Phase 1NTLANCT06379789

A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) FDA Decision: Intellia Therapeutics (NTLA)

Decision Date
August 14, 2034
2949 days away

Drug Overview

Drug / TherapyA Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265)
Indication
Decision TypePhase 1
Trial PhasePhase 1
ClinicalTrials.govNCT06379789

Company Overview

Intellia Therapeutics (NTLA) operates in the Gene Editing sector. The current BTS Score is 61 (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 1 date for A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) ?

The Phase 1 date for A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) by Intellia Therapeutics (NTLA) is scheduled for August 14, 2034. This is the target date for the FDA to make a decision on this application.

Q:What is A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) used for?

A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) is being developed by Intellia Therapeutics for the treatment of its target indication. It is currently in Phase 1 clinical trials.

Q:What happens if A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) gets FDA approval?

If A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) receives FDA approval, Intellia Therapeutics (NTLA) 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 1 date closely.

Q:What is the dilution risk for NTLA?

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

Q:Where can I find more information about Intellia Therapeutics?

You can view the full BiotechSign company profile for Intellia Therapeutics (NTLA) at biotechsign.com/app/company/NTLA, 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.