Here’s Why Clovis Oncology (CLVS) Stock Price Surged by 56.4% Today

Key points:
Clovis Oncology shares surged 56.4% on positive phase 3 clinical trial results.
The company said it intends to apply for approval from the FDA in Q2 2022.
Investors cheered the announcement, as evidenced by the rally in CLVS stock.

The Clovis Oncology (NASDAQ: CLVS) stock price surged by 56.4% after releasing positive data from its phase 3 ATHENA study evaluating Rubraca monotherapy versus a placebo (ATHENA-MONO).

Also read: Best Healthcare Stocks To Buy Right Now.

Investors cheered the results and were impressed after the company revealed plans to submit data from the phase 3 trial to the US Food & Drug Administration (FDA) as part of its supplemental New Drug Application (sNDA) in Q2 2022.

Clovis also plans to submit a Type II Variation to the EMA during Q3 2022 for Rubraca’s use as a first-line maintenance treatment for women with advanced ovarian cancer who have responded well to first-line platinum-based chemotherapy despite their biomarkers.

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Patrick J. Mahaffy, Clovis Oncology’s President and CEO, said: “The results from the ATHENA-MONO study of Rubraca in first-line maintenance treatment ovarian cancer exceeded our expectations in terms of significant improvement in PFS versus placebo in each of the primary efficacy populations, including the all-comers or intent-to-treat population,”

Adding:

“We believe that the positive results from ATHENA-MONO demonstrate that Rubraca will provide an important new treatment option for women with advanced ovarian cancer in the first-line maintenance setting, and we look forward to submitting these data to the regulatory authorities in the US and Europe during Q2 and Q3 2022, respectively.”

The phase 3 clinical trial of Rubraca, also known as Rucaparib, was conducted in two statistically independent parts, with the first part known as ATHENA-MONO, whose results were released today. The study measured Rucaparib versus the placebo.

The second part of the study was referred to as ATHENA-COMBO, a combo study that measures the effectiveness of (rucaparib+nivolumab vs rucaparib). The results of this study are expected in Q1 2023.

Rebecca S. Kristeleit, MD, PhD, lead investigator of the ATHENA trial, said: “I believe the significant improvement in PFS demonstrated in the ATHENA-MONO trial underscores the importance of first-line maintenance therapy and the benefit that rucaparib can provide to women with advanced ovarian cancer irrespective of HRD status,”

Adding:

“Ovarian cancer remains a leading cause of cancer-related death among women, which highlights the continued need for new treatment options and strategies for women with the newly-diagnosed disease. The ATHENA-MONO study demonstrates the role of rucaparib monotherapy in the first-line maintenance treatment setting for advanced ovarian cancer.”

Investors who missed out on today’s rally may get another opportunity later when Clovis Oncology stock pulls back.

*This is not investment advice. Always do your due diligence before making investment decisions.

Clovis Oncology share price.

The Clovis Oncology share price rallied 56.36% to trade at $2.58, rising from Wednesday’s closing price of $1.65.