Bristol-Myers Squibb Company BMY announced a collaboration agreement with clinical-stage biopharmaceutical company Apexigen, Inc.
Both the companies will collaborate for a clinical trial to evaluate Bristol-Myers Squibb’s immuno-oncology drug Opdivo in combination with Apexigen’s APX005M in patients with advanced solid tumors.
APX005M is an experimental compound, designed to activate CD40, a key immune co-stimulatory receptor essential to regulate the activation of both innate and adaptive immune responses against cancer.
Both the companies will collaborate to evaluate the safety, tolerability and preliminary efficacy of APX005M in combination with Opdivo in second-line metastatic NSCLC patients who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior I-O therapy.
We remind investors that Opdivo is approved for varied indications in both EU and the U.S. Opdivo received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2015. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 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.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data. A potential earlier-than-expected entry of Merck’s MRK Keytruda in combination with chemotherapy will further impact Opdivo sales.
While Bristol-Myers’ share price decreased 20.8% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 1.4%.
Zacks Rank & Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Heska Corp. HSKA and Retrophin, Inc. RTRX. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
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