Clovis Oncology (CLVS) Stock Heads Up On FDA Approval

Clovis Oncology CLVS Stock News

Clovis Oncology Inc (NASDAQ: CLVS) is heading up in the market this morning following an announcement that was made late Friday surrounding an FDA approval. Here’s what’s going on:

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CLVS Stock Gains On FDA Approval Of Rubraca

In the late-Friday press release, Clovis Oncology said that the United States Food and Drug Administration, or FDA, has approved Rubraca tablets. The treatment was approved for adults with a deleterious BRCA mutation (germline and.or somatic)-associated metastatic castration resistant prostate cancer.

Under the approval, patients with thi condition must have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy prior to being treated with Rubraca.

In the release, CLVS said that the FDA approved the drug under acclerated approval. The approval was based on the ORR and DOR data from a multi-center, single-arm clinical trial.

Due to the fact that the drug was approved under accelerated approval, continued approval is contingent upon the verification and description of clinical benefit in confirmatory trials. The confirmatory trial for the treatment will be known as TRITON3.

In a statement, Wassim Abida, M.D, Principal Investigator in the CLVS TRITON2 study, had the following to offer:

Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T. Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation. Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population.

This News Is Exciting

Ultimately, this is huge news for Clovis Oncology. First and foremost, the approval means that the company now has a treatment that it can move into commercialization, opening the door to revenue generation opportunities. However, the excitement goes well beyond that.

The truth of the matter is that the prostate cancer market is a massive one. In fact, experts expect that by the year 2025, the prostate cancer drug market will grow to be worth nearly $10 billion annually.

Of course, it would be ridiculous to expect that CLVS will take 100% of this market, but it doesn’t have to. The company has a market cap of about $745 million. Tapping into a small percent of this vast market would be a big win.

All in all, there’s very good reason for investors to be excited about CLVS stock.

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