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Fortress Biotech (FBIO) FDA Events

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FDA Events for Fortress Biotech (FBIO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Fortress Biotech (FBIO). Over the past two years, Fortress Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Cosibelimab, CUTX-101, MB-101, MB-106, MB-107, and Triplex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Fortress Biotech's Drugs in FDA Review

Cosibelimab (formerly CK-301) - FDA Regulatory Timeline and Events

Cosibelimab (formerly CK-301) is a drug developed by Fortress Biotech for the following indication: Metastatic cutaneous squamous cell carcinoma (mCSCC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CUTX-101 - FDA Regulatory Timeline and Events

CUTX-101 is a drug developed by Fortress Biotech for the following indication: Menkes disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MB-101 - FDA Regulatory Timeline and Events

MB-101 is a drug developed by Fortress Biotech for the following indication: Leptomeningeal brain tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MB-106 - FDA Regulatory Timeline and Events

MB-106 is a drug developed by Fortress Biotech for the following indication: Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MB-107 - FDA Regulatory Timeline and Events

MB-107 is a drug developed by Fortress Biotech for the following indication: Newly diagnosed infants with X-linked severe combined immunodeficiency (XSCID) or bubble boy disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Triplex - FDA Regulatory Timeline and Events

Triplex is a drug developed by Fortress Biotech for the following indication: Adults Co-Infected with HIV and CMV. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Fortress Biotech FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Fortress Biotech (FBIO) has reported FDA regulatory activity for the following drugs: MB-106, MB-101, MB-107, CUTX-101, Triplex and Cosibelimab (formerly CK-301).

The most recent FDA-related event for Fortress Biotech occurred on July 7, 2025, involving MB-101. The update was categorized as "Designation Grant," with the company reporting: "Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma (astrocytomas) and glioblastoma (GBM)."

Current therapies from Fortress Biotech in review with the FDA target conditions such as:

  • Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL) - MB-106
  • Leptomeningeal brain tumors - MB-101
  • Newly diagnosed infants with X-linked severe combined immunodeficiency (XSCID) or bubble boy disease - MB-107
  • Menkes disease - CUTX-101
  • Adults Co-Infected with HIV and CMV - Triplex
  • Metastatic cutaneous squamous cell carcinoma (mCSCC) - Cosibelimab (formerly CK-301)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:FBIO) was last updated on 7/10/2025 by MarketBeat.com Staff
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