Dawson James Securities Inc.'s Senior Healthcare Analyst Jason Kolbert wrote in an August 17 research note that Fortress Biotech Inc.'s (FBIO:NASDAQ) commercially marketed dermatology products aided in delivering a positive revenue surprise in Q2/21.
The report indicated that during Q2/21, Fortress Biotech reported product revenues of $15 million, compared to $11.5 million in Q1/21. Dawson James commented that the Q2/21 revenue totals beat its estimates of $14 million and added that the company's new dermatology products are highly complementary to its business and offer potential for further growth.
The analyst stated that "Fortress announced encouraging MB-107 and MB-207 clinical updates from its investigator-IND X-linked severe combined immunodeficiency (XSCID) trials." The company is partnering with Mustang Bio Inc. (NASDAQ: MBIO) to develop and evaluate the safety and efficacy of these candidates in its investigator-IND X-linked severe combined immunodeficiency (XSCID) clinical studies.
Analyst Kolbert explained that in January 2021, "the FDA removed a CMC hold on the MB-107 Phase 2 clinical trial Investigational New Drug application after reviewing a comprehensive CMC package." Kolbert noted that with the hold removed, Fortress now plans to enroll the first patient in this multicenter trial in Q3/21 and expects to receive the first top-line data in early 2022. In addition, Kolbert mentioned that Fortress expects to file an IND in H2/21 for a pivotal Phase 2 trial of MB-207.
The report listed that the company is also partnering with Mustang in a Phase 1/2 study of MB-106, which was described as "a CD20-targeted CAR T for relapsed or refractory B-cell non-Hodgkin lymphomas (B-NHL) and chronic lymphocytic leukemia (CLL)."
Another candidate in the Fortress pipeline is an anti-PD-L1 antibody called cosibelimab. The firm is partnering with Checkpoint Therapeutics (CKPT:OTC) and is evaluating the potential use for cosibelimab in treatment of metastatic cutaneous squamous cell carcinoma.
Other candidates in Fortress's drug pipeline include olafertinib, "a light chain fibril-reactive monoclonal antibody for AL Amyloidosis," CUTX-101, copper histidinate for Menkes disease, and dotinurad which is a urate transporter (URAT1) inhibitor for treating gout and perhaps other hyperuricemic indications including heart failure and chronic kidney disease.
Dawson James advised that it has a "Buy" rating for Fortress Biotech with a 12-month price target of $24.00. The company's shares trade on the NASDAQ Exchange under the symbol FBIO and opened for trading on August 18, 2021 at $3.06/share.
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Disclosures for Dawson James Securities, Fortress Biotech Inc., August 17, 2021
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