Biotech & Genomic Medicine▲
Zymeworks Shares Rise Ahead of Key FDA Decision on Zanidatamab
Zymeworks shares climbed nearly 4.0% in pre-market trading as investors positioned themselves ahead of an important U.S. regulatory decision on zanidatamab, expected the following day. The FDA's PDUFA target action date for zanidatamab, a bispecific HER2-targeting antibody developed alongside Jazz Pharmaceuticals, is August 25, 2026, with the regulator reviewing the treatment for first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. Approval would immediately trigger a $250 million U.S. regulatory milestone payment, with up to an additional $190 million possible through regulatory milestones in other markets. Citi placed the stock on an upside 90-day catalyst watch earlier in August, while Truist and Wells Fargo have increased their price targets ahead of the PDUFA date. Zymeworks is also pursuing a roughly $929 million all-cash acquisition of Theravance Biopharma, expected to close in the second half of 2026, which would add commercial cash flows from the COPD treatment YUPELRI.