| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | July 17, 2023 |
| Accession Number: | 0001193125-23-185162 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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| 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. |
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
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
SC 13G/A - Clovis Oncology, Inc. (0001466301) (Subject)
SC 13G - Clovis Oncology, Inc. (0001466301) (Subject)
SC 13G/A - Clovis Oncology, Inc. (0001466301) (Subject)
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
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
4 - Clovis Oncology, Inc. (0001466301) (Issuer)
4 - Clovis Oncology, Inc. (0001466301) (Issuer)
4 - Clovis Oncology, Inc. (0001466301) (Issuer)
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
EFFECT - Clovis Oncology, Inc. (0001466301) (Filer)
15-12G - Clovis Oncology, Inc. (0001466301) (Filer)
S-8 POS - Clovis Oncology, Inc. (0001466301) (Filer)
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
Gainers PLx Pharma (NASDAQ:PLXP) stock increased by 10.6% to $0.23 during Wednesday's after-market session. The market value of their outstanding shares is at $6.5 million. Clovis Oncology (NASDAQ:CLVS) shares rose 9.76% to $0.12. Trading volume for this security closed at 5.4 million, accounting for 125.9% of its average full-day volume over the last 100 days. The market value of their outstanding shares is at $16.7 million. OpGen (NASDAQ:OPGN) stock increased by 9.09% to $0.18. Today's trading volume for this security ended up closing at 2.9 million shares, which is 72.0 percent of its average volume over the last 100 days. The market value of their outstanding shares is at $9.6 million
On Wednesday, 115 stocks hit new 52-week lows. Noteable 52-Week Lows: The largest company by market cap to hit a new 52-week low was Petrobras Brasileiro (NYSE:PBR). Quotient (NASDAQ:QTNT) was the smallest firm by market cap to set a new 52-week low. Drive Shack (NYSE:DS) saw the largest move of the companies, as shares plummetted 64.32% to hit a new 52-week low. Ryvyl (NASDAQ:RVYL)'s stock bounced back the most, actually rising 0.0% after reaching its new 52-week low. The following stocks set new 52-week lows on Wednesday: Petrobras Brasileiro (NYSE:PBR) stock drifted down 8.38% on Wednesday morning to hit a new 52-week low of $9.25. Banco Santander (NYSE:BSBR) shares set a