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Clovis' Rucaparib Not to Face FDA Advisory Panel, Stock Up
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Clovis Oncology, Inc.’s shares were up 15% after the company revealed in an 8-K filing that the FDA was not planning to not hold an advisory committee meeting to discuss the company’s new drug application (NDA) for its experimental ovarian cancer treatment, rucaparib.
We note that Clovis’ shares have been on the rise since late last month, when the FDA accepted the company’s NDA for rucaparib for accelerated approval and granted priority review for the candidate. A response from the FDA is expected by Feb 23, 2017.
Clovis is looking to get rucaparib approved for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors including both germline and somatic BRCA mutations (as detected by an FDA-approved test), as well as patients who have been treated with two or more chemotherapies.
We note that the FDA usually schedules a meeting with the advisory committees, which include a panel of outside experts who provide independent advice on the approval of a candidate. While the FDA is not bound to follow the recommendation of the advisory panels, it usually takes the same into consideration.
Considering Clovis’ history with the FDA, the latest development on the regulatory front raises optimism. We remind investors that Clovis suffered a huge blow (Apr 2016) when the FDA’s advisory panel asked the company for additional data on its lung cancer treatment, rociletinib and recommended the FDA to wait for the same before coming to a decision. Subsequently, the FDA had issued a complete response letter for rociletinib.
If all goes well on the regulatory front, FDA approval of rucaparib would be a huge positive for the company, given immense commercial potential and demand for PARP inhibitors. Rucaparib is an oral, small-molecule inhibitor of PARP1, PARP2 and PARP3.
As per the American Cancer Society, ovarian cancer ranks fifth in cancer-related deaths and causes more deaths than any other cancer of the female reproductive system. It is estimated that more than 22,000 new cases of ovarian cancer will be diagnosed in the U.S. in 2016. There is huge unmet need for new treatment options, given that one in four women with ovarian cancer have a germline or somatic BRCA mutation.
Meanwhile, the EU regulatory application for the candidate for a comparable ovarian cancer indication will be submitted in the fourth quarter of 2016. In addition to the ARIEL program on rucaparib, which is currently underway for ovarian cancer, Clovis is exploring rucaparib in other solid tumor types with BRCA and HRD populations, including prostate, breast and gastroesophageal cancers.
With no approved product in Clovis' portfolio at the moment and rucaparib being the company’s lead pipeline candidate, investor focus is expected to remain on the approval status of the candidate.
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Clovis' Rucaparib Not to Face FDA Advisory Panel, Stock Up
Clovis Oncology, Inc.’s shares were up 15% after the company revealed in an 8-K filing that the FDA was not planning to not hold an advisory committee meeting to discuss the company’s new drug application (NDA) for its experimental ovarian cancer treatment, rucaparib.
We note that Clovis’ shares have been on the rise since late last month, when the FDA accepted the company’s NDA for rucaparib for accelerated approval and granted priority review for the candidate. A response from the FDA is expected by Feb 23, 2017.
Clovis is looking to get rucaparib approved for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors including both germline and somatic BRCA mutations (as detected by an FDA-approved test), as well as patients who have been treated with two or more chemotherapies.
We note that the FDA usually schedules a meeting with the advisory committees, which include a panel of outside experts who provide independent advice on the approval of a candidate. While the FDA is not bound to follow the recommendation of the advisory panels, it usually takes the same into consideration.
Considering Clovis’ history with the FDA, the latest development on the regulatory front raises optimism. We remind investors that Clovis suffered a huge blow (Apr 2016) when the FDA’s advisory panel asked the company for additional data on its lung cancer treatment, rociletinib and recommended the FDA to wait for the same before coming to a decision. Subsequently, the FDA had issued a complete response letter for rociletinib.
CLOVIS ONCOLOGY Price
CLOVIS ONCOLOGY Price | CLOVIS ONCOLOGY Quote
If all goes well on the regulatory front, FDA approval of rucaparib would be a huge positive for the company, given immense commercial potential and demand for PARP inhibitors. Rucaparib is an oral, small-molecule inhibitor of PARP1, PARP2 and PARP3.
As per the American Cancer Society, ovarian cancer ranks fifth in cancer-related deaths and causes more deaths than any other cancer of the female reproductive system. It is estimated that more than 22,000 new cases of ovarian cancer will be diagnosed in the U.S. in 2016. There is huge unmet need for new treatment options, given that one in four women with ovarian cancer have a germline or somatic BRCA mutation.
Meanwhile, the EU regulatory application for the candidate for a comparable ovarian cancer indication will be submitted in the fourth quarter of 2016. In addition to the ARIEL program on rucaparib, which is currently underway for ovarian cancer, Clovis is exploring rucaparib in other solid tumor types with BRCA and HRD populations, including prostate, breast and gastroesophageal cancers.
With no approved product in Clovis' portfolio at the moment and rucaparib being the company’s lead pipeline candidate, investor focus is expected to remain on the approval status of the candidate.
Clovis currently has a Zacks Rank #2 (Buy). Other favorably ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Geron Corporation (GERN - Free Report) and Anika Therapeutics Inc. (ANIK - 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.
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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>>