DOCSLIB.ORG

FDA Requests Belviq Be Pulled from the US Market Due to Cancer Risk

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
FDA Requests Belviq Be Pulled from the US Market Due to Cancer Risk No. 3992 February 21, 2020 Belviq has not been a big commercial seller in the US, but Eisai had been hoping the positive cardiovascular outcomes trial could mark a new chapter for the troubled weight loss pill. The company reported nine-month revenues of ¥4.61bn ($42m) for Belviq in January. NAIL IN COFFIN Now, the FDA’s request to remove the drug from the market feels like anoth- er nail in the coffin for a trio of obesity drugs that launched in the early part of the last decade with a lot of fanfare but failed commercially. (Also see “10 Drug Launch Flops Of The Decade “ - Scrip, The last of a trio of obesity drugs that 8 Jan, 2020.) The big problem for the launched early in the last decade to crash drugs was around the perceived modest efficacy and uncertain risks. Belviq was the first of those drugs to reach the market in 2012. It was ini- FDA Requests Belviq Be Pulled From tially developed by Arena Pharmaceu- ticals and partnered with Eisai in 2010. The US Market Due To Cancer Risk (Also see “Arena Scores Hefty Obesity Drug Deal With Eisai Ahead Of PDUFA JESSICA MERRILL [email protected] Date” - Pink Sheet, 1 Jul, 2010.) Arena handed over full commercial rights to he US Food and Drug Adminis- did not improve cardiovascular outcomes the product to Eisai in 2017 to focus on tration has requested that Eisai either. At the time the data was first re- other drugs. T Co. Ltd. voluntarily withdraw the leased in mid-2018, Eisai did not highlight Two other drugs followed behind Bel- obesity pills Belviq and Belviq XR (lorca- cancer as a safety signal. (Also see “Eisai’s viq: Vivus Inc.’s Qysmia (phentermine/ serin) from the US market because of an Obesity Drug Belviq Passes Cardiovascu- topiramate) and Takeda Pharmaceuti- increased risk of cancer. The announce- lar Outcomes Test” - Scrip, 17 Jul, 2018.) cal Co. Ltd../Orexigen Therapeutics Inc.’s ment on 13 February comes after Eisai The FDA had required the cardiovascular Contrave (naltrexone/bupropion). Orex- demonstrated the cardiovascular safety of outcomes trial (CVOT) as a post-approval igen eventually filed for bankruptcy, and Belviq in an outcomes trial, but that same commitment. while Vivus continues to market Qysmia, trial showed an increased risk of cancer “Patients should stop using the medi- it only generated $9.5m in the third occurrence. cation Belviq and Belviq XR and talk to quarter of 2019. The FDA issued an alert in January no- their health care professionals about Published online 13 February 2020 tifying the public that it was assessing the other treatment options for weight loss,” safety of Belviq for a potential increased Center for Drug Evaluation and Research As Belviq Goes Off risk of cancer. In the 12,000-patient CA- Janet Woodcock said in a statement. The India Market, Patent Case MELLIA-TIMI 61 trial, Eisai showed Belviq agency did not recommend special can- May Fizzle: did not increase major cardiovascular cer screening for patients who have taken https://bit.ly/2SSaZgw events compared to placebo, but the drug Belviq outside of routine tests. FOR THE LATEST BUSINESS INSIGHT ON THE BIOPHARMA INDUSTRY VISIT: SCRIP.PHARMAINTELLIGENCE.INFORMA.COM Deal Making Move Over CAR-T Pharma On Coronavirus A good year expected, despite Takeda’s Off-The-Shelf CAR-NK A passing nuisance or a real worry? US election uncertainty (p10) data excite (p14) (p18) IN THIS ISSUE from the executive editor [email protected] How worried are you about coronavirus? And if you squarely during the Q4 reporting season and concerns at do have any fears, do they relate more to your per- present are largely confined to China. With the obvious sonal safety, or that of your business? I’m firmly in the caveats firmly in place, most said the disruption was man- not-worried-yet camp; a quick Amazon search for face ageable and expected the outbreak to be relatively short- masks ended with a closed laptop as soon as I saw their lived. And many are joining in efforts to tackle the disease. price, although I do admit to having upped the hand- Still, the arrival of an unknown infectious disease washing (both frequency and thoroughness). evokes deep-seated fears. Just today in the UK press, Three years of studying microbiology at university may amid all the coronavirus updates, was news of the dis- have left me with a healthy respect for viruses, but 20 years covery in rural Lincolnshire of a mass grave of 14th of covering pharma has engendered some faith, at least, in century victims of the Black Death – the findings prov- its ability to Do Something about the current outbreak. ing that it was not just the populous towns where the Fears over SARS, MERS and H1N1 waxed then waned, af- normal systems for burial broke down under the sheer ter all, and hopefully COVID-19 will be no different. volume of bodies as half the population of Europe was Such sanguinity appears shared by pharma heads. As wiped out. A reminder, if any were needed, not to get we report in p18, only a few firms addressed the issue too complacent. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Christopher Keeling Paul Wilkinson Karen Coleman HEAD OF SUBSCRIPTIONS PUBLICATION DESIGN Dan Simmons, Gayle Rembold Furbert Shinbo Hidenaga EDITORS IN CHIEF Andrea Charles EDITORIAL OFFICE Ian Haydock (Asia) John Davis Blue Fin Building Eleanor Malone (Europe) Kevin Grogan 3rd Floor, 110 Southwark St Denise Peterson (US) Andrew McConaghie London, SE1 0TA Ian Schofield CUSTOMER SERVICES EXECUTIVE EDITORS Vibha Sharma US Toll-Free: +1 888 670 8900 COMMERCIAL Sten Stovall Alexandra Shimmings (Europe) US Toll: +1 908 547 2200 UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) US Australia: +61 2 8705 6907 POLICY AND REGULATORY Michael Cipriano Japan: +81 3 6273 4260 Maureen Kenny (Europe) Derrick Gingery Email: clientservices@ Nielsen Hobbs (US) Joseph Haas pharma.informa.com Mandy Jackson ASIA Cathy Kelly Anju Ghangurde Jessica Merrill TO SUBSCRIBE, VISIT scrip.pharmaintelligence.informa.com Vibha Ravi Leah Samuel Jung Won Shin Brenda Sandburg TO ADVERTISE, CONTACT Brian Yang Bridget Silverman [email protected] Sue Sutter EUROPE All stock images in this publication Neena Brizmohun courtesy of www.shutterstock.com Francesca Bruce unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2020: All rights reserved. ISSN 0143 7690. 2 | Scrip | February 21, 2020 © Informa UK Ltd 2020 GlycoMimetics Dr Reddy’s Alzheimer’s Defeats Deal Off New Move Pharma Again Balance 20 6 9 15 exclusive online content inside: COVER / FDA Requests Belviq Be Pulled From The US Market Due 89Bio’s NASH Hopes Hang On To Cancer Risk Demonstrating Best-In-Class FGF21 Profile 4 AstraZeneca Returns To Growth, But Coronavirus Likely To Hit JOSEPH HAAS [email protected] China Revenues 5 Teva Edges Closer To Growth, But With A Big Overhang 6 Ipsen Upbeat Despite Palovarotene Program Pain 8 Pfizer Ends Pact With GlycoMimetics After SCD Failure 8 It’s A Deal, Finally: Dr Reddy’s Snaps Up Wockhardt’s Branded Gx Business 10 A Positive Outlook For Deals, With Election Year Caveats 11 Sandoz Optimistic On Biosimilars As It Reprioritizes US Portfolio 13 Novartis And UK Launch Partnership On Groundbreaking Recent entrants, including some big pharma players, Cardiovascular Prevention Trial threaten to make the fibroblast growth factor (FGF) ana- log class another crowded field of clinical development 14 Strong Early Promise For Takeda ‘Off The Shelf’ CAR-NK for non-alcoholic steatohepatitis, but 89bio Inc. thinks its Therapy mid-stage FGF21 analog could prove best in class with less frequent dosing than a Phase II FGF21 candidate at Bris- 15 Another Alzheimer’s Setback As Roche And Lilly Drugs Fail tol-Myers Squibb Co. and offer a better safety profile than 17 Fennec Nears Market For Chemo-Induced Hearing Loss NGM Biopharmaceuticals Inc.’s Phase IIb FGF19 analog. In Children Founded in Israel in May 2018 with the licensing of BIO89-100 (then called TEVA47948) from Teva, 89Bio now 18 Keytruda Closing In On First-Line Metastatic Triple-Negative operates mainly out of San Francisco. It anticipates report- Breast Cancer ing out Phase IIa data for BIO89-100 in NASH during the second half of 2020 – the ongoing Phase Ib/IIa study is 18 Global Catastrophe Or Passing Nuisance? Pharma’s testing once-weekly and twice-weekly injectable dosing Coronavirus Views of the glycopegylated FGF21 analog. The firm also plans to soon initiate a Phase II study of the candidate in severe 21 Stockwatch: Coronavirus Takes A Bite Out Of AstraZeneca’s Guidance, GSK and AbbVie Get Spinning hypertriglyceridemia with data expected during the first half of 2020. 22 Pipeline Watch Published online 11 February 2020 To read the rest of this story go to: https://bit.ly/2uIEBVG 23 Appointments @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com February 21, 2020 | Scrip | 3 Q4 RESULTS AstraZeneca Returns To Growth, But Coronavirus Likely To Hit China Revenues ANDREW MCCONAGHIE [email protected] straZeneca PLC has recorded its (benralizumab), though these were offset Calquence (acalabrutinib) in leukemia, as first full year of revenue growth in by a better-than-expected showing from well as several approvals in China at the Aeight years, bouncing back thanks aging respiratory blockbuster Symbicort end of the year, including Lynparza in first- to its fast-growing new cancer drug portfo- (budesonide/formoterol). line ovarian cancer. (Also see “AZ Closer To lio and expansion in China. But CEO Pascal For 2020, the company is forecasting Second Enhertu OK After Gastric Cancer Soriot warned the Covid-19 virus outbreak revenue growth in the high-single to Success” - Scrip, 27 Jan, 2020.) could have an impact on 2020’s numbers.
Load more

Recommended publications
  • List of Marginable OTC Stocks
    List of Marginable OTC Stocks @ENTERTAINMENT, INC. ABACAN RESOURCE CORPORATION ACE CASH EXPRESS, INC. $.01 par common No par common $.01 par common 1ST BANCORP (Indiana) ABACUS DIRECT CORPORATION ACE*COMM CORPORATION $1.00 par common $.001 par common $.01 par common 1ST BERGEN BANCORP ABAXIS, INC. ACETO CORPORATION No par common No par common $.01 par common 1ST SOURCE CORPORATION ABC BANCORP (Georgia) ACMAT CORPORATION $1.00 par common $1.00 par common Class A, no par common Fixed rate cumulative trust preferred securities of 1st Source Capital ABC DISPENSING TECHNOLOGIES, INC. ACORN PRODUCTS, INC. Floating rate cumulative trust preferred $.01 par common $.001 par common securities of 1st Source ABC RAIL PRODUCTS CORPORATION ACRES GAMING INCORPORATED 3-D GEOPHYSICAL, INC. $.01 par common $.01 par common $.01 par common ABER RESOURCES LTD. ACRODYNE COMMUNICATIONS, INC. 3-D SYSTEMS CORPORATION No par common $.01 par common $.001 par common ABIGAIL ADAMS NATIONAL BANCORP, INC. †ACSYS, INC. 3COM CORPORATION $.01 par common No par common No par common ABINGTON BANCORP, INC. (Massachusetts) ACT MANUFACTURING, INC. 3D LABS INC. LIMITED $.10 par common $.01 par common $.01 par common ABIOMED, INC. ACT NETWORKS, INC. 3DFX INTERACTIVE, INC. $.01 par common $.01 par common No par common ABLE TELCOM HOLDING CORPORATION ACT TELECONFERENCING, INC. 3DO COMPANY, THE $.001 par common No par common $.01 par common ABR INFORMATION SERVICES INC. ACTEL CORPORATION 3DX TECHNOLOGIES, INC. $.01 par common $.001 par common $.01 par common ABRAMS INDUSTRIES, INC. ACTION PERFORMANCE COMPANIES, INC. 4 KIDS ENTERTAINMENT, INC. $1.00 par common $.01 par common $.01 par common 4FRONT TECHNOLOGIES, INC.
    [Show full text]
  • Guidelines with Regard to the Composition, Calculation and Management of the Index
    INDEX METHODOLOGY Solactive Pharma Breakthrough Value Index Version 2.1 dated September 03, 2020 Contents Important Information 1. Index specifications 1.1 Short Name and ISIN 1.2 Initial Value 1.3 Distribution 1.4 Prices and Calculation Frequency 1.5 Weighting 1.6 Index Committee 1.7 Publication 1.8 Historical Data 1.9 Licensing 2. Composition of the Index 2.1 Selection of the Index Components 2.2 Ordinary Adjustment 2.3 Extraordinary Adjustment 3. Calculation of the Index 3.1 Index Formula 3.2 Accuracy 3.3 Adjustments 3.4 Dividends and other Distributions 3.5 Corporate Actions 3.6 Correction Policy 3.7 Market Disruption 3.8 Consequences of an Extraordinary Event 4. Definitions 5. Appendix 5.1 Contact Details 5.2 Calculation of the Index – Change in Calculation Method 2 Important Information This document (“Index Methodology Document”) contains the underlying principles and regulations regarding the structure and the operating of the Solactive Pharma Breakthrough Value Index. Solactive AG shall make every effort to implement regulations. Solactive AG does not offer any explicit or tacit guarantee or assurance, neither pertaining to the results from the use of the Index nor the Index value at any certain point in time nor in any other respect. The Index is merely calculated and published by Solactive AG and it strives to the best of its ability to ensure the correctness of the calculation. There is no obligation for Solactive AG – irrespective of possible obligations to issuers – to advise third parties, including investors and/or financial intermediaries, of any errors in the Index.
    [Show full text]
  • Healthcare & Life Sciences Industry Update
    Healthcare & Life Sciences Industry Update August 2011 Member FINRA/SIPC www.harriswilliams.com What We’ve Been Reading August 2011 • The biggest story from inside the Beltway over the last month was the battle and eventual deal to raise the U.S. debt ceiling to avoid an impending August 2nd default. The Budget Control Act of 2011 will raise the debt ceiling by $2.1-$2.4 trillion, while reducing spending by approximately $2.1 trillion over the next decade. In an interesting post-deal analysis, Michael Hiltzik of the Los Angeles Times notes that despite the protracted negotiations over a broad spectrum of cost-cutting measures, healthcare was not raised as a primary issue. Some have found this especially concerning, considering the outsized portion of the Federal Budget currently allocated to healthcare spending, which is forecast to rise in the coming years. A recent article in The Economist, entitled “Looking to Uncle Sam” makes this point and goes further to suggest that Centers for Medicare & Medicaid Services (CMS) actuaries may be underestimating future increases in Medicare and Medicaid spending. • One potential reason CMS actuaries may be underestimating the future costs of Medicare and Medicaid relates to healthcare reform’s effect on employee benefits, and specifically, the 2014 switch to subsidized exchange policies. A recent report by McKinsey & Company estimates that approximately 30% of employers will stop offering employer- sponsored insurance (ESI) when this switch is made, as opposed to the 7% estimated by the Congressional Budget Office. An ESI exodus of this magnitude could cause substantial strain on an already robust government healthcare budget.
    [Show full text]
  • 2016 Medicines in Development for Rare Diseases a LIST of ORPHAN DRUGS in the PIPELINE
    2016 Medicines in Development for Rare Diseases A LIST OF ORPHAN DRUGS IN THE PIPELINE Autoimmune Diseases Product Name Sponsor Official FDA Designation* Development Status Actemra® Genentech treatment of systemic sclerosis Phase III tocilizumab South San Francisco, CA www.gene.com Adempas® Bayer HealthCare Pharmaceuticals treatment of systemic sclerosis Phase II riociguat Whippany, NJ www.pharma.bayer.com ARA 290 Araim Pharmaceuticals treatment of neuropathic pain in patients Phase II Tarrytown, NY with sarcoidosis www.ariampharma.com ARG201 arGentis Pharmaceuticals treatment of diffuse systemic sclerosis Phase II (type 1 native bovine skin Collierville, TN www.argentisrx.com collagen) BYM338 Novartis Pharmaceuticals treatment of inclusion body myositis Phase III (bimagrumab) East Hanover, NJ www.novartis.com CCX168 ChemoCentryx treatment of anti-neutrophil cytoplasmic Phase II (5a receptor antagonist) Mountain View, CA auto-antibodies associated vasculitides www.chemocentryx.com (granulomatosis with polyangitis or Wegener's granulomatosis), microscopic polyangitis, and Churg-Strauss syndrome * This designation is issued by the FDA's Office of Orphan Products Development while the drug is still in development. The designation makes the sponsor of the drug eligible for entitlements under the Orphan Drug Act of 1983. The entitlements include seven years of marketing exclusivity following FDA approval of the drug for the designated use. Medicines in Development: Rare Diseases | 2016 1 Autoimmune Diseases Product Name Sponsor Official FDA
    [Show full text]
  • ACC.17 Program Committee Disclosures.Xlsx
    ACC.17 Program Committee Disclosures of Relationships With Industry Name Disclosures Brian G. Abbott, MD, FACC Nothing to Disclose J. Dawn Abbott, MD, FACC DATA SAFETY MONITORING BOARD - Pfizer Nazem Akoum, MD, FACC CONSULTANT FEES/HONORARIA - Biotronik Karen P. Alexander, MD, FACC CONSULTANT FEES/HONORARIA - Gilead Sciences, Inc.; DATA SAFETY MONITORING BOARD - CytRx; RESEARCH/RESEARCH GRANTS - gilead, Regeneron, Sanofi Aventis Mouaz H. Al-Mallah, MD, FACC CONSULTANT FEES/HONORARIA - GE Healthcare; SPEAKER’S BUREAU - Pfizer Inc, Philips Jesus G. Almendral, MD, FACC Nothing to Disclose Aimee K. Armstrong, MD, FACC CONSULTANT FEES/HONORARIA - B. Braun Interventional Systems Inc., Edwards Lifesciences, Siemens Healthcare AX, St. Jude Medical; RESEARCH/RESEARCH GRANTS - Edwards Lifesciences, MEDTRONIC Herbert D. Aronow, MD, MPH, Nothing to Disclose FACC Samuel J. Asirvatham, MBBS, CONSULTANT FEES/HONORARIA - Abiomed, AtriCure, Biosense Webster, Biotronik, FACC Boston Scientific, Elsevier, Medtelligence, MEDTRONIC, Sanofi Aventis, St. Jude Medical, Wolters Kluwer, Zoll Alison Bailey, MD, FACC RESEARCH/RESEARCH GRANTS - CSL Behring Subhash Banerjee, MD, FACC CONSULTANT FEES/HONORARIA - Boston Scientific; OWNERSHIP INTEREST/PARTNERSHIP/PRINCIPAL - Mdcare Global LLC; RESEARCH/RESEARCH GRANTS - Boston Scientific Corporation; SPEAKER’S BUREAU - CSI, MEDTRONIC Geoffrey D. Barnes, MD, FACC CONSULTANT FEES/HONORARIA - Portola; RESEARCH/RESEARCH GRANTS - Blue Cross Blue Shield of Michigan, BMS/Pfizer Theodore A. Bass, MD, FACC Nothing to Disclose
    [Show full text]
  • Safety and Activity of Autologous T Cells with Enhanced
    D’Angelo SP1, Blay J-Y2, Chow W3, Demetri G4, Thistlethwaite F5, Sen S6, Razak A7, Safety and Activity of Autologous T Cells With Enhanced NY-ESO-1–Specific T-Cell Receptor Haanen J8, Noujaim J9, Johnson ML10, Laetsch TW11, Chiou VL12, Pearce L12, Faitg TH12, Ji R12, Johnson LA12, Shalabi A12, Thornton K4, Mackall C13, Van Tine BA14 (GSK3377794) in HLA-A*02+ Previously-Treated and -Untreated Patients With Advanced 1Memorial Sloan Kettering Cancer Center, New York, NY, USA; 2Département de Cancérologie Médicale, Centre Léon Bérard, Lyon, France; 3City of Hope Comprehensive Cancer Center, Duarte, CA, USA; 4Dana-Farber Cancer Institute and Ludwig Center at Harvard Medical School, Boston, MA, USA; 5The Christie NHS Foundation Trust and University of Manchester, Manchester, UK; 6Sarah Cannon Research Metastatic/Unresectable Synovial Sarcoma: A Master Protocol Study Design (IGNYTE-ESO) Institute, Denver, CO, USA; 7Princess Margaret Cancer Centre and Mount Sinai Hospital, Toronto, ON, Canada; 8Plesmanlaan 121, Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, Netherlands; 9Institut D’Hématologie-Oncologie, Hôpital Maisonneuve-Rosemont, Montreal, Poster No. 459 QC, Canada; 10Sarah Cannon Research Institute, Nashville, TN, USA; 11University of Texas Southwestern Medical Center, Dallas, TX, USA; 12GlaxoSmithKline, Philadelphia, PA, USA; 13Stanford University, Palo Alto, CA, USA; 14Washington University in St. Louis, St. Louis, MO, USA Background Study design Unmet need This trial (IGNYTE-ESO; NCT03967223) has a Master Protocol design consisting of
    [Show full text]
  • What's Inside
    Newsletter A publication of the Controlled Release Society Volume 31 • Number 3 • 2014 What’s Inside 41st CRS Annual Meeting & Exposition Formulating Amorphous Drug Delivery System Using Low-Molecular-Weight Components as Stabilizers Microencapsulation Technology Interview with Frank Szoka DDTR: Proceedings of the Drug Delivery Australia Symposium Patent Watch Volunteer Spotlight Preclinical Sciences & Animal Health Advances CRS Annual Meeting and Exposition July 13–16, 2014 • Chicago, Illinois, U.S.A. The entire meeting is housed in the Access the Best in Delivery Science Hilton Chicago. Join us at the Hilton Chicago to connect with Book now! those in the discovery, development, and delivery continuum. • Learn from world-renowned researchers and thought leaders. • Be a part of the global discussion on matters that affect the future of our science. • Visit the exposition for the newest technologies, products, and services. • Connect with colleagues from around the world. ©City of Chicago Exposition Space and Sponsorships Available ©Mopic / Shutterstock.com of Delivery Technology: Innovation to Commercialization controlledreleasesociety.org Newsletter Charles Frey Vol. 31 • No. 3 • 2014 Editor Table of Contents From the Editor .................................................................................................................. 2 From the President ............................................................................................................ 3 41st CRS Annual Meeting & Exposition ..........................................................................
    [Show full text]
  • Company Description Key Points Geovax Labs, Inc. GOVX-NASDAQ
    GeoVax Labs, Inc. GOVX‐NASDAQ EXECUTIVE INFORMATIONAL OVERVIEW® October 22, 2020 Company Description GeoVax Labs, Inc. (“GeoVax” or “the Company”) is a clinical‐stage biotechnology company developing preventive and therapeutic human vaccines against infectious diseases and cancer. The GeoVax Labs, Inc. Company’s proprietary GV‐MVA‐VLP™ vector vaccine technology 1900 Lake Park Drive, Suite 380 utilizes a Modified Vaccinia Ankara (MVA) vector, a large virus Atlanta, GA 30080 capable of carrying several vaccine antigens, that are expressed as Phone (678) 384‐7220 non‐infectious virus‐like particles (VLPs) in the individual receiving Fax (678) 384‐7281 the vaccine (in vivo). VLPs mimic a natural infection, stimulating both www.geovax.com the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection through durable immune Ticker (Exchange) GOVX (NASDAQ) responses. GeoVax is capitalizing on the safety and efficacy of its Recent Price (10/22/2020) $3.19 technology platform to address the urgent need for a COVID‐19 Shares Outstanding* 3.8 million vaccine and is also developing vaccines against human immunodeficiency virus (HIV), Zika virus (ZIKV), hemorrhagic fever Market Capitalization $11.4 million (HF) viruses (Ebola, Sudan, Marburg, and Lassa Fever) and malaria. Average 3‐month Volume 377,347 Furthermore, the Company is applying its MVA‐VLP technology to Insider Ownership +>5% 6.9% cancer immunotherapy (immuno‐oncology). Institutional Ownership 25% EPS (06/30/2020)* ($0.66) Key Points Employees 8 GeoVax’s recently completed $12.8 million public offering and its * EPS figure for Q2 2020 has been restated for the 1:20 reverse uplist to Nasdaq give it the financial resources it has lacked in recent split in September 2020.
    [Show full text]
  • Small-Cap Research [email protected]
    March 12, 2012 Grant Zeng, CFA 312-265-9466 Small-Cap Research [email protected] scr.zacks.com 111 North Canal Street, Chicago, IL 60606 Cytrx Corp (CYTR-NASDAQ) CYTR: continues to make progress in advancing its pipeline--Outperform OUTLOOK CytRx is a biopharmaceutical company with a focus on oncology. The Company has three candidates in middle to late stage development targeting various cancer indications. The most advanced candidate is Current Recommendation Outperform tamibarotene which is in a pivotal clinical trial for Prior Recommendation Neutral acute promyelocytic leukemia (APL). The combined Date of Last Change 02/23/2012 market opportunity for CytRx s pipeline is huge. The Company s strategy is to develop drugs with known mechanisms of action which will minimize Current Price (03/09/12) $0.33 operational risks. CytRx is well capitalized with a $1.35 Twelve-Month Target Price strong balance sheet which sets it apart from its peers. Current valuation is low based on the Company s fundamentals. Therefore, we assign a SUMMARY DATA market Outperform rating on CytRx. 52-Week High $0.99 Risk Level Above Avg., 52-Week Low $0.26 Type of Stock Small-Growth One-Year Return (%) -61.64 Industry Med-Biomed/Gene Beta 1.43 Zacks Rank in Industry N/A Average Daily Volume (sh) 1,088,023 ZACKS ESTIMATES Shares Outstanding (mil) 148 Market Capitalization ($mil) $49 Revenue (in millions of $) Short Interest Ratio (days) 0.55 Q1 Q2 Q3 Q4 Year Institutional Ownership (%) 12 Insider Ownership (%) 8 (Mar) (Jun) (Sep) (Dec) (Dec) 2010 0.00 A 0.00 A 0.00 A 0.10 A 0.10 A Annual Cash Dividend $0.00 2011 0.00 A 0.15 A 0.00 A 0.00 E 0.15 E Dividend Yield (%) 0.00 2012 0.00 E 2013 2.73 E 5-Yr.
    [Show full text]
  • ANNUAL REPORT PURSUANT to SECTION 13 OR 15(D)OF the SECURITIES EXCHANGE ACT of 1934
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) 5 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2005 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 Commission File No. 0-15327 CytRx Corporation (Exact name of Registrant as specified in its charter) Delaware 58-1642740 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 11726 San Vicente Blvd, Suite 650, Los Angeles, California 90049 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (310) 826-5648 ________________ Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.001 par value per share Indicate by check mark with the Registrant is a well-known seasoned issuer (as defined in Securities Act Rule 405). Yes No 5 Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes No 5 Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. Yes 5 No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K 5 Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.
    [Show full text]
  • Companies That Exploit Animals ©2019 Crueltyfreeinvesting.Org Title Stock Exchange Stock Symbol Animal Usage 1-800 FLOWERS.COM, Inc
    Companies That Exploit Animals ©2019 CrueltyFreeInvesting.org Title Stock Exchange Stock Symbol Animal Usage 1-800 FLOWERS.COM, Inc. NASDAQ FLWS Meat/Dairy/Eggs 22nd Century Group, Inc AMEX XXII Animal Testing 3M Company NYSE MMM Animal Testing 500.com Limited NYSE WBAI Entertainment|Tangential A. Schulman, Inc. NASDAQ SHLM Animal Testing ABAXIS, Inc. NASDAQ ABAX Animal Testing ABB Ltd NYSE ABB Tangential Abbott Laboratories NYSE ABT Animal Testing|By-product AbbVie Inc. NYSE ABBV Animal Testing Abeona Therapeutics Inc. NASDAQ ABEO Animal Testing Abercrombie & Fitch Company NYSE ANF Leather/Hide/Fur ABIOMED, Inc. NASDAQ ABMD Animal Testing AC Immune SA NASDAQ ACIU Animal Testing Acacia Research Corporation NASDAQ ACTG Animal Testing ACADIA Pharmaceuticals Inc. NASDAQ ACAD Animal Testing Acasti Pharma, Inc. NASDAQ ACST Animal Testing B&G Foods, Inc. NASDAQ BGS Meat/Dairy/Eggs Balchem Corporation NASDAQ BCPC Animal Testing|By-product|Pet Industry Alexion Pharmaceuticals, Inc. NASDAQ ALXN Animal Testing|Meat/Dairy/Eggs Amazon.com, Inc. NASDAQ AMZN Entertainment|Leather/Hide/Fur|Meat/Dairy/Eggs American Airlines Group, Inc. NASDAQ AAL Meat/Dairy/Eggs Amgen Inc. NASDAQ AMGN Animal Testing Bed Bath & Beyond Inc. NASDAQ BBBY Animal Testing|By-product|Leather/Hide/Fur|Tangential Biogen Inc. NASDAQ BIIB Animal Testing C.H. Robinson Worldwide, Inc. NASDAQ CHRW Meat/Dairy/Eggs|Tangential Celgene Corporation NASDAQ CELG Animal Testing Costco Wholesale Corporation NASDAQ COST Leather/Hide/Fur|Meat/Dairy/Eggs DENTSPLY SIRONA Inc. NASDAQ XRAY Animal Testing Dollar Tree, Inc. NASDAQ DLTR Leather/Hide/Fur|Meat/Dairy/Eggs eBay Inc. NASDAQ EBAY Leather/Hide/Fur|Meat/Dairy/Eggs|Pet Industry Endo International plc NASDAQ ENDP Animal Testing Garmin Ltd.
    [Show full text]
  • Cytrx Corporation (Exact Name of Registrant As Specified in Its Charter)
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) T ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2012 or £ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 0-15327 CytRx Corporation (Exact name of Registrant as specified in its charter) Delaware 58-1642740 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 11726 San Vicente Blvd, Suite 650, Los Angeles, California 90049 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (310) 826-5648 ________________ Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered Common Stock, $0.001 par value per share The NASDAQ Capital Market Series A Junior Participating Preferred Stock Purchase Rights Securities Registered Pursuant to Section 12(g) of the Act: None Indicate by check mark if the Registrant is a well-known seasoned issuer (as defined in Securities Act Rule 405). Yes £ No R Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes £ No T Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]