Dj Zymeworks Inc Com, Inst Holders, 3Q 2024 (Zyme)

By Ben Glickman

Shares of Zymeworks rose early Thursday after the cancer therapy it is developing with Jazz Pharmaceuticals received accelerated regulatory approval for treating forms of biliary tract cancer.

Zymeworks' stock was up 8.3% to $15.75 in pre-market trading. Shares are up about 40% this year as of Wednesday's close.

The U.S. Food and Drug Administration granted Ziihera, an antibody treatment, accelerated approval for injection for intravenous use in treating adults with certain forms of biliary tract cancer.

Zymeworks first developed the molecule, and in 2022 entered a license and collaboration deal with Jazz for exclusive development and commercialization rights to the compound in most countries. Under the licensing deal, Zymeworks has earned a milestone payment of $25 million based on FDA approval of Ziihera in BTC.

Jazz shares were up about 2.3% in pre-market trading.

BeiGene has the compound's license in Asia Pacific territories.

The company is still eligible for up to $500 million in regulatory milestone payments and $862.5 million in commercial milestone payments from Jazz. Zymeworks will also receive tiered royalties on sales.

Zymeworks said Ziihera was the first candidate in its pipeline to receive FDA approval.

Ziihera, known by generic name zanidatamab, is also being evaluated as a treatment option for patients with other solid tumors.

Write to Ben Glickman at ben.glickman@wsj.com