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FBIO FORTRESS BIOTECH INC US FDA Inspections 8-K Filing

FRTR

FB

FORTRESS BIOTECH INC

(FBIO)

2025 8-K

FDA Response Update

Financial Update

FDA Response Update

Financial Update

Regulatory Compliance

Appointed Directors

Merger of Equals

Earnings Releases

Management Change

Financial Results

Merger Agreement

FDA Action Delay

FDA Application Accepted

Financial Results

Financial Results

Credit Agreement and Warrants

Acquisition of Crystalys Th...

Bylaws Amendment

Annual Meeting Approval

Earnings Report

Financial Results Announcement

Departure of Director

Compliance and Program Tran...

Reverse Stock Split

Financial Results and Bylaw...

Departure of Directors or C...

Agreement to Lower Exercise...

Financial Results Announcement

Special Meeting of Stockhol...

Earnings Report

Investment Offering

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Fortress Biotech, Inc. reported that on October 1, 2025, the FDA issued a Complete Response Letter for their drug CUTX-101. However, on November 14, 2025, it was announced that Sentynl Therapeutics has resubmitted the NDA for this drug, potentially allowing Fortress to earn up to $129 million in royalties and milestones.

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FORTRESS BIOTECH INC

2025

8 K

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