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Clovis Oncology Tumbles 20% On Rucaparib Data

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Clovis Oncology Tumbles 20% On Rucaparib Data

Shares of Clovis Oncology Inc (NASDAQ: CLVS) plunged more than 25 percent early Friday after the company disclosed its oral presentation of the primary efficacy and safety data for rucaparib from its NDA dataset at the 2016 ESMO Congress.

The company indicated that the drug candidate is under FDA's priority review for the treatment of monotherapy of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of germline and somatic BRCA mutations. The submission date for PDUFA is February 23, 2017.

Clovis Oncology's CEO and Preisdent, Patrick Mahaffy, commented, "Our NDA review is ongoing with FDA, and in addition we are actively preparing for a European submission during the fourth quarter of 2016."

The company revealed that Rucaparib is its oral, small molecule inhibitor of PARP1, PARP2 and PARP3. Currently, the NDA submission sought approval for patients with tumor BRCA mutations.

Clovis disclosed that the results demonstrated that "rucaparib may represent an important option for women with multiply relapsed BRCA-mutated ovarian cancer based on its encouraging efficacy and tolerability,"

There was a total of 377 ovarian cancer patients, who were given treatment with rucaprib 600 mg. Sixty-one percent of them experienced AE grade 3 or higher treatment-emergent.

Of the 377 ovarian cancer patients treated with a starting dose of rucaparib 600 mg, 377 experienced a treatment-emergent adverse event (AE) of any grade, and 229 (61 percent) experienced a treatment-emergent AE grade 3 or higher.

The company's statement does not provide any unfavorable data to suggest a sharp drop in the stock price.

At last check, the stock traded at $29.20, down $6.65, or 18 percent.

Posted-In: rucaparibBiotech News Health Care FDA Movers General Best of Benzinga

 

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