Clovis Oncology, Inc., a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, the European Union, and internationally. The company offers Rubraca (rucaparib), an oral small molecule inhibitor of poly ADP-ribose polymerase for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, as well as for metastatic castration-resistant prostate cancer. It also provides lucitanib, an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRa/Ã), and fibroblast growth factor receptors 1 through 3 (FGFR 1-3); and FAP-2286, a peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein. The company distributes its products primarily through specialty pharmacies and distributors to patients and health care providers. Clovis Oncology, Inc. has license agreements with Pfizer Inc., AstraZeneca UK Limited, Advenchen Laboratories LLC, and 3B Pharmaceuticals GmbH, and Bristol Myers Squibb Company; and a partnership with Foundation Medicine, Inc. The company was incorporated in 2009 and is headquartered in Boulder, Colorado.
IPO Year: 2011
Exchange: NASDAQ
Website: clovisoncology.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 5/6/2022 | Buy → Neutral | H.C. Wainwright | |
| 9/21/2021 | $10.00 → $9.00 | Buy | HC Wainwright & Co. |
| 8/5/2021 | $12.00 → $10.00 | Buy | HC Wainwright & Co. |
Submission status for CLOVIS ONCOLOGY INC's drug RUBRACA (SUPPL-13) with active ingredient RUCAPARIB CAMSYLATE has changed to 'Approval' on 12/21/2022. Application Category: NDA, Application Number: 209115, Application Classification: Efficacy
Submission status for CLOVIS ONCOLOGY INC's drug RUBRACA (SUPPL-11) with active ingredient RUCAPARIB CAMSYLATE has changed to 'Approval' on 06/10/2022. Application Category: NDA, Application Number: 209115, Application Classification: Efficacy
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First presentation of initial LuMIERE Phase 1 clinical data for FAP-2286 targeted radiotherapy candidate at SNMMI demonstrated a manageable safety profile with preliminary evidence of activity Confirmed partial response in one patient in the lowest (3.7 GBq) dose cohort Recruitment of third of four planned dose cohorts is ongoing Initiation of Phase 2 expansion cohorts in multiple tumor types anticipated in Q4 2022 Phase 3 ATHENA trial evaluating Rubraca® (rucaparib) monotherapy versus placebo (ATHENA-MONO) in front-line maintenance treatment of ovarian cancer presented at 2022 ASCO Annual Meeting Simultaneous publication in the Journal of Clinical Oncology (JCO) Presented at
Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its second quarter 2022 financial results and provide an update on its clinical development programs and regulatory and business outlook on Monday, August 8, 2022, before the open of the US financial markets. 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 conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, 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 646.
ATHENA study evaluating Rubraca® (rucaparib) monotherapy versus placebo (ATHENA-MONO) in first-line ovarian cancer maintenance treatment successfully achieved the primary endpoint of improved PFS in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT) Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo in ITT population Late-breaker data to be presented in oral session at 2022 ASCO Annual Meeting on Monday, June 6 Two additional top-line Phase 3 data read-outs for Rubraca expected in next 12 months with potential to address ovarian and prostate cancer patient populations Initial Phase 1 clinical data for targeted radiothera
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 www.clovisoncology.com, 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 646.960.0682, conference ID: 2259685. About Clovis Oncology Clovis Oncology, Inc. is a biopharmaceutical company
ATHENA study evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) successfully achieved the primary endpoint of improved PFS in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT) Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo in the ITT population The exploratory PFS endpoints were also achieved in both HRD-negative and BRCA mutant subgroups of patients Safety of Rubraca observed in ATHENA-MONO was consistent with both the current US and European labels ATHENA-MONO results will serve as the basis of a supplemental NDA for US label expansion to be submitted during Q2 2022; European submission to follow during Q
Three top-line Phase 3 data read-outs for Rubraca expected in 2022, with potential to address larger ovarian and prostate cancer patient populations in earlier lines of therapy Phase 1/2 LuMIERE study of targeted radiotherapy candidate FAP-2286 ongoing; initial Phase 1 data expected at nuclear medicine-focused meetings in 2022, as well as initiation of Phase 2 expansion cohorts in multiple tumor types $148.8M in Rubraca® (rucaparib) global net product revenues for 2021, down 10% vs 2020; $36.0M in Rubraca global net product revenues for Q4 2021, down 5% vs Q3 2021 and 17% vs Q4 2020 Continued impact of COVID-19 on ovarian cancer diagnoses and treatments Reduction in R&D of $71.1M
Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its fourth quarter 2021 and year end 2021 financial results on Wednesday, February 23, 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 www.clovisoncology.com, 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 646.960.0682, conference ID: 2259685. About Clovis Oncology Clovis Oncology, Inc. is a
Estimated $35.5M - $36.1M in Rubraca® (rucaparib) global sales for Q4 2021 and $148.3M - $148.9M for FY 2021 Continuing impact on ovarian cancer diagnoses and treatments from COVID-19 Q4/FY 2021 Operating Results call planned for February 23, 2022 Company to present at J.P. Morgan Healthcare Conference on Wednesday, January 12 Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2021. The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures. Unaudited preliminary results include: $35
$37.9M in Rubraca® (rucaparib) global net product revenues for Q3 2021, up 3% over Q2 2021 and down 2% from Q3 2020 Three top-line Phase 3 data read-outs for Rubraca expected in 2022 with potential to address larger ovarian and prostate cancer patient populations in earlier lines of therapy Phase 1 LuMIERE study of targeted radiotherapy candidate FAP-2286 ongoing; initial Phase 1 data expected at medical meeting in 2022, as well as initiation of Phase 2 expansion cohorts in multiple tumor types Retired final $64.4M in principal amount of 2021 notes and raised net proceeds of $41.5M through ATM equity offering program in Q3 2021, complementing ongoing focus on cost control $171.9M i
Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its third quarter 2021 financial results on Wednesday, November 3, 2021, 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 www.clovisoncology.com, 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 646.960.0682, conference ID: 2259685. About Clovis Oncology Clovis Oncology, Inc. is a biopharmaceutical co
Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the appointment of Dr. Ronit Simantov to its Board of Directors, effective today. "I am very pleased to welcome Dr. Ronit Simantov to the Clovis Oncology Board of Directors, as she brings a wealth of expertise in oncology research and drug development to the role," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Dr. Simantov's extensive background and experience will support Clovis' key strategic priorities as we continue to advance both Rubraca's pipeline into a potentially broader label and the Company's early-stage pipeline of targeted radiotherapy candidates, including FAP-2286, into clinical development." Dr. Simanto
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Receives Commitment for up to $75 Million in Debtor-in-Possession Financing 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 various "first day" motions with the Bankruptcy Court request
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 Clinical Trial Updates" at the 29th Annual Prostate Cancer Foundation (PCF) Scientific Retreat. The presentation is available at https
Updated LuMIERE Phase 1 data demonstrated a manageable safety profile with some preliminary evidence of anti-tumor activity Eleven patients treated to date with 177Lu-FAP-2286 up to 7.4 GBq/dose No serious adverse events, treatment discontinuations, or deaths related to 177Lu-FAP-2286 observed Confirmed partial response (PR) in one patient who completed the maximum six administrations of 177Lu-FAP-2286 in the 3.7 GBq dose cohort Patient continues without disease progression or subsequent anti-cancer therapy more than twelve months after first dose Stable disease (SD) in one heavily pretreated patient who completed four administrations of 177Lu-FAP-2286 in the 5.55 GBq dose coho
TRITON3 study evaluating Rubraca monotherapy versus chemotherapy or second-line androgen deprivation therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) with mutations in BRCA or ATM achieved the primary endpoint of improved radiographic progression-free survival (rPFS) by independent radiology review (IRR) – Median rPFS of 11.2 months for Rubraca vs 6.4 months for control group in the BRCA subgroup – Median rPFS of 10.2 months for Rubraca vs 6.4 months for control group in the ITT population (inclusive of all patients with a BRCA or ATM mutation enrolled in TRITON3) Safety profile of Rubraca observed in TRITON3 was consistent with Rubraca labelling TRITO
Isotopia to supply its medical radioisotope, lutetium-177, for the clinical development of Clovis Oncology's targeted radionuclide therapy candidate FAP-2286 Clovis Oncology, Inc. (NASDAQ:CLVS) 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
Subgroup analysis from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented in a Mini Oral session at the ESMO Congress 2022 Results reinforce potential of Rubraca as a first-line maintenance treatment option in a broad population of patients with ovarian cancer irrespective of molecular characteristics, with or without high risk factors for progression 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
First presentation of initial LuMIERE Phase 1 clinical data for FAP-2286 targeted radiotherapy candidate at SNMMI demonstrated a manageable safety profile with preliminary evidence of activity Confirmed partial response in one patient in the lowest (3.7 GBq) dose cohort Recruitment of third of four planned dose cohorts is ongoing Initiation of Phase 2 expansion cohorts in multiple tumor types anticipated in Q4 2022 Phase 3 ATHENA trial evaluating Rubraca® (rucaparib) monotherapy versus placebo (ATHENA-MONO) in front-line maintenance treatment of ovarian cancer presented at 2022 ASCO Annual Meeting Simultaneous publication in the Journal of Clinical Oncology (JCO) Presented at
Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its second quarter 2022 financial results and provide an update on its clinical development programs and regulatory and business outlook on Monday, August 8, 2022, before the open of the US financial markets. 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 conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, 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 646.
NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, today announced the signing of a long-term supply agreement with Clovis Oncology, Inc. (NASDAQ:CLVS) for the therapeutic medical radioisotope, actinium-225 (Ac-225). Under terms of the agreement, NorthStar will provide Clovis with its environmentally preferred, high purity non-carrier-added (n.c.a.) Ac-225. Clovis plans to use NorthStar's Ac-225 to radiolabel its lead peptide-targeted radionuclide therapeutic candidate currently in development, FAP-2286, which targets fibroblast activation protein (FAP),
First presentation of initial LuMIERE Phase 1 data demonstrated a manageable safety profile with preliminary evidence of activity Nine patients treated to date with 177Lu-FAP-2286 up to 5.5 GBq/dose No serious adverse events, treatment discontinuations, deaths or dose-limiting toxicity events related to 177Lu-FAP-2286 observed Confirmed partial response in one patient who completed six administrations of 177Lu-FAP-2286 in the 3.7 GBq dose cohort Recruitment of the 7.4 GBq dose cohort is ongoing FAP-2286 has shown high tumor uptake and prolonged retention across a range of solid tumors Data from a separate UCSF investigator-initiated Phase 1 imaging study of 68Ga-FAP-2286 in s
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H.C. Wainwright downgraded Clovis Oncology from Buy to Neutral
HC Wainwright & Co. reiterated coverage of Clovis Oncology with a rating of Buy and set a new price target of $9.00 from $10.00 previously
HC Wainwright & Co. reiterated coverage of Clovis Oncology with a rating of Buy and set a new price target of $10.00 from $12.00 previously
HC Wainwright & Co. reiterated coverage of Clovis Oncology with a rating of Buy and set a new price target of $12.00 from $13.00 previously
HC Wainwright reiterated coverage of Clovis Oncology with a rating of Buy and set a new price target of $13.00 from $15.00 previously
On Thursday, 241 companies hit new 52-week lows. Significant Points From Today's 52-Week Lows: The largest company by market cap to set a new 52-week low was Tesla (NASDAQ:TSLA). Versus Systems (NASDAQ:VS) was the smallest company by market cap to set a new 52-week low. Third Harmonic Bio (NASDAQ:THRD)'s stock traded down the lowest, falling 75.68% to reach a new 52-week low. VirTra (NASDAQ:VTSI) saw the sharpest rebound, as shares ascended 0.0%, reversing after hiting a new 52-week low. On Thursday, the following stocks hit new 52-week lows: Tesla (NASDAQ:TSLA) stock hit a new 52-week low of $153.28. The stock was up 1.08% on the session. M&T Bank (NYSE:MTB) shares moved dow
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On Tuesday, 49 companies hit new 52-week lows. Key Facts About Today's 52-Week Lows: Tesla (NASDAQ:TSLA) is the largest company in terms of market cap to set a new 52-week low this morning. The smallest company by market cap to hit a new 52-week low was Quotient (NASDAQ:QTNT). IMV (NASDAQ:IMV)'s stock fell the most, as it traded down 899.04% to reach a new 52-week low. BiomX (AMEX:PHGE) shares bounced back the most, actually rising 0.05% after hiting a new 52-week low. On Tuesday, the following stocks broke to new 52-week lows: Tesla (NASDAQ:TSLA) stock set a new 52-week low of $163.50 on Tuesday, moving down 0.29%. Pacira BioSciences (NASDAQ:PCRX) stock set a new 52-week low
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Clovis Oncology Inc (NASDAQ:CLVS) has voluntarily initiated a Chapter 11 proceeding in the U.S. Bankruptcy Court and will seek to sell its assets through a court-supervised sales process. The Debtors have filed various "first day" motions with the Bankruptcy Court requesting customary relief that will enable them to transition into Chapter 11 without material disruption to their ordinary course operations. Related: Clovis Oncology Shares Nose-Dive As Potential Bankruptcy Filing Looms. Clovis has received a commitment of up to $75 million in a multi-draw debtor-in-possession (DIP) financing facility. Before the Chapter 11 filing, and subject to Bankruptcy Court approval, Clovis entered
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 various "first day" motions with the Bankruptcy Court requesting customary relief that will enable them to transition into Chapter 11 witho