Bristol Myers Squibb Gets EC Approval for Zeposia


Bristol Myers Squibb (BMY) announced that it has received a Marketing Authorization from the European Commission (EC) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). These patients include individuals who have had an inadequate response, lost response, or have been intolerant to either conventional therapy or a biologic agent.

Zeposia is the first-of-its-kind oral sphingosine 1-phosphate (S1P) receptor modulator for UC, representing an innovative way of treating this disease.

The regulator’s approval followed the data from True North, a pivotal Phase 3 trial, which is designed to evaluate Zeposia as an induction and maintenance therapy versus placebo. Results have demonstrated that Zeposia has significant, durable efficacy in patients with moderate to severe UC across clinical, endoscopic and mucosal healing endpoints, with no new safety signals.

Official Comments

The Senior VP of Immunology and Fibrosis Development at Bristol Myers Squibb, Jonathan Sadeh, said, “With today’s European Commission approval of Zeposia for ulcerative colitis, patients and physicians now have a once-daily oral treatment option to help address this debilitating disease, with a demonstrated efficacy and safety profile and a different mechanism of action than other available therapies.” (See Bristol Myers Squibb stock charts on TipRanks)

Other Approvals

In May 2021, Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active UC, and for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.

Additionally, in May 2020, the EC approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).

Wall Street’s Take

On November 18, BMO Capital analyst Evan Seigerman initiated coverage of the stock with a Buy rating and a price target of $72 (25.33% upside potential).

In a research note to investors, Seigerman said that the strong fundamentals of the company are not fully reflected in the current valuation as well the margin expansion potential.

The analyst considers shares of the company as favorable compared to its U.S. major pharma and large-cap biotechnology peers.

The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 6 Buys and 3 Holds. The average Bristol Myers Squibb price target of $73.86 implies 28.56% upside potential. Shares have lost 9.1% over the past year.

Smart Score

According to the TipRanks’ Smart Score rating system, Bristol Myers Squibb gets a 6 out of 10, which indicates that the stock is likely to perform in line with market averages. (See Top Smart Score Stocks on TipRanks)

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