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Bristol Myers' (BMY) Opdualag Wins FDA Nod for Melanoma

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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo (nivolumab) and relatlimab (novel LAG-3-blocking antibody) administered as a single intravenous infusion for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma (a kind of skin cancer).

The drug is approved under the brand name Opdualag.  The approval is based on positive results from the phase II/III RELATIVITY-047 study, which compared Opdualag (n=355) to Opdivo alone (n=359).

Opdualag more than doubled median progression-free survival compared to Opdivo monotherapy.

The FDA-approved dosing for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every four weeks.

While Opdivo is approved for various immuno-oncology indications, relatlimab is the third immune checkpoint inhibitor from Bristol Myers.  The approval strengthens BMY’s growing and differentiated oncology portfolio, which also has Yervoy approved for melanoma.

On the fourth-quarter earnings call, management stated that it expects approval of three key pipeline candidates in 2022 — mavacamten, deucravacitinib and relatlimab. Each of these assets should generate at least $4 billion of revenues at the end of the decade.

In November, the FDA extended the review of the new drug application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to Apr 28, 2022.  The FDA has also accepted the NDA, and the EMA has validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a target action date of Sep 10, 2022, for the same.

Shares of Bristol Myers have rallied 13.9% year to date against the industry’s decline of 12.7%.


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Key drugs, namely Revlimid and Eliquis, maintain momentum for Bristol Myers. The approval of new drugs adds a revenue stream, which should boost growth in the coming quarters. The pipeline progress is steadily impressive, and strategic collaborations will further expand the portfolio.

However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.

The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or after nephrectomy and resection of metastatic lesions. Further, label expansion of the drug will boost Merck’s top line.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the biotech sector are Vertex Pharmaceuticals (VRTX - Free Report) and Kaleido Biosciences , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 9.5% in the past year.

Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.


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