Stock of the Day - May 23, 2024

Fortress Biotech (FBIO)

$3.36

-$0.06 (-1.8%)

Market Cap: $113.61M

About Fortress Biotech

Fortress Biotech, Inc., a biopharmaceutical company, develops dermatology, pharmaceutical, and biotechnology products in the United States. The company markets dermatology products, such as Qbrexza a medicated cloth towelette for the treatment of primary axillary hyperhidrosis; Accutane capsules for severe recalcitrant nodular acne; Amzeeq for severe acne vulgaris; Zilxi, a topical foam; Exelderm cream and solution for topical use; Targadox an oral doxycycline drug for adjunctive therapy for severe acne; Luxamend; sulconazole nitrate cream and solution for tinea cruris and tinea corporis; and doxycycline hyclate tablet.

It also develops late stage product candidates, such as intravenous Tramadol for the treatment of post-operative acute pain; CUTX-101, an injection for the treatment of Menkes disease; Cosibelimab for metastatic cancers; Olafertinib for the treatment of patients with EGFR mutation-positive NSCLC; CAEL-101 for the treatment of amyloid light chain amyloidosis; Triplex vaccine for cytomegalovirus; and DFD-29 for the treatment of rosacea. The company's early stage product candidates include Dotinurad for gout; MB-106 for B-cell non-hodgkin lymphoma; MB-101 for glioblastoma; MB-108 for recurrent GBM; MB-109 for refractory glioblastoma; AJ201, an androgen receptor degradation enhancer; BAER-101, a positive allosteric modulator; MB-117 for newly diagnosed x-linked severe combined immunodeficiency; and MB217 for previously transplanted; and MB-110 for RAG1 severe combined immunodeficiency. Its preclinical product candidates comprise Mayo Clinic In Vivo CAR T Platform Technology; AAV-ATP7A gene therapy; AVTS-001 gene therapy; CK-103 BET inhibitor; CEVA-D and CEVA-102; CK-302, an anti-GITR; CK-303, an anti-CAIX; and oligonucleotide platform. The company was formerly known as Coronado Biosciences, Inc. and changed its name to Fortress Biotech, Inc. in April 2015. Fortress Biotech, Inc. was incorporated in 2006 and is based in Bay Harbor Islands, Florida.

Today's Trend

Fortress Biotech (NASDAQ: FBIO) shares declined after a series of setbacks related to its CUTX-101 New Drug Application and ensuing legal inquiries.

The FDA’s Complete Response Letter for CUTX-101 did not challenge the treatment’s safety or efficacy, preserving a clear path for resubmission once manufacturing issues are resolved.
Two law firms, Portnoy and Holzer & Holzer, have launched investigations into possible securities-law violations tied to the FDA CRL announcement. Fortress Biotech Investigated by the Portnoy Law Firm Investigation of Fortress Biotech, Inc. (FBIO) Announced by Holzer & Holzer, LLC
Shares slid after the FDA cited cGMP manufacturing deficiencies in its CRL, derailing the CUTX-101 NDA process.Fortress shares slide as NDA derailed by manufacturing issues
FBIO stock plummeted on reports of the FDA’s outright rejection of its Menkes disease drug application. Fortress Biotech stock plummets after FDA rejects Menkes disease drug Fortress Biotech shares tumble after FDA rejection of Menkes treatment

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