We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
On May 19, we issued an updated research report on Boulder, CO based Clovis Oncology, Inc. . Clovis is a biopharmaceutical company focused on the development and commercialization of treatments targeting specific subsets of cancer population.
So far this year, Clovis’ share price has been trading above the Zacks categorized Medical-Biomed/Genetics industry. The stock gained 17.6% compared with an increase of 0.4% for the broader industry.
Clovis reported results for first-quarter of 2017 earlier this month. The company’s loss of $1.33 per share in the first quarter was narrower on a year-over-year basis. Moreover, the company’s sales, entirely from Rubraca, were approximately $7.05 million in the quarter. In the year-ago quarter, Clovis did not generate any revenues.
We remind investors that Clovis received accelerated approval from the FDA in Dec 2016 for its PARP inhibitor, Rubraca (rucaparib) for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. At the earnings conference call, the company said that over 300 different healthcare practitioners had prescribed Rubraca in the quarter with over 350 new patients starting therapy. The numbers suggest good uptake of the drug.
The drug is also under review in the EU for a comparable ovarian cancer indication. Meanwhile, Clovis is looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers, among others, either as monotherapy or in combination with other agents.
In order to convert the accelerated approval to a continued approval, Clovis is required to run confirmatory studies. Clovis has completed enrollment in a pivotal maintenance confirmatory study - ARIEL3 - on Rubraca. Data is expected to be available in mid-2017, which we consider a key catalyst for the stock in the near term. If the data are positive, Clovis intends to submit a supplemental new drug application (sNDA) for a second line or later maintenance indication for advanced ovarion cancel patient. The ARIEL4 phase III treatment confirmatory study evaluating Rubraca versus chemotherapy is open for enrolment.
Also, as a post-marketing regulatory commitment related to the approval of Rubraca, Clovis announced an agreement with Myriad Genetics to use the latter’s FDA approved BRACAnalysis CDx germline companion diagnostic test to identify eligible patients for treatment with Rubraca. Meanwhile, several clinical studies were initiated in early 2017 in prostate cancer and a Tecentriq- Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding AG (RHHBY - Free Report) .
The estimate revision trend for second quarter remains favorable with four estimates moving up and one revision in the opposite direction over the past one month. Loss estimates have also narrowed 9.5% to $1.24 per share in this period. However, we are concerned as Clovis is heavily dependent on Rubraca for growth as it is the only approved product in the portfolio.
While the ovarian cancer market provides immense commercial potential, we note that Rubraca will face intense competition from the currently marketed AstraZeneca plc’s (AZN - Free Report) Lynpraza and Tesaro, Inc.’s niraparib. Meanwhile, the oncology market is attracting a lot of attention with several companies inking deals and working on bringing their candidates to this high-revenue potential market.
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
Image: Bigstock
Clovis' (CLVS) PARP Inhibtor Shows Promise, Risks Remain
On May 19, we issued an updated research report on Boulder, CO based Clovis Oncology, Inc. . Clovis is a biopharmaceutical company focused on the development and commercialization of treatments targeting specific subsets of cancer population.
So far this year, Clovis’ share price has been trading above the Zacks categorized Medical-Biomed/Genetics industry. The stock gained 17.6% compared with an increase of 0.4% for the broader industry.
Clovis reported results for first-quarter of 2017 earlier this month. The company’s loss of $1.33 per share in the first quarter was narrower on a year-over-year basis. Moreover, the company’s sales, entirely from Rubraca, were approximately $7.05 million in the quarter. In the year-ago quarter, Clovis did not generate any revenues.
We remind investors that Clovis received accelerated approval from the FDA in Dec 2016 for its PARP inhibitor, Rubraca (rucaparib) for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. At the earnings conference call, the company said that over 300 different healthcare practitioners had prescribed Rubraca in the quarter with over 350 new patients starting therapy. The numbers suggest good uptake of the drug.
The drug is also under review in the EU for a comparable ovarian cancer indication. Meanwhile, Clovis is looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers, among others, either as monotherapy or in combination with other agents.
In order to convert the accelerated approval to a continued approval, Clovis is required to run confirmatory studies. Clovis has completed enrollment in a pivotal maintenance confirmatory study - ARIEL3 - on Rubraca. Data is expected to be available in mid-2017, which we consider a key catalyst for the stock in the near term. If the data are positive, Clovis intends to submit a supplemental new drug application (sNDA) for a second line or later maintenance indication for advanced ovarion cancel patient. The ARIEL4 phase III treatment confirmatory study evaluating Rubraca versus chemotherapy is open for enrolment.
Also, as a post-marketing regulatory commitment related to the approval of Rubraca, Clovis announced an agreement with Myriad Genetics to use the latter’s FDA approved BRACAnalysis CDx germline companion diagnostic test to identify eligible patients for treatment with Rubraca. Meanwhile, several clinical studies were initiated in early 2017 in prostate cancer and a Tecentriq- Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding AG (RHHBY - Free Report) .
The estimate revision trend for second quarter remains favorable with four estimates moving up and one revision in the opposite direction over the past one month. Loss estimates have also narrowed 9.5% to $1.24 per share in this period. However, we are concerned as Clovis is heavily dependent on Rubraca for growth as it is the only approved product in the portfolio.
While the ovarian cancer market provides immense commercial potential, we note that Rubraca will face intense competition from the currently marketed AstraZeneca plc’s (AZN - Free Report) Lynpraza and Tesaro, Inc.’s niraparib. Meanwhile, the oncology market is attracting a lot of attention with several companies inking deals and working on bringing their candidates to this high-revenue potential market.
Clovis Oncology, Inc. Price and EPS Surprise
Clovis Oncology, Inc. Price and EPS Surprise | Clovis Oncology, Inc. Quote
Clovis has a Zacks Rank #3 (Hold).
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>