| Drug / Therapy | nivolumab (Opdivo) |
| Indication | neoadjuvant NSCLC sNDA |
| Decision Type | PDUFA |
| Conditions | neoadjuvant NSCLC sNDA |
| Interventions | nivolumab (Opdivo) |
Bristol-Myers Squibb (BMY) operates in the Oncology sector. The current BTS Score is 35 (Grade: F).
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.
The PDUFA date for nivolumab (Opdivo) by Bristol-Myers Squibb (BMY) is scheduled for January 20, 2027. This is the target date for the FDA to make a decision on this application.
nivolumab (Opdivo) is being developed by Bristol-Myers Squibb for the treatment of neoadjuvant NSCLC sNDA. It is under FDA review.
If nivolumab (Opdivo) receives FDA approval, Bristol-Myers Squibb (BMY) would be able to market the drug in the United States for neoadjuvant NSCLC sNDA. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for BMY on DilutionWatch at dilutionwatch.com/stock/BMY.html.
You can view the full BiotechSigns company profile for Bristol-Myers Squibb (BMY) at biotechsign.com/app/company/BMY, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
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. BiotechSigns is not a registered investment advisor.