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Bristol-Myers's (BMY) Opdivo Under Priority Review by FDA
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Bristol-Myers Squibb Company (BMY - Free Report) announced that its supplemental biologics license application (sBLA) for immuno-oncology drug Opdivo has been accepted for priority review by the FDA. The company is looking to expand Opdivo’s label to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in patients who have progressed on or after platinum-containing therapy.
With the FDA granting priority review status, a response should be out by Mar 2, 2017. We remind investors that Opdivo was granted Breakthrough Therapy status in the U.S. for mUC in Jun 2016.
The regulatory application included data from a single-arm phase II study – CheckMate -275 – on Opdivo.
Notably, Opdivo was accepted for review in the EU last month for the treatment of locally advanced unresectable or mUC in adults after a failure of prior platinum-containing therapy.
Earlier this month, Bristol-Myers presented data from the CheckMate -275 study at European Society for Medical Oncology Congress. The data showed that Opdivo had a confirmed objective response rate, the primary endpoint, of 19.6% in platinum-refractory patients with mUC.
Per the company’s press release, bladder cancer is the ninth most commonly diagnosed cancer in the world, accounting for an estimated 430,000 new cases per year resulting in 165,000 deaths annually. UC is the most common type of bladder cancer, which accounts for roughly 90% of the cases.
We note that Opdivo is already approved in both the U.S. and the EU for various cancer indications. Bristol-Myers is working on expanding the drug’s label even further. Opdivo is currently under priority review in the U.S. for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. A response from the FDA is expected by Nov 11. The drug is also under review in the EU for the same indication.
Opdivo had generated worldwide sales of $1.5 billion in the first half of 2016. Label expansion into additional indications would give the product access to a higher patient population and further increase the commercial potential of the drug.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to a gain of 3 cents for 2017 over the last 60 days. The company has posted positive earnings surprises twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 105% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 to $1.79 for 2017 over the last 60 days.
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Bristol-Myers's (BMY) Opdivo Under Priority Review by FDA
Bristol-Myers Squibb Company (BMY - Free Report) announced that its supplemental biologics license application (sBLA) for immuno-oncology drug Opdivo has been accepted for priority review by the FDA. The company is looking to expand Opdivo’s label to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in patients who have progressed on or after platinum-containing therapy.
With the FDA granting priority review status, a response should be out by Mar 2, 2017. We remind investors that Opdivo was granted Breakthrough Therapy status in the U.S. for mUC in Jun 2016.
The regulatory application included data from a single-arm phase II study – CheckMate -275 – on Opdivo.
BRISTOL-MYERS Price
BRISTOL-MYERS Price | BRISTOL-MYERS Quote
Notably, Opdivo was accepted for review in the EU last month for the treatment of locally advanced unresectable or mUC in adults after a failure of prior platinum-containing therapy.
Earlier this month, Bristol-Myers presented data from the CheckMate -275 study at European Society for Medical Oncology Congress. The data showed that Opdivo had a confirmed objective response rate, the primary endpoint, of 19.6% in platinum-refractory patients with mUC.
Per the company’s press release, bladder cancer is the ninth most commonly diagnosed cancer in the world, accounting for an estimated 430,000 new cases per year resulting in 165,000 deaths annually. UC is the most common type of bladder cancer, which accounts for roughly 90% of the cases.
We note that Opdivo is already approved in both the U.S. and the EU for various cancer indications. Bristol-Myers is working on expanding the drug’s label even further. Opdivo is currently under priority review in the U.S. for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. A response from the FDA is expected by Nov 11. The drug is also under review in the EU for the same indication.
Opdivo had generated worldwide sales of $1.5 billion in the first half of 2016. Label expansion into additional indications would give the product access to a higher patient population and further increase the commercial potential of the drug.
Zacks Rank & Key Picks
Bristol-Myers currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Axovant Sciences Ltd. (AXON - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to a gain of 3 cents for 2017 over the last 60 days. The company has posted positive earnings surprises twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 105% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 to $1.79 for 2017 over the last 60 days.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>