| Drug / Therapy | setrusumab |
| Indication | osteogenesis imperfecta |
| Decision Type | PDUFA |
| Conditions | osteogenesis imperfecta |
| Interventions | setrusumab |
Ultragenyx Pharmaceutical (RARE) operates in the Rare Disease sector. The current BTS Score is 63 (Grade: C).
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 setrusumab by Ultragenyx Pharmaceutical (RARE) is scheduled for September 25, 2026. This is the target date for the FDA to make a decision on this application.
setrusumab is being developed by Ultragenyx Pharmaceutical for the treatment of osteogenesis imperfecta. It is under FDA review.
If setrusumab receives FDA approval, Ultragenyx Pharmaceutical (RARE) would be able to market the drug in the United States for osteogenesis imperfecta. 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 RARE on DilutionWatch at dilutionwatch.com/stock/RARE.html.
You can view the full BiotechSigns company profile for Ultragenyx Pharmaceutical (RARE) at biotechsign.com/app/company/RARE, 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.