How Clovis Scored Big on a Milestone FDA Approval

Health and Healthcare

Published: August 23, 2016 4:08 pm

Last Updated: January 13, 2020 4:19 am

Clovis Oncology, Inc. (NASDAQ: CLVS) is watching its shares climb late Tuesday after the company announced a key U.S. Food and Drug Administration (FDA) approval. Note that this is the first of a few regulatory steps and if Clovis continues to perform in this manner we could effectively see a huge turnaround in the stock.

Ultimately what happened was the FDA has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017.

As recently as late June 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015.

Currently management believes that there is a tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer.

Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the Principal Investigators in the ARIEL clinical trial program, commented on the announcement:

Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients.

Excluding Tuesday’s move, Clovis has underperformed the broad markets with the stock down nearly 50% year to date. Over the past 52-weeks the stock is actually down about 75%.

Shares of Clovis were last trading up nearly 30% at $23.33, with a consensus analyst price target of $18.44 and a 52-week trading range of $11.57 to $116.75.

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