Phase 2COLLNCT04655118

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis FDA Decision: Collegium Pharmaceutical, Inc. (COLL)

Decision Date
June 30, 2025
339 days ago

Drug Overview

Drug / TherapyStudy of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Indication
Decision TypePhase 2
Trial PhasePhase 2
ClinicalTrials.govNCT04655118

Company Overview

Collegium Pharmaceutical, Inc. (COLL) operates in the Biotech / Pharma sector. The current BTS Score is 43 (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 Phase 2 date for Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis?

The Phase 2 date for Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis by Collegium Pharmaceutical, Inc. (COLL) is scheduled for June 30, 2025. This is the target date for the FDA to make a decision on this application.

Q:What is Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis used for?

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis is being developed by Collegium Pharmaceutical, Inc. for the treatment of its target indication. It is currently in Phase 2 clinical trials.

Q:What happens if Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis gets FDA approval?

If Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis receives FDA approval, Collegium Pharmaceutical, Inc. (COLL) 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 2 date closely.

Q:What is the dilution risk for COLL?

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

Q:Where can I find more information about Collegium Pharmaceutical, Inc.?

You can view the full BiotechSigns company profile for Collegium Pharmaceutical, Inc. (COLL) at biotechsign.com/app/company/COLL, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.

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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.