FDA Removes Partial Hold On Zentalis Pharmaceuticals' Azenosertib Studies In Patients With Gynecological Cancers

Monday, the FDA lifted the partial clinical hold on studies of Zentalis Pharmaceuticals, Inc.’s ZNTL azenosertib, the company’s novel, selective, and orally bioavailable inhibitor of WEE1.

The FDA has cleared the company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan.

Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible.

Also Read: Zentalis Gears Up for Phase 3 Study of Azenosertib after Positive Phase 1b Outcomes.

“We are grateful to the FDA for their collaboration and review of our complete response package, which included a comprehensive safety assessment of the azenosertib program,” said Kimberly Blackwell, Chief Executive Officer.

At a corporate event later this year, Zentalis will present azenosertib monotherapy data and provide additional updates to azenosertib clinical development and other data presentation timelines.

The company remains on track to meet all previously disclosed data guidance for the remainder of 2024. 

In June this year, the FDA issued a partial on three azenosertib studies for solid tumors, platinum-resistant ovarian cancer, and uterine serous carcinoma.

The update followed two recent deaths due to presumed sepsis in the Phase 2 ZN-c3-005 DENALI study in platinum-resistant ovarian cancer.

Price Action: ZNTL stock is up 41.7% at $4.59 during the premarket session at last check Monday.

Photo via Shutterstock

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