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Bristol-Myers’ Opdivo gets FDA Nod for Every Four Week Dosing


Bristol-Myers Squibb Company BMY announced that the FDA approved Opdivo label update for flexible flat-dosing options every two weeks (240 mg) or every four weeks (480 mg) for a majority of approved indications. Opdivo is now the first and only FDA-approved PD-1 Inhibitor for every four-week dosing. Further, Opdivo also was approved for a shorter 30-minute infusion across all approved indications.

Bristol-Myers’shares have returned 15.7% over a year, outperforming the industry’s gain of 8.4%.

The new dosing schedule is available for use in patients with metastatic melanoma, either as monotherapy or monotherapy phase after combination treatment with Yervoy (ipilimumab). It will also be available for patients with previously treated metastatic non-small-cell lung cancer, advanced renal cell carcinoma following prior anti-angiogenic therapy and previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy. It is also available for the treatment of patients with classical Hodgkin lymphoma, recurrent/metastatic squamous cell carcinoma of the head and neck and hepatocellular carcinoma as well as an adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

We remind investors that Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in the world in July 2014. Notably, the drug became the first PD-1 inhibitor to be approved for a hematological malignancy — classic Hodgkin lymphoma — in both the United States (May 2016) and the EU (November 2016).

In November 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.

Opdivo continues to be launched globally on approvals and label expansions. It also received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. In fact, the Opdivo+Yervoy regimen is approved in multiple markets for the treatment of melanoma.

Opdivo, generated revenues of $1.36 billion in the fourth quarter of 2017, up 4% from the year-ago period.

Zacks Rank & Stocks to Consider

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

A few better-ranked stocks from the same space are Regeneron REGN, Ligand Pharmaceuticals LGND and Enanta Pharma ENTA. While Regeneron and Ligandsport a Zacks Rank #1 (Strong Buy), Enanta Pharma carries a Zacks Rank #2 (Buy), each. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $17.13 to $18.65 and from $20.37 to $21.56 for 2018 and 2019, respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

Ligand’s earnings per share estimates have moved up $3.54 to $4.15 from $4.75 to $5.75 for 2018 and 2019 respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 57.2% over a year.

Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares surged 181.2% over a year.

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