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Biotech Stocks Facing FDA Decision In April 2023

AstraZeneca
AstraZeneca

A panel of outside advisers to the FDA is scheduled to review AstraZeneca PLC (AZN) and Merck Inc.’s (MRK) supplemental new drug application for Lynparza on April 28, 2023.

The proposed indication for Lynparza is in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer.

Lynparza, which is being jointly developed and commercialized by AstraZeneca and Merck, is already approved in the U.S. for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone.

Ovarian cancer, fallopian tube cancer, peritoneal cancer, breast cancer, and pancreatic cancer are the other approved indications of Lynparza.

The drug brought home annual product sales of $2,638 million for AstraZeneca in 2022, up 12% over the prior year.

AZN closed Thursday’s trading at $69.20, up 0.82%.