FBIOP — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• Emrosi (Minocycline Hydrochloride Modified Release Capsules, 40 mg, also known as DFD-29, for the treatment of rosacea)

• ●In April 2026, our partner company Journey announced that approximately 85% of all commercial lives in the United States have access to Emrosi™ (Minocycline Hydrochloride Modified Release Capsules, 10 mg immediate release and 30 mg extended release) after contracting with a third major group purcha…

• ZYCUBO (copper histidinate for Menkes disease, formerly known as CUTX-101)

• ●On January 13, 2026, we announced the FDA approved ZYCUBO (copper histidinate, also referred to as CUTX-101) for the treatment of Menkes disease in pediatric patients. A priority review voucher (“PRV”) was issued in connection with FDA approval and, pursuant to the transaction with Sentynl, was tra…

• ●Previously, in October 2025, Cyprium announced that the FDA had issued a complete response letter (“CRL”) to Sentynl for CUTX-101 (copper histidinate for Menkes disease). The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured and did not cite any other appr…

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• ●For the nine months ended September 30, 2025 and 2024, net revenue was $47.2 million and $42.6 million, respectively, and is primarily related to the sale of Journey’s marketed products.

• ●For the nine months ended September 30, 2025, net revenue included $1.4 million related to Avenue’s termination of its license agreement with AnnJi Pharmaceutical Co. Ltd. (“AnnJi”), and $0.6 million related to Journey’s supply of Amzeeq to Cutia.

• Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg, also known as DFD-29, for the treatment of rosacea)

• ●In July 2025, our partner company Journey announced expanded payer coverage for Emrosi™ (Minocycline Hydrochloride Extended-Release Capsules, 40mg) where 65% of the 187 million commercial lives in the United States now have pharmacy benefit coverage for Emrosi.

• ●In May 2025, our partner company, Checkpoint, was acquired by Sun Pharmaceutical Industries, Inc. (“Sun Pharma”) for $4.10 per share in cash plus a contingent value right of up to $0.70 per share upon the achievement of EU approval of Checkpoint’s principal drug product candidate. Fortress received…

Text added vs the prior filing · source: 10-Q · 2026-05-14

• for our product candidates and the ability to produce and distribute our products in the volume needed to both meet commercial demand and build inventory to mitigate possible supply disruptions.

• and prospects. Even if we are allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot assure you that our product candidates will receive the requisite approvals for commercialization in a timely manner, or at all.

• Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.

• The current presidential administration has signaled, and may further implement, significant shifts in policies that directly impact the life sciences industry, including policies relating to FDA regulation and enforcement, drug approval and review processes, reimbursement and pricing (including Med…

• Potential changes may include, among others: (i) modifications to standards, procedures or timelines for the review, clearance, approval or post-market oversight of drugs; (ii) changes to policies on real-world evidence, accelerated approval, emergency use authorizations, and clinical trial requirem…

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• throughout this filing, the words “we”, “us” and “our” may refer to Fortress individually, to one or more subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

• securities or convertible debt. We cannot assure you that we would be able to obtain such additional financing on terms acceptable to us, if at all. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway would likely result in new competitive products reaching the market more quickly…

• On July 25, 2024, we, as borrower, entered into a $50.0 million senior secured credit agreement (the “Oaktree Agreement”) with Oaktree Fund Administration, LLC and the lenders from time-to-time party thereto (collectively, “Oaktree”). We borrowed $35.0 million under the Oaktree Agreement on the date…

• companies’ ability to enter into certain transactions or arrangements that management otherwise believes would be in our or such partner companies’ best interests, such as dispositions that would result in cash inflows to Fortress and/or our subsidiaries and partner companies, or acquisitions or fin…

• ●one or more of our development-stage product candidates is approved for commercial sale and we decide to commercialize such product(s) ourselves, due to the need to establish the necessary commercial infrastructure to launch and commercialize this product without substantial delays, including hirin…