Global pharmaceutical company Bristol Myers Squibb (NYSE: BMY) announced that it has received a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency (EMA) for Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy.
Following the news, shares of this healthcare stock rose 1.6% on Friday to close at $64.91.
The therapy is designed to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B). These patients include individuals who had undergone two or more lines of systemic therapy.
Supporting Data
The CHMP’s positive opinion is based on results from TRANSCEND NHL 001, the largest pivotal trial of patients with R/R LBCL after a minimum of two prior therapies, and additional data from the TRANSCEND WORLD study. The studies were designed to evaluate patients with R/R DLBCL, PMBCL, and FL3B. These individuals included patients with a broad range of histologies and high-risk disease, and patients who received Breyanzi in the inpatient and outpatient setting.
Expected Approvals
The European Commission (EC), which approves medicines for the European Union (EU), will now review the CHMP recommendation and is expected to announce the final decision within 67 days. Consequently, the decision will be applicable to all European Union member states, along with Iceland, Norway, and Liechtenstein.
Official Comments
SVP of Cellular Therapy Development at Bristol Myers Squibb, Anne Kerber, said, “This positive CHMP opinion is an important milestone that recognizes Breyanzi as a differentiated cell therapy with the potential to address unmet needs for patients in the European Union with aggressive lymphomas who have limited treatment options.”
“We look forward to the European Commission’s decision as we continue to accelerate our research in cell therapy to develop new treatment options for patients living with difficult-to-treat blood cancers,” Kerber added.
Wall Street’s Take
Recently, William Blair analyst Tim Lugo reiterated a Buy rating on the stock.
The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on an even split between the Buys and the Holds. The average Bristol Myers Squibb price target of $65.80 implies 1.37% upside potential. Shares have gained 7.7% over the past year.
Risk Analysis
According to the new TipRanks Risk Factors tool, Bristol Myers Squibb stock is at risk mainly from three factors: Finance and Corporate, Tech and Innovation, and Legal and Regulatory, which contribute 26%, 22%, and 19%, respectively, to the total 27 risks identified for the stock.
Given the low-risk profile and balanced pipeline of the company, investors might consider adding this stock to their basket. Additionally, BMY stock is expected to benefit from the positive news, boosting investors’ optimism on the stock.
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