PDUFALLY

retatrutide FDA Decision: Eli Lilly and Company (LLY)

Decision Date
November 20, 2026
125 days away

Drug Overview

Drug / Therapyretatrutide
Indicationobesity GLP-1/GIP/glucagon
Decision TypePDUFA
Conditionsobesity GLP-1/GIP/glucagon
Interventionsretatrutide

Company Overview

Eli Lilly and Company (LLY) operates in the Diabetes/Oncology sector. The current BTS Score is 43 (Grade: D).

Dilution Risk Assessment

Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.

Frequently Asked Questions

Q:When is the PDUFA date for retatrutide?

The PDUFA date for retatrutide by Eli Lilly and Company (LLY) is scheduled for November 20, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is retatrutide used for?

retatrutide is being developed by Eli Lilly and Company for the treatment of obesity GLP-1/GIP/glucagon. It is under FDA review.

Q:What happens if retatrutide gets FDA approval?

If retatrutide receives FDA approval, Eli Lilly and Company (LLY) would be able to market the drug in the United States for obesity GLP-1/GIP/glucagon. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.

Q:What is the dilution risk for LLY?

Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for LLY on DilutionWatch at dilutionwatch.com/stock/LLY.html.

Q:Where can I find more information about Eli Lilly and Company?

You can view the full BiotechSign company profile for Eli Lilly and Company (LLY) at biotechsign.com/app/company/LLY, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.

Disclaimer

This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSign is not a registered investment advisor.