Clovis Oncology, Inc. (NASDAQ: CLVS) is watching its shares hit a new 52-week high after the company reported a key U.S. Food and Drug Administration (FDA) approval. Essentially, the FDA approved Rubraca (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated, advanced ovarian cancer. These are also patients who have been previously treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca’s indication was approved under the FDA’s accelerated approval program, and is based on objective response rate (ORR) and duration of response results from open-label clinical trials, Study 10 and ARIEL2 Parts 1 and 2.

The continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The ARIEL3 maintenance confirmatory study has completed enrollment and the ARIEL4 treatment confirmatory study is open for enrollment. Warning and precautions include Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML).

Patrick J. Mahaffy, CEO and President of Clovis, commented:

We look forward to launching Rubraca with the support of our established U.S. commercial and medical affairs organizations and bringing this much-needed precision medicine to women with advanced ovarian cancer as quickly as possible.

After seeing this update, Janney Capital released a report updating its view on the company and raising its fair value to $38 from $34 per share:

We are increasing our full year 2017 Rubraca sales estimate to $36 million from $22 million and increasing our EPS estimate to a loss of $(0.64) from a loss of $(1.10). We are increasing our full year 2018 Rubraca sales estimate to $267 million and increasing our EPS estimate to a loss of $(3.60) from a loss of $(5.32). The two other ongoing studies, ARIEL3 (maintenance setting) and ARIEL4 (relapse after three prior lines of Pt-based therapy in a Pt-sensitive), population are key other near-term drivers for Clovis.

Excluding Monday’s move, Clovis has underperformed the broad markets with the stock up about 6% in this time.

Shares of Clovis have been trading around 11% at $41.20, with a consensus analyst price target of $34.75 and a 52-week trading range of $11.57 to $46.94.

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