Shares of Clovis Oncology Inc (NASDAQ:CLVS) ended Monday session in green amid volatile trading. The shares closed up +0.85 points or 2.44% at $35.68 with 12.82 million shares getting traded. Post opening the session at $37.28, the shares hit an intraday low of $33.62 and an intraday high of $37.60 and the price vacillated in this range throughout the day. The company has a market cap of $1.55 billion and the numbers of outstanding shares have been calculated to be 38.50 million shares.
Clovis Oncology Inc (CLVS) on August 23, 2016 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.”
“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients,” said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the Principal Investigators in the ARIEL clinical trial program.
Shares of Immune Pharmaceuticals Inc (NASDAQ:IMNP) ended Monday session in red amid volatile trading. The shares closed down -0.020 points or -6.90 at $0.270 with 7.36 million shares getting traded. Post opening the session at $0.29, the shares hit an intraday low of $0.25 and an intraday high of $0.29 and the price vacillated in this range throughout the day. The company has a market cap of $25.39 million and the numbers of outstanding shares have been calculated to be 101.58 million shares.
Immune Pharmaceuticals Inc (IMNP) on Sept. 16, 2016 announced that the Board of Directors has approved to designate Maxim Pharmaceuticals Inc. (“Maxim”), one of the Company’s existing subsidiaries, as the dedicated entity to develop and commercialize, and hold the intellectual property related to, AmiKet® and other related pain and neurology assets. In addition, the Company has entered into a binding agreement with NPT (the “Binding Agreement”), a syndicate of experienced healthcare investors, pursuant to which NPT or its designees have agreed to purchase up to $20 million of the capital stock of Maxim, with an initial funding of $5 million to occur within thirty days. Previously, the Company entered into an option agreement with NPT, dated May 15, 2016, as amended on July 18, 2016. Pursuant to the Binding Agreement, immediately following the $5 million initial funding by NPT, Immune will expand the Board of Directors of Maxim, to five members which will include one NPT representative, and a newly hired Chief Executive Officer of Maxim.