Shares of Clovis Oncology Inc (NASDAQ:CLVS) ended Wednesday session in green amid volatile trading. The shares closed up +2.52 points or 7.25% at $37.28 with 5.10 million shares getting traded. Post opening the session at $34.61, the shares hit an intraday low of $34.02 and an intraday high of $38.46 and the price vacillated in this range throughout the day. The company has a market cap of $1.41 billion and the numbers of outstanding shares have been calculated to be 38.50 million shares.
Clovis Oncology Inc (CLVS) announced that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. In late June 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015.
“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”
Shares of Eli Lilly and Co (NYSE:LLY) ended Wednesday session in green amid volatile trading. The shares closed up +0.64 points or 0.79% at $81.75 with 3.56 million shares getting traded. Post opening the session at $81.35, the shares hit an intraday low of $81.23 and an intraday high of $82.09 and the price vacillated in this range throughout the day. The company has a market cap of $90.36 billion and the numbers of outstanding shares have been calculated to be 1.10 billion shares.
Eli Lilly and Co (LLY) will present data from several studies which further reinforce the advancement of its diverse clinical cancer portfolio during the European Society of Medical Oncology’s (ESMO) 2016 Congress in Copenhagen, October 7-11. Presentations include new data on abemaciclib, a CDK 4 and CDK 6 inhibitor, and olaratumab, a PDGFRα blocking antibody that recently received a positive CHMP opinion, as well as data on: pemetrexed, a multi-targeted antifolate; ramucirumab, a VEGF Receptor 2 antagonist; necitumumab, an EGFR blocking antibody; and prexasertib, a cell cycle checkpoint kinases 1 and 2 inhibitor. Of these presentations, four are featured in late-breaking abstracts (two on abemaciclib, and one each on pemetrexed and ramucirumab).
The presentations on pemetrexed, ramucirumab and necitumumab include data from a few of Lilly’s immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in trials that are evaluating these molecules in combination with Merck’s pembrolizumab. Notably, the first results from KEYNOTE-021G – which studied pembrolizumab in combination with pemetrexed-plus-carboplatin compared to pemetrexed-plus-carboplatin alone for the first-line treatment of patients with advanced nonsquamous non-small cell lung cancer regardless of PD-L1 expression – will be featured in the Presidential Symposium on October 9.