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Clovis Scales 52-Week High on Early FDA Nod for Rubraca
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Clovis Oncology, Inc.’s shares got a boost from an accelerated approval for its advanced ovarian cancer drug, Rubraca (rucaparib), in the U.S. Notably, the approval came more than two months ahead of schedule. The FDA was expected to render a final decision on Rubraca by Feb 23, 2017.
Shares of the company touched a new 52-week high of $46.97 on Dec 19, before eventually closing at $40.48. Overall, the stock climbed 8.8% on the news. Clovis’ year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry, having surged 15.7% during this period, while the industry lost 25.1%.
Rubraca has been approved as monotherapy for patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic test.
This makes Rubraca the first and only PARP inhibitor to be approved by the FDA for this indication.
Note that Rubraca was approved under the FDA’s accelerated approval program based on the objective response rate and duration of response data from two multi-center, single-arm, open-label studies, Study 10 and ARIEL2. These programs allow for fast approval of drugs that are intended to treat serious conditions and satisfy an unmet medical need. Continued approval in this indication will depend upon the verification and description of clinical benefit in confirmatory studies.
Clovis continues to study Rubraca in patients with advanced ovarian cancer who have BRCA gene mutations as well as other types of ovarian cancer. While the ARIEL3 maintenance confirmatory study has completed enrollment, the ARIEL4 treatment confirmatory study is enrolling patients at present.
The FDA has concurrently approved Foundation Medicine, Inc.’s FoundationFocus CDxBRCA companion diagnostic to help identify patients eligible for treatment with Rubraca. It is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations (germline and/or somatic) in ovarian cancer patients.
We note that Clovis had collaborated with Foundation Medicine to co-develop the companion diagnostic test.
We are encouraged by the FDA approval for Rubraca. Note that Rubraca not only will be the first approved product in Clovis’ portfolio, but it also has bright prospects given the immense commercial potential of the target market and the tremendous demand for PARP inhibitors.
According to the National Cancer Institute, an estimated 22,280 women will be diagnosed with ovarian cancer in 2016, of which around 14,240 will die of the disease. Approximately 15–20% of patients with ovarian cancer have a BRCA gene mutation.
We note that AstraZeneca plc’s (AZN - Free Report) PARP inhibitor, Lynparza, is also approved for the advanced ovarian cancer indication.
Meanwhile, Clovis is looking to get Rubraca approved in the EU. The company filed a regulatory application for Rubraca for a comparable ovarian cancer treatment indication in the ongoing quarter.
Clovis is also working on developing Rubraca for other types of cancer including prostate, breast and gastroesophageal cancers.
We expect investor focus to remain on the commercialization and sales uptake of Rubraca.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
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Clovis Scales 52-Week High on Early FDA Nod for Rubraca
Clovis Oncology, Inc.’s shares got a boost from an accelerated approval for its advanced ovarian cancer drug, Rubraca (rucaparib), in the U.S. Notably, the approval came more than two months ahead of schedule. The FDA was expected to render a final decision on Rubraca by Feb 23, 2017.
Shares of the company touched a new 52-week high of $46.97 on Dec 19, before eventually closing at $40.48. Overall, the stock climbed 8.8% on the news. Clovis’ year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry, having surged 15.7% during this period, while the industry lost 25.1%.
Rubraca has been approved as monotherapy for patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic test.
This makes Rubraca the first and only PARP inhibitor to be approved by the FDA for this indication.
Note that Rubraca was approved under the FDA’s accelerated approval program based on the objective response rate and duration of response data from two multi-center, single-arm, open-label studies, Study 10 and ARIEL2. These programs allow for fast approval of drugs that are intended to treat serious conditions and satisfy an unmet medical need. Continued approval in this indication will depend upon the verification and description of clinical benefit in confirmatory studies.
Clovis continues to study Rubraca in patients with advanced ovarian cancer who have BRCA gene mutations as well as other types of ovarian cancer. While the ARIEL3 maintenance confirmatory study has completed enrollment, the ARIEL4 treatment confirmatory study is enrolling patients at present.
The FDA has concurrently approved Foundation Medicine, Inc.’s FoundationFocus CDxBRCA companion diagnostic to help identify patients eligible for treatment with Rubraca. It is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations (germline and/or somatic) in ovarian cancer patients.
We note that Clovis had collaborated with Foundation Medicine to co-develop the companion diagnostic test.
We are encouraged by the FDA approval for Rubraca. Note that Rubraca not only will be the first approved product in Clovis’ portfolio, but it also has bright prospects given the immense commercial potential of the target market and the tremendous demand for PARP inhibitors.
According to the National Cancer Institute, an estimated 22,280 women will be diagnosed with ovarian cancer in 2016, of which around 14,240 will die of the disease. Approximately 15–20% of patients with ovarian cancer have a BRCA gene mutation.
We note that AstraZeneca plc’s (AZN - Free Report) PARP inhibitor, Lynparza, is also approved for the advanced ovarian cancer indication.
Meanwhile, Clovis is looking to get Rubraca approved in the EU. The company filed a regulatory application for Rubraca for a comparable ovarian cancer treatment indication in the ongoing quarter.
Clovis is also working on developing Rubraca for other types of cancer including prostate, breast and gastroesophageal cancers.
We expect investor focus to remain on the commercialization and sales uptake of Rubraca.
CLOVIS ONCOLOGY Price and Consensus
CLOVIS ONCOLOGY Price and Consensus | CLOVIS ONCOLOGY Quote
Zacks Rank & a Key Pick
Clovis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in this industry is MannKind Corporation (MNKD - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>