| Drug / Therapy | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| Indication | — |
| Decision Type | Phase 3 |
| Trial Phase | Phase 3 |
| ClinicalTrials.gov | NCT03126916 |
Spectral Medical (SMA) operates in the Dialysis Sepsis sector. The current BTS Score is 62 (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 Phase 3 date for Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) by Spectral Medical (SMA) is scheduled for September 30, 2030. This is the target date for the FDA to make a decision on this application.
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) is being developed by Spectral Medical for the treatment of its target indication. It is currently in Phase 3 clinical trials.
If Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) receives FDA approval, Spectral Medical (SMA) would be able to market the drug in the United States for its target indication. This typically leads to significant stock price movement for biotech companies. Investors should monitor the Phase 3 date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for SMA on DilutionWatch at dilutionwatch.com/stock/SMA.html.
You can view the full BiotechSigns company profile for Spectral Medical (SMA) at biotechsign.com/app/company/SMA, 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.