In our 2021 Top Picks report, Jay Silverman — a leading biotech sector analyst and contributing editor to The Medical Technology Stock Letter — chose Celldex Therapeutics (CLDX), which rose 100% last year. He again selects the stock as a Top Pick for 2022.
Based upon its novel mast cell monoclonal antibody CDX-0159, Celldex is a favorite biotech stock pick for 2022. With exceptional Phase I/II data in chronic inducible urticaria (CindU or hives) — a 100% response rate and a clean safety profile, Celldex will deliver additional key clinical results from that study beginning in Q1:22 and another key trial in H1:22/early summer in chronic spontaneous urticaria (CSU).
An increasing number of studies are proving that mast cells are the dominant player in a variety of allergic and inflammatory conditions, including truly blockbuster conditions like asthma, allergies, arthritis. In addition to urticaria trials, which are delivered intravenously — studies are underway with a subcutaneous (SC) version that would lead to even wider at-home use. A SC pilot study is due in early 2022 as well.
Celldex also has an R&D pipeline based on humanized antibody technology (huMab) developed at Medarex, which was acquired by Bristol-Myers Squibb (BMY) in 2009, and subsequently developed Ovdipo and Yervoy for metastatic melanoma. As a wholly owned compound, Celldex is an ideal takeover candidate as several drugs are the market are being developed for urticaria but none with the mechanism and data as impressive at CDX-0159.
With the enormous potential of various mast cell blockbuster conditions, in our view, CDX-0159 has the potential to one day compete with or exceed the sales of Dupixent ($4 billion in 2020), a treatment from Sanofi (SNY) and Regeneron (REGN). CLDX is a “buy” under $55 with a target price of $85.