In a still-fresh press release, Clovis Oncology (NASDAQ:CLVS) just announced that its Phase 3 trial for Rubraca, a prostate cancer treatment, achieved its primary endpoint. Moreover, Clovis plans to submit a supplemental New Drug Application (NDA) to the Food and Drug Administration (FDA) for a specific subgroup of prostate cancer patients and intends to discuss NDA submission for a broader patient population with the FDA. All in all, these developments are having a positive effect on CLVS stock today.
Clovis Oncology is a small biotechnology firm with a market capitalization of around $175 million. Yet, the company wants to make a big impact in combating prostate cancer.
To this end, Clovis is advancing a Phase 3 clinical trial for Rubraca, called TRITON3. As it turns out, Clovis Oncology discovered “significantly improved radiographic progression-free survival (rPFS) by independent radiology review (IRR)” with Rubraca “compared with the control group.” That control group was administered docetaxel, abiraterone acetate or enzalutamide.
That’s not all, though. In 2023’s first quarter, Clovis Oncology intends to submit a supplemental NDA to the FDA. This will be for the “BRCA subgroup of patients,” which relates to breast cancer potentiality. Furthermore, Clovis plans to talk with the FDA about possibly submitting an NDA for “the broader ITT” or intent-to-treat population.
What’s Happening With CLVS Stock?
CLVS stock wobbled quite a bit this morning. Specifically, it moved up as much as 4% before pulling back to a 2% daily gain. Perhaps, traders are still digesting all of the medical terminology and considering its implications.
Still, one doesn’t have to be a medical professional to appreciate the progress that Clovis Oncology is making here. Prostate cancer has already taken too many men’s lives. So, it’s great news that Rubraca met its primary endpoint in this stage of the clinical trial.
Alan H. Bryce, chair of the Division of Hematology and Medical Oncology at the Mayo Clinic, made an important point about this. “Men with this type of metastatic prostate cancer want to get their genetically targeted therapy as early as possible,” he advised.
Meanwhile, financial traders will want to know that “this trial clearly shows the value of rucaparib as a treatment for these men.” Bryce clearly sees the significance of today’s announcement from Clovis Oncology. It’s up to Wall Street to decide whether CLVS stock will, in due time, move higher on the news.
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On the date of publication, David Moadel did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
