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Biotech Stocks Facing FDA Decision In August

Pfizer
Pfizer

Pfizer Inc. (PFE) has sought FDA approval for Lorlatinib in the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer previously treated with one or more ALK tyrosine kinase inhibitors, and a decision is expected in August.

Though no specific date for the decision in August has been announced, we estimate that the decision could be announced on August 12 based on the review timeline of 6 months from the acceptance of the New Drug Application for priority review.

Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors like Pfizer’s very own non-small cell lung cancer drug Xalkori and to penetrate the blood brain barrier.

Analysts expect Lorlatinib to become a blockbuster.

PFE closed Wednesday’s (Jul 25) trading at $37.99, up 0.77%.