Eli Lilly (LLY) Stock: Why The Price Fell Today

By Amit Chowdhry ● Feb 8, 2022
  • The stock price of Eli Lilly And Co (NYSE: LLY) fell by 1.49% today. This is why it happened.

The stock price of Eli Lilly And Co (NYSE: LLY) fell by 1.49% today. Investors appear to be responding negatively to a flag from the FDA over trial data associated with the PD-1 inhibitor Tyvyt (sintilimab) ahead of an advisory committee meeting scheduled for Thursday to decide on the marketing application in lung cancer, according to Seeking Alpha.

Eli Lilly had partnered with Innovent Biologics for seeking FDA approval for Tyvyt to treat late-stage non-squamous non-small cell lung cancer (NSCLC). But the data from the Phase 3 ORIENT-11 trial conducted in China is unlikely going to support the approval.

“The patient population in ORIENT-11, as a single country trial, does not reflect the diversity of the American population, with both known and unknown differences in intrinsic and extrinsic factors,” says the filing. “Acceptance of single country foreign data which does not reflect the diversity of a U.S. population challenges the widespread industry commitment to patient equity and inclusion of underrepresented populations. While clinical site inspections may be performed, they cannot fully capture the heterogeneity of data quality and study conduct across numerous clinical sites. Investigators in ORIENT-11 have had limited prior interactions with the FDA and an unknown level of prior participation in MRCTs that led to FDA approvals. Importantly, the extent of past participation in MRCTs may provide added confidence in trial conduct and data integrity. The NSCLC treatment landscape includes many front-line immunotherapy options conferring advantages in OS whereas ORIENT-11 was powered for PFS.”

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