Ariad Announces FDA Has Given Clearance To Begin Clinical Development Trial

Shares of Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA) hit a new 52-week low of $4.72 on Monday and was trading lower by more than 4 percent.

Ariad Pharmaceuticals announced earlier in the day that the U.S. Food and Drug Administration has completed its review of the company's Investigational New Drug application for AP32788.

AP32788 is an investigational oral tyrosine kinase inhibitor (TKI) of activating mutations in EGFR and HER2. The molecule was designed to address the unmet need in patients with non-small cell lung cancer (NSCLC) driven by exon 20 insertion mutations in EGFR and HER2, and is ARIAD's fourth internally discovered oncology IND to be cleared for clinical development.

The FDA has given the necessary clearance for Ariad to begin a Phase 1/2 clinical trial. The company stated that it expects to begin such trials in the second quarter of 2016.

"ARIAD scientists designed AP32788 using our integrated drug discovery program to target cancer orphan subsets that are genetically defined but have no current targeted treatment options. This compound specifically addresses the needs of patients with NSCLC driven by EGFR exon 20 or HER2 mutations, who currently have a poor prognosis and limited treatment options," stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. "Data on the preclinical characterization of AP32788 have been submitted for presentation at the American Association of Cancer Research annual meeting in April."