| Previous Close | 54.98 |
| Open | 55.20 |
| Bid | 59.00 x 900 |
| Ask | 58.99 x 800 |
| Day's Range | 55.04 - 58.93 |
| 52 Week Range | 7.61 - 65.43 |
| Volume | 700,044 |
| Avg. Volume | 577,276 |
| Market Cap | 4.051B |
| Beta (5Y Monthly) | 1.68 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | N/A |
| Earnings Date | N/A |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | N/A |
- GlobeNewswire
ChemoCentryx Announces FDA Acceptance of the Avacopan New Drug Application (NDA) for the Treatment of ANCA-Associated Vasculitis
\-- FDA sets PDUFA goal date of July 7, 2021 --MOUNTAIN VIEW, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set July 7, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA. Avacopan is a first-in-class, orally administered therapy that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis. In its NDA acceptance letter, the FDA also indicated that it may, but has not yet determined whether to hold an advisory committee meeting to discuss the application per guidelines for new molecular entities.The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group. Finally, avacopan demonstrated favorable safety results, with fewer patients having serious adverse events in the avacopan group than in the prednisone group.About ADVOCATE and ANCA-Associated Vasculitis The ADVOCATE trial of avacopan was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive avacopan plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) or prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate).ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.About Avacopan Avacopan is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Current therapies for ANCA-associated vasculitis and other related illnesses typically include broad immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. Avacopan therapy was designed to prevent these outcomes. Moreover, avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G.ChemoCentryx is responsible for the discovery and development of avacopan and owns and retains the commercial rights to the drug in the United States. ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan in markets outside of the U.S.About ChemoCentryx ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis.ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.Forward-Looking Statements ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding the timing of anticipated PDUFA date, or whether the FDA will hold an advisory committee meeting for the avacopan NDA for the treatment of ANCA-associated vasculitis, the achievement of anticipated goals and milestones, whether avacopan will be approved by the FDA for the treatment of ANCA-associated vasculitis, whether avacopan will be an effective treatment in other indications such as C3G or HS, and whether the Company's drug candidates will be shown to be effective in ongoing or future clinical trials. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC on March 10, 2020 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.Contacts:Susan M. Kanaya Executive Vice President, Chief Financial and Administrative Officer investor@chemocentryx.comMedia: Stephanie Tomei 408.234.1279 media@chemocentryx.comInvestors: Burns McClellan, Inc. Steve Klass 212.213.0006 sklass@burnsmc.com
- GlobeNewswire
ChemoCentryx to Present at the H.C. Wainwright 22nd Annual Global Investment Conference
MOUNTAIN VIEW, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 p.m. ET. A live audio webcast of the presentation can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company's website for two weeks following the live presentation.About ChemoCentryxChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered, targeted therapies. ChemoCentryx’s lead drug candidate, avacopan, completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application (NDA) has been submitted to the FDA. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The Company also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer, including an orally-administered small molecule checkpoint inhibitor of PD-1/PD-L1. For more information, please visit www.chemocentryx.comContacts:Susan M. Kanaya Executive Vice President, Chief Financial and Administrative Officer investor@chemocentryx.com Media: Stephanie Tomei 408.234.1279 media@chemocentryx.comInvestors: Steven Klass, Burns McClellan 212.213.0006 Sklass@burnsmc.com
- GlobeNewswire
ChemoCentryx Reports Second Quarter 2020 Financial Results and Recent Highlights
\-- U.S. New Drug Application (NDA) submitted for avacopan in ANCA-associated vasculitis --\-- Balance sheet bolstered with $325.7 million in net proceeds from June follow-on offering; total cash, cash equivalents and investments greater than $500 million at end of Q2 --\-- Topline data from AURORA trial in Hidradenitis Suppurativa (HS) expected early Q4; C3 Glomerulopathy (C3G) ACCOLADE trial topline data YE 2020 --\-- Novel orally administered checkpoint inhibitor CCX559 for next generation cancer treatment to enter clinical development in H1 2021 --\-- Conference call today at 5:00 p.m. Eastern Time --MOUNTAIN VIEW, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq: CCXI) today announced financial results for the second quarter ended June 30, 2020 and provided an overview of the Company's recent corporate highlights."A major milestone was accomplished recently with the filing of the NDA for avacopan for the treatment of ANCA-associated vasculitis with the U.S. FDA,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “This is one more crucial step toward achieving our unwavering goal of changing the treatment paradigm for people now enduring this organ-threatening and life-endangering disease. ANCA vasculitis patients have waited too long for new therapy; it is our goal to make sure that wait is not in vain.” “We are also ever closer to realizing avacopan’s potential as a pipeline-in-a-drug with upcoming readouts in HS and C3G expected later this year. We will not stop there. The innovation seen in such new pipeline assets as CCX559, our novel orally administered checkpoint inhibitor for next generation cancer treatment, has real potential to fuel future growth and create significant value. I believe that we are poised to achieve our ultimate mission to be a fully integrated and self-sustaining enterprise that provides better therapies for previously neglected, underserved patient needs. And the $325.7 million in net proceeds from our successful June equity follow-on offering, coupled with our already healthy cash reserves, provides the capital to get us there.”Key Highlights * Filed the New Drug Application (NDA) for avacopan in the treatment of ANCA-associated vasculitis in July. The Company’s NDA submission is supported by the results of its pivotal Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group. Finally, avacopan demonstrated favorable safety results in this serious and life-threatening disease, with fewer subjects having serious adverse events in the avacopan group than in the prednisone group. * Presented additional data from the ADVOCATE trial were selected for oral plenary presentations in June at the leading European rheumatology and nephrology conferences: EULAR (European League Against Rheumatism) and ERA-EDTA (European Renal Association - European Dialysis and Transplant Association). * Presented data at the American Association for Cancer Research (AACR) meeting in June, demonstrating that the Company’s orally administered checkpoint inhibitors led to marked inhibition of PD-1/PD-L1 interaction and signaling in vitro and potent anti-tumor effects in animal models. The Company has identified its orally administered checkpoint inhibitor, CCX559, as a candidate for next generation cancer treatment and plans to initiate clinical studies in the first half of 2021. * Completed enrollment in May 2020 of more than 400 patients in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA are now expected early in the fourth quarter of 2020, a modest delay caused by the resurgence of COVID-19 impacting certain sites where we have been conducting this trial. * Strengthened the balance sheet with $325.7 million in net proceeds from a successful equity follow-on offering, including full exercise of the underwriters’ option to purchase additional shares. Proceeds from the offering will be used to support the anticipated commercial launch of avacopan in ANCA vasculitis; avacopan lifecycle management, including expansion into additional indications and formulation development; and development of additional drug candidates, including CCX559. * Reported cash, cash equivalents and investments exceeded $504.6 million at June 30, 2020.Second Quarter 2020 Financial ResultsRevenue was $49.4 million for the second quarter of 2020, compared to $7.2 million for the same period in 2019. The increase in total revenue from 2019 to 2020 was primarily due to the acceleration of revenue recognition associated with the CCX140 agreement with Vifor. Following the decision to discontinue development of CCX140 in FSGS, $46.7 million of deferred revenue was recognized as contract revenue. This increase was partially offset by lower costs incurred due to the completion of the avacopan ADVOCATE Phase III pivotal trial in 2020.Research and development expenses were $18.8 million for the second quarter of 2020, compared to $17.6 million for the same period in 2019. The increase from 2019 to 2020 was primarily attributable to the completion of patient enrollment of the avacopan AURORA Phase IIb clinical trial in patients with HS, professional fees associated with the preparation of our NDA submission for avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those tied to the advancement of CCX559, the Company’s orally administered checkpoint inhibitor. These increases were partially offset by lower expenses due to the completion of the avacopan ADVOCATE Phase III pivotal trial in 2020 and the CCX140 LUMINA-1 Phase II clinical trial in 2019.General and administrative expenses were $10.3 million for the second quarter of 2020, compared to $5.6 million for the same period in 2019. The increase from 2019 to 2020 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees. Net income for the second quarter of 2020 was $20.3 million, compared to net loss of $15.2 million for the same period in 2019.Total shares outstanding at June 30, 2020 were approximately 68.8 million shares.Cash, cash equivalents and investments totaled $504.6 million at June 30, 2020, including the $325.7 million in net proceeds from the June 2020 equity follow-on offering of common stock.Conference Call and WebcastThe Company will host a conference call and webcast today, August 10, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 6246545. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the conference call.About ChemoCentryxChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis.ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.Forward-Looking Statements ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding the timing of the FDA’s filing decision for the Company’s NDA, the achievement of anticipated goals and milestones, whether avacopan will be approved by the FDA for the treatment of ANCA-associated vasculitis, whether avacopan will be an effective treatment in other indications such as C3G or HS, when full data analysis of LUMINA-1 and topline LUMINA-2, AURORA and ACCOLADE clinical data might become available or be released, whether CCX559 will enter clinical trials in the first half of 2021, and whether the Company's drug candidates will be shown to be effective in ongoing or future clinical trials. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC on March 10, 2020 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.Contacts:Susan M. Kanaya Executive Vice President, Chief Financial and Administrative Officer investor@chemocentryx.comMedia: Stephanie Tomei 408.234.1279 media@chemocentryx.comInvestors: William Slattery, Jr., Burns McClellan 212.213.0006 bslattery@burnsmc.com ChemoCentryx, Inc. Condensed Consolidated Financial Statements Data (in thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 (unaudited) Condensed Consolidated Statements of Operations Data: Revenue: Collaboration and license revenue from related party$49,283 $7,173 $55,138 $15,500 Grant revenue 157 - 310 - Total revenue 49,440 7,173 55,448 15,500 Operating expenses: Research and development 18,762 17,624 38,073 32,978 General and administrative 10,292 5,570 19,112 11,071 Total operating expenses 29,054 23,194 57,185 44,049 Income (loss) from operations 20,386 (16,021) (1,737) (28,549) Total other income (loss), net (119) 871 317 1,450 Net income (loss)$20,267 $(15,150) $(1,420) $(27,099) Net income (loss) per common share: Basic$0.32 $(0.26) $(0.02) $(0.49) Diluted$0.29 $(0.26) $(0.02) $(0.49) Shares used to compute net income (loss) per common share: Basic 63,282 58,056 62,289 55,226 Diluted 69,416 58,056 62,289 55,226 June 30, December 31, 2020 2019 (unaudited) Condensed Consolidated Balance Sheets Data: Cash, cash equivalents and investments $504,620 $202,240 Working capital 450,868 115,282 Total assets 542,044 209,083 Long-term debt, net 24,252 19,786 Accumulated deficit (431,406) (429,986) Total stockholders’ equity 421,141 66,000
