuzumab versus standard chemotherapy in neoadjuvant treatment of HER2-positive breast cancer, according to a weekend filing with the Shanghai bourse.Shares of the pharmaceutical company rose 4% in recent trade.

SHA:688506
Asia

Market Chatter: Korea Exchange to Extend Trading Hours till 8PM

South Korea's main stock market, the Korea Exchange, will enable trading till 8 pm following the regular close at 3:30 pm from Monday, in its move toward 24-hour trading, Bloomberg News reported Sunday.This decision opens 2,400 Korea Composite Stock Price Index, or Kospi, and Kosdaq stocks for evening trades, which include short-selling. The move excludes exchange-traded funds, the report said.The Korea Exchange plans to introduce pre-market trading by the end of next year, it said.(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

^KOSDAQKOSPI