Zentalis Pharmaceuticals Inc. (ZNTL) Thursday announced that its lead drug candidate Azenosertib has been granted FDA's Fast Track designation for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients who are Cyclin E1 positive.
Azenosertib, a novel, selective, and orally bioavailable inhibitor of WEE1 is currently being evaluated as a monotherapy and in combination clinical studies in ovarian cancer and additional tumor types. It has demonstrated anti-tumor activity in gynecological malignancies, the company noted.
The Fast Track designation is expected to expedite the drug's development and review process, allowing for more frequent interactions with the FDA and the potential for accelerated approval.
Zentalis also announced the publication of a paper in npj Precision Oncology, which highlights Cyclin E1/CDK2 activation as a potential biomarker for identifying patients most likely to benefit from Azenosertib.
The company plans to present updated clinical data and provide a regulatory update at a corporate event on January 29, 2025.
Azenosertib is currently being evaluated in several clinical studies, including monotherapy trials and combination treatments, with additional data expected in the coming months. If successful, Azenosertib could offer a new treatment option for patients with Primary Peritonial Cancer and other tumors with high genomic instability.
ZNTL closed Wednesday's (Jan. 08, 2025) trading at $2.78, down 7.02%. In after-hours trading, the stock was up 1.43% at $2.82
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