PDUFACGEM

REC-994 FDA Decision: Cullinan Oncology (CGEM)

Decision Date
November 22, 2026
171 days away

Drug Overview

Drug / TherapyREC-994
Indicationspinocerebellar ataxia type 3
Decision TypePDUFA
Conditionsspinocerebellar ataxia type 3
InterventionsREC-994

Company Overview

Cullinan Oncology (CGEM) operates in the Oncology sector. The current BTS Score is 37 (Grade: D).

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 PDUFA date for REC-994?

The PDUFA date for REC-994 by Cullinan Oncology (CGEM) is scheduled for November 22, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is REC-994 used for?

REC-994 is being developed by Cullinan Oncology for the treatment of spinocerebellar ataxia type 3. It is under FDA review.

Q:What happens if REC-994 gets FDA approval?

If REC-994 receives FDA approval, Cullinan Oncology (CGEM) would be able to market the drug in the United States for spinocerebellar ataxia type 3. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.

Q:What is the dilution risk for CGEM?

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

Q:Where can I find more information about Cullinan Oncology?

You can view the full BiotechSigns company profile for Cullinan Oncology (CGEM) at biotechsign.com/app/company/CGEM, 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.