Clovis reports a hiccup in its rociletinib trial data; regulatory approval

Clovis revealed that the US Food and Drugs Administration (FDA) had requested additional information regarding the efficacy analysis of the group’s Rociletinib drug candidate.

“We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer”, Clovis president and CEO Patrick J. Mahaffy said in a statement.

“In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses”, Clovis added. The most frequent reasons for the lack of confirmation in a subsequent scan were progression and failure to show tumor shrinkage greater than 30%. The FDA said it would only consider the efficacy of confirmed responses, and the original new drug application included a few unconfirmed response rates.

Clovis said the additional study data meant that the FDA could delay its ruling on rociletinib beyond the scheduled date of March 30. The company has a 50 day moving average of $96.59 and a 200 day moving average of $89.11. CLVS has a 1-year high of $116.75 and a 1-year low of $45.50.

Now the company Insiders own 25.9% of Clovis Oncology, Inc. shares according to the proxy statements.

Near the closing bell on Wall Street, Clovis’ stock (NYSE: CLVS) was trading at $31.31, down more than 68 percent from Monday’s opening price but a slight recovery from a 72 percent decline just after noon.

In a recent survey, 1 analysts were expecting an average of $-1.51 earnings per share for Clovis Oncology Incorporated, for the 4 quarter of the fiscal year ending in 2016.

CLVS and Clovis Oncology Incorporated stock and share performance over the last 6 months. Three research analysts have rated the stock with a hold rating, three have issued a buy rating and one has issued a strong buy rating to the company’s stock.

Clovis Oncology Inc is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional global markets.