TG Therapeutics And Samsung Biologics Expand Ublituximab Manufacturing


Commercial-stage biopharmaceutical company TG Therapeutics and Samsung Biologics are expanding a large-scale manufacturing contract for the former’s ublituximab, an investigational monoclonal antibody.

TG Therapeutics (TGTX) has submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval for the combination of ublituximab and umbralisib in treating patients with chronic lymphocytic leukemia (CLL).

Furthermore, TG Therapeutics is also in the process of preparing a BLA for ublituximab for the treatment of relapsing forms of multiple sclerosis (RMS).

TG Therapeutics Executive Chairman and CEO Michael S. Weiss said, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications.”

Weiss added, “With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab.” (See TG Therapeutics stock analysis on TipRanks)

On April 19, H. C. Wainwright analyst Edward White reiterated a Buy rating on the stock and increased the price target to $89 (110% upside potential) from $79.

White remains confident that the BLA submission for ublituximab expected in 3Q 2021 will be a success based on Phase 3 ULTIMATE I and II trials. He expects the drug to “take market share due to its more convenient infusion time than approved anti-CD20 treatments.”

Furthermore, White estimates ublituximab sales at $53 million in 2022 with eventual growth to $1.1 billion by 2028.

Consensus on the Street is that TG Therapeutics is a Strong Buy based on 3 Buys and 1 Hold. The average analyst price target of $76 implies upside potential of 79.2%. Shares have gained about 239% over the past year.

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