Phase 3SMANCT03126916

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) FDA Decision: Spectral Medical (SMA)

Decision Date
September 30, 2030
1579 days away

Drug Overview

Drug / TherapyTesting the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Indication
Decision TypePhase 3
Trial PhasePhase 3
ClinicalTrials.govNCT03126916

Company Overview

Spectral Medical (SMA) operates in the Dialysis Sepsis sector. The current BTS Score is 62 (Grade: C).

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 Phase 3 date for Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)?

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.

Q:What is Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) used for?

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.

Q:What happens if Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) gets FDA approval?

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.

Q:What is the dilution risk for SMA?

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.

Q:Where can I find more information about Spectral Medical?

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.

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. BiotechSigns is not a registered investment advisor.