News

Bristol Myers Squibb BMY announced that the European Commission (EC) has approved its blockbuster immuno-oncology drug, Opdivo (nivolumab), in combination with a chemotherapy combination, cisplatin and gemcitabine, as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma (UC).

Following the approval in Europe, the Opdivo combination became the first concurrent immunotherapy-chemotherapy approved for treating adult patients with unresectable or metastatic UC in a first-line setting.

The EC’s approval was based on data from the CheckMate-901 study of the Opdivo plus cisplatin and gemcitabine combination in the above-mentioned patient population.

Per an assessment by an independent review body, treatment with the combo therapy followed by treatment with Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival and progression-free survival.

Per the company, Opdivo, in combination with cisplatin and gemcitabine, improved overall survival, reduced the risk of disease progression or death by 28 and demonstrated deep and durable responses as compared to chemotherapy alone.

Shares of Bristol Myers have plunged 21.6% year to date compared with the industry’s decline of 6.8%.

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Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the EU.

In bladder cancer, Opdivo is approved in Europe for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection

Bristol Myers is currently evaluating Opdivo in different ongoing clinical studies spread across all phases in a variety of tumor types.

Opdivo was a key contributor to top-line growth for Bristol Myers in 2023. The drug recorded $9 billion in sales, reflecting an increase of 10% year over year.

Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. KRYS, Marinus Pharmaceuticals, Inc. MRNS and Minerva Neurosciences, Inc. NERV, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 26.1%.

KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.

In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.43 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 85.9%.

MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.

In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 61%.

NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.

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