Key Developments: Clovis Oncology Inc (CLVS.OQ)
77.36USD
1 Aug 2013
$-0.52 (-0.67%)
$77.88
$79.25
$81.75
$74.03
135,728
103,511
$86.29
$11.19
Latest Key Developments (Source: Significant Developments)
Clovis Oncology Inc Announces Exercise In Full Of Underwriters’ Option To Purchase Additional Shares Of Common Stock
Clovis Oncology Inc announced that the underwriters of its recently announced public offering of its common stock have exercised in full their option to purchase an additional 486,110 shares. The offering, including the sale of the additional shares, is expected to close on June 17, 2013, subject to customary closing conditions. Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including funding of its development programs, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. J. P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC acted as joint book-running managers for the offering, and Leerink Swann LLC acted as co-manager for the offering. Full Article
Clovis Oncology Inc Announces Upsizing and Pricing of Public Offering of Common Stock
Clovis Oncology Inc announced the pricing of an underwritten public offering of 3,333,334 shares of its common stock at $72.00 per share, before underwriting discounts and commissions. The size of the offering was upsized from $170 million to $240 million. In addition, the underwriters have a 30-day option to purchase up to an additional 486,110 shares of common stock from Clovis Oncology to cover over-allotments, if any. The offering is expected to close on June 17, 2013, subject to customary closing conditions. Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including funding of its development programs, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. J. P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers for the offering, and Leerink Swann LLC is acting as co-manager for the offering. Full Article
Clovis Oncology Inc Announces Proposed Offering of Common Stock
Clovis Oncology Inc announced that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of $170 million. Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including funding of its development programs, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. J. P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers for the offering, and Leerink Swann LLC is acting as co-manager for the offering. In addition, Clovis Oncology intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold to cover over-allotments. Full Article
Clovis Oncology Inc Announces Negative Outcome Of CO-101 In Pivotal LEAP Pancreatic Cancer Study
Clovis Oncology Inc announced the results from its LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 versus gemcitabine in metastatic pancreatic cancer. There was no difference in overall survival between the two arms in either the primary analysis of the hENT1-low patient population, or in the overall intent-to-treat population. Median survival in each arm was approximately six months with a hazard ratio of 0.99, and is entirely consistent with the survival results from other gemcitabine studies in metastatic pancreatic cancer. Toxicities were comparable between the two arms, and no differences were observed in any subgroup analyses. Key prognostic variables, including performance status and age, were balanced between the hENT1-low and -high groups. Importantly, the study also demonstrated that, contrary to the results of numerous published retrospective studies, hENT1 status had no impact on survival for patients on gemcitabine. As a consequence of these results, Clovis will suspend all development of CO-101, pending further evaluation of the LEAP data, and focus its resources on the three product candidates in its portfolio. Full Article
Clavis Pharma ASA and Clovis Oncology Inc Announce Initiation of Phase I Study of CP-4126 (CO-101) in Combination with Cisplatin in Non-small-cell Lung Cancer
Clavis Pharma ASA announced that a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC) has been initiated by its partner Clovis Oncology Inc. The first patient has been dosed in this two-part study, which is being conducted in the United States and the United Kingdom. The combination of cisplatin and gemcitabine has been shown to be an effective regimen for solid tumors including NSCLC. However, entry of gemcitabine into tumor cells has been shown to be dependent on specific membrane transporter proteins, particularly human equilibrative nucleoside transporter 1 (hENT1). As a result, patients with low tumor hENT-1 expression may respond poorly to gemcitabine-containing treatment regimes. CP-4126 is a fatty acid derivative of gemcitabine developed using Clavis Pharma's lipid vector technology (LVT), and can enter cells in the absence of hENT1. Therefore, CP-4126 may overcome hENT1-mediated resistance to gemcitabine. CP-4126 is being evaluated as a single agent in a pivotal randomized trial (LEAP) in 360 patients with metastatic pancreatic cancer. Top-line data are expected in the fourth quarter of 2012. The objectives of the study are: to determine the maximum tolerated dose of CP-4126 when combined with a fixed dose of cisplatin in patients with solid tumors, select recommended dose for dose expansion in patients with advanced (Stage IIIb/IV) NSCLC and explore clinical activity of CP-4126 in patients with Stage IIIb/IV NSCLC. Full Article
Clovis Oncology Inc and Array BioPharma, Inc. Announce Agreement To Discover Mutant KIT Inhibitor
Clovis Oncology Inc and Array BioPharma, Inc. announced an agreement for the discovery of a KIT inhibitor targeting resistance mutations for the treatment of GIST. GIST is a gastrointestinal cancer diagnosed each year in more than 12,000 patients in the US and EU and 2,500 in Japan. Currently approved therapies for GIST include the tyrosine kinase inhibitors (TKIs) Gleevec (imatinib), and Sutent (sunitinib), typically used first- and second-line respectively. Each inhibits some KIT mutations, but acquired resistance due to secondary KIT mutations occurs in the majority of GIST patients, resulting in disease progression. Full Article
Clovis Oncology Inc Announces Pricing of Public Offering
Clovis Oncology Inc announced the pricing of its underwritten public offering of 3,750,000 shares of its common stock at $20.00 per share, before underwriting discounts and commissions. In addition, the underwriters have a 30-day option to purchase up to an additional 562,500 shares of common stock from Clovis Oncology to cover over-allotments, if any. The offering is expected to close on April 10, 2012, subject to customary closing conditions. J. P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers for the offering, and Leerink Swann LLC is acting as co-manager for the offering. Full Article
Clovis Oncology Inc Announces Proposed Public Offering Of Common Stock
Clovis Oncology Inc announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of $75 million of shares of its common stock. In addition, Clovis Oncology expects to grant the underwriters the option to purchase up to $11.25 million of additional shares to cover over-allotments. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology. J. P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers for the offering, and Leerink Swann LLC is acting as co-manager for the offering. This offering shall be made only by means of a prospectus. Full Article
Clovis Oncology Inc Announces FDA Acceptance Of Investigational New Drug Application For Oral EGFR Mutant-Selective Inhibitor CO-1686
Clovis Oncology Inc announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin clinical investigation of CO-1686, a oral, targeted covalent inhibitor of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). Initial Phase I/II studies are expected to commence in the U.S. and Europe during the second quarter of 2012 and in Asia during the third quarter of 2012. Following the establishment of the appropriate dose, Clovis intends to study CO-1686 in an expansion cohort of NSCLC patients who have failed either Tarceva or Iressa and have developed a secondary mutation, T790M, which is the dominant resistance mechanism to Tarceva and Iressa. Clovis is developing a companion diagnostic in collaboration with its partner Roche Molecular Systems, Inc. to identify patients with the T790M mutation. Full Article
Clavis Pharma ASA and Clovis Oncology, Inc. Announce Size of Initial hENT1-Low Population in LEAP Trial with CP-4126
Clavis Pharma ASA announced that its partner, Clovis Oncology, Inc. (Clovis), has been informed by the Independent Data Monitoring Committee (IDMC) for the LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) pivotal trial of CP-4126 in metastatic pancreatic cancer, that approximately 65% of the enrolled patients have been classified as hENT1-low. CP-4126 (also known as CO-101) was licensed by Clovis from Clavis Pharma ASA in 2009 in a development and commercialization agreement worth up to USD 585 million. The analysis is based on 250 patients enrolled in the study through late October 2011, representing over two-thirds of the planned 360 patients expected to be enrolled in the study. The hENT1-low patients are the target population for CP- 4126, Clavis Pharma ASA's lipid-conjugated gemcitabine. LEAP is an international, randomized, controlled 360-patient, pivotal trial designed to demonstrate that CP-4126 improves overall survival versus gemcitabine in hENT1-low metastatic pancreatic cancer patients. LEAP is expected to be fully enrolled at the end of the first quarter of 2012, with first results expected to be reported by the end of 2012. Full Article

Earnings vs.
Estimates