reports
Clovis Oncology Files for Chapter 11 Protection and Enters into Agreem...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ:CLVS) (“Clovis” or the Company”), a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the U.S., Europe, and additional international markets, today announced that it and certain of its subsidiaries (collectively, the “Debtors”) have voluntarily initiated a Chapter 11 proceeding in the United States Bankruptcy Court for the District of Delaware (“Bankruptcy Court”) and will seek to sell their assets through a court supervised sales process. The Debtors have filed vario...
Clovis Oncology Presents Data from TRITON3 Phase 3 Trial of Rubraca® (...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations. The presentation titled, “TRITON3: A Phase 3 Study of Rucaparib vs. Physician’s Choice of Therapy in mCRPC Associated with Homologous Recombination Deficiency (HRD)” is being presented by Alan H. Bryce, MD, chair of the Division of Hematology and Medical Oncology at the Mayo Clinic and co-principal investigator of the TRITON3 trial during the session titled, “Novel C...
Clovis Oncology Highlights Updated LuMIERE Phase 1 Data of Targeted Ra...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral presentation at the 35th Annual European Association of Nuclear Medicine Congress (EANM) detailing updated Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study investigating the safety, pharmacokinetics, dosimetry, and preliminary anti-tumor activity of its targeted radiotherapy candidate, FAP-2286 labeled with lutetium-177 (177Lu-FAP-2286). Overall, in eleven patients treated in the first three dose cohorts, 177Lu-FAP-2286 demonstrated a manageable safety profile and enc...
TRITON3 Phase 3 Trial of Rubraca® (rucaparib) Achieves Primary Endpoin...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive top-line data from the Phase 3, open-label, multicenter, randomized TRITON3 trial demonstrating that Rubraca monotherapy treatment achieved the primary endpoint of significantly improved radiographic progression-free survival (rPFS) by independent radiology review (IRR) compared with the control group, which consisted of physician’s choice of docetaxel, abiraterone acetate, or enzalutamide. Benefit was observed in both primary efficacy analyses of patients with chemotherapy-naïve metastatic castrati...
Clovis Oncology and Isotopia Announce Lutetium-177 Clinical Supply Agr...
BOULDER, Colo. & PETACH TIKVA, Israel--(BUSINESS WIRE)-- and Isotopia Molecular Imaging Ltd. today announced the signing of a clinical supply agreement that provides Clovis Oncology with Isotopia’s lutetium-177 (177Lu) n.c.a. for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate. FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanc...
Clovis Oncology Submits Applications for Rubraca® Label Expansion in t...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that it has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) and a Type II variation with the European Medicines Agency (EMA) for approval of Rubraca® (rucaparib) as first-line maintenance treatment for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy. The Company believes that the encouraging PFS results, the primary endpoint of the study, are strongly supportive of an approval a...
Clovis Oncology’s Rubraca® (Rucaparib) as First-Line Maintenance Treat...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS), today announced results from a subgroup analysis of data from the monotherapy comparison of the randomized, Phase 3 ATHENA (GOG-3020/ENGOT-ov45) trial (ATHENA-MONO). These data showed that Rubraca as first-line maintenance treatment improved progression-free survival (PFS) versus placebo across disease risk subgroups including surgical outcome, response to first-line chemotherapy, and additional analyses in other subgroups. The data were presented by Rebecca S. Kristeleit, MD, PhD, of Guy’s and St. Thomas’ NHS Foundation T...
Clovis Oncology Announces Second Quarter 2022 Operating Results and Pr...
BOULDER, Colo.--(BUSINESS WIRE)-- , Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2022, and provided an update on the Company’s and regulatory and commercial outlook. “We achieved a key milestone in the second quarter, with the presentations of the first clinical data from the LuMIERE trial of FAP-2286 and from the ongoing imaging-only investigator-initiated study. In addition to seeing the first evidence of safety and clinical activity, these initial results further demonstrate that fibroblast activation protein, or FAP, is a promising theranostic target with ...
CORRECTING and REPLACING Clovis Oncology to Announce Second Quarter 20...
BOULDER, Colo.--(BUSINESS WIRE)-- First paragraph, second sentence of release should read: Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss Clovis’ results and business outlook in greater detail. (instead of Clovis’ senior management will host a conference call and live audio webcast at 6:30am ET to discuss Clovis’ results and business outlook in greater detail.). The updated release reads: CLOVIS ONCOLOGY TO ANNOUNCE SECOND QUARTER 2022 FINANCIAL RESULTS AND HOST WEBCAST CONFERENCE CALL ON AUGUST 8 Clovis Oncology, Inc. (NASDAQ: CLVS) wil...
Clovis Oncology Highlights Phase 1 Data from Ongoing Clinical Studies ...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral presentation detailing initial Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study investigating the safety, pharmacokinetics, dosimetry, and preliminary antitumor activity of its targeted radiotherapy candidate, FAP-2286 labelled with lutetium-177 (177Lu-FAP-2286). Overall, in nine patients treated in the first two dose cohorts,177Lu-FAP-2286 demonstrated a manageable safety profile and encouraging evidence of activity, including a confirmed RECIST partial response in o...
Clovis Oncology’s Rubraca® (Rucaparib) as First-Line Maintenance Treat...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today the first presentation of data from the monotherapy arm of the randomized, Phase 3 ATHENA (GOG-3020/ENGOT-ov45) trial (ATHENA-MONO) as a late-breaking oral abstract (LBA5500) to be presented on Monday, June 6, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data demonstrate that Rubraca as first-line maintenance treatment significantly improved investigator-assessed progression-free survival (PFS) compared with placebo in women with advanced ovarian cancer irrespective...
Clovis Oncology to Present at the BofA Securities 2022 Healthcare Conf...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the BofA Securities 2022 Healthcare Conference on Wednesday, May 11, 2022, at 10:00 a.m. Pacific time. The conference will be held at the Encore hotel in Las Vegas. A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at . Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days. About Clovis Oncology Clovis...
Clovis Oncology Announces First Quarter 2022 Operating Results and Pro...
BOULDER, Colo.--(BUSINESS WIRE)-- , Inc. (NASDAQ:CLVS) reported financial results for the quarter ended March 31, 2022, and provided an update on the Company’s and regulatory and commercial outlook. “We entered 2022 knowing that it would be the most significant year for clinical data read-outs in the Company’s history, and we are obviously pleased that the results from the ATHENA-MONO study of Rubraca, the first of those read-outs, exceeded our expectations. Importantly, we believe that the positive results from ATHENA-MONO, which will be described in full at ASCO next month, demonstrate the...
Clovis Oncology Highlights Rubraca® (Rucaparib) and FAP-2286 Data to b...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that seven abstracts from the company’s pipeline, including late-breaking data from the ATHENA-MONO Phase 3 clinical trial evaluating Rubraca monotherapy versus placebo and imaging of solid tumors using FAP-2286, will be presented in oral and poster sessions during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held June 3-7, 2022, in Chicago. Three additional retrospective analyses evaluating Rubraca and PARP inhibitors will be published online during the meeting. “The wealth of data...
Clovis Oncology to Announce First Quarter 2022 Financial Results and H...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its first quarter 2022 financial results on Wednesday, May 4, 2022, before the open of the US financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss the Company’s results in greater detail. The conference call will be simultaneously webcast on the Clovis Oncology website , and a replay of the webcast will be available for 30 days. Dial-in numbers for the conference call are as follows: US participants 888.440.4615, International participants 64...
Clovis Oncology’s Rubraca® (Rucaparib) Significantly Improves Progress...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive top-line data from the monotherapy arm of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo. Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombina...
Due to a more favourable environment, CLOVIS ONCOLOGY slightly increas...
CLOVIS ONCOLOGY (US), a company active in the Biotechnology industry, slightly increases its general evaluation. The independent financial analyst theScreener just confirmed the stock market behaviour of the title as risky. At the fundamental level, theScreener confirms the rating of 0 out of 4 stars; given the more favourable environment, the title's overall rating is upgraded to Slightly Negative even if it remains under pressure. As of the analysis date March 18, 2022, the closing price was U...
Clovis Oncology and Evergreen Theragnostics Initiate Development and M...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286). Under the agreement, Clovis and Evergreen intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies. “This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286,” said Patrick J....
Clovis Oncology Highlights Ongoing Phase 1/2 LuMIERE Clinical Study an...
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced a Trial-in-Progress poster detailing the Phase 1 portion of the LuMIERE clinical study for its targeted radiotherapy candidate FAP-2286 and a presentation titled “Initial Experience with FAP-2286 Imaging” related to an ongoing investigator-initiated trial (IIT) evaluating the ability of imaging agent gallium-68 (68Ga)-FAP-2286 to detect metastatic cancer in patients with solid tumors. These data will be presented by Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomed...
Clovis Oncology Announces 2021 Operating Results and Anticipated 2022 ...
BOULDER, Colo.--(BUSINESS WIRE)-- , Inc. (NASDAQ:CLVS) reported financial results for the quarter ended December 31, 2021, and provided an update on the Company’s and regulatory and commercial outlook. “We have been looking forward to 2022 for a long time, which we anticipate will be the most significant year for clinical data read-outs in the Company’s history,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Despite the ongoing impact of COVID-19 on ovarian cancer diagnoses and treatments, and consequently on Rubraca revenues in 2021, our commitment to Phase 3 trials has po...
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