San Diego, CA -- (SBWire) -- 01/13/2016 --A shareholder of Clovis Oncology Inc (NASDAQ:CLVS), filed a lawsuit in the U.S. District Court for the District of Colorado over alleged violations of Federal Securities Laws by Clovis Oncology Inc.
Investors who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) have certain options and for certain investors are short and strict deadlines running. Deadline: January 19, 2015. NASDAQ:CLVS investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
The plaintiff claims that between October 31, 2013 and November 15, 2015 Defendants made false and/or misleading statements and/or failed to disclose: (1) that the New Drug Application ("NDA") that Clovis submitted to the FDA for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates; (2) that Clovis' Breakthrough Therapy designation submission contained immature data set based primarily on unconfirmed responses; (3) that Clovis presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses; (4) that as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected; (5) that, as a result of the foregoing, Clovis' NDA was likely to be delayed and/or rejected by the FDA; and (6) that, as a result of the foregoing, the Defendants' statements about Clovis' business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.
Shares of Clovis Oncology Inc (NASDAQ:CLVS) grew from $36.80 per share in August 2014 to as high as $114.64 per share in September 2015.
On November 16, 2015, Clovis Oncology Inc (NASDAQ:CLVS) announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib.
Clovis Oncology Inc said that in the Mid-Cycle Communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses and that the New Drug Application (NDA) submitted by Clovis to the FDA contained immature data sets based on both unconfirmed response rates and confirmed response rates. Shares of Clovis Oncology Inc (NASDAQ:CLVS) declined to as low as $26.05 per share on November 16, 2015, respectively $25.33 per share on January 11, 2016.
On January 12, 2016, NASDAQ:CLVS shares closed at $27.45 per share.
Those who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
Clovis Oncology Inc (NASDAQ:CLVS) Shareholder Alert: Lawsuit Alleges False and Misleading Statements
A lawsuit was filed on behalf of investors in Clovis Oncology Inc (NASDAQ:CLVS) shares over alleged securities laws violations and NASDAQ:CLVS investors should contact the Shareholders Foundation.