A Close Look At ArQule
Prescient Investment Analysis
Prescient Investment Analysis
Thu, Jun. 30, 9:16 AM
Thu, Jun. 30, 8:52 AM
- Preliminary data from ArQule's (NASDAQ:ARQL) ongoing Phase 1/2 clinical trial assessing dual kinase inhibitor ARQ 087 in intrahepatic cholangiocarcinoma showed evidence of effect, measured by objective response rate and disease control rate, in patients with mutations in the fibroblast growth factor receptor 2 (FGFR2) gene. The results were presented a the ESMO 18th World Congress on Gastrointestinal Cancer in Barcelona.
- 14 of the 21 patients in the study dosed with ARQ 087 were FGFR2 mutation-positive. 12 of the 14 were evaluable. In this group of 12, the objective response rate was 25% (n=3/12) (three partial responders) and the disease control rate was 75% (n=9/12) (three partial responders + six with stable disease). Three patients progressed after treatment.
- The study should be completed in Q3.
- Shares are up 10% premarket on increased volume.
Wed, Jun. 1, 11:00 AM
Wed, May 4, 7:01 AM
Tue, May 3, 5:30 PM
- AFAM, ARCC, ARCO, ARQL, ASC, ATRO, AVA, AYR, BDC, BUD, CDW, CHH, CLH, CPK, CRK, CRL, CRTO, CRZO, CSTE, D, DLPH, DNOW, ECYT, EE, ENR, FUN, GEL, GNRC, GTE, HAIN, HE, HFC, HSC, HSNI, HTWR, HYH, ICE, INXN, IONS, IRT, KATE, KLIC, LGND, MEMP, MFA, MMP, MOS, MPW, MTOR, NBL, NGS, NJR, NRZ, NVMI, NXTM, OMF, ONCE, ORBK, PCG, PCLN, RDC, RDS.A, SBGI, SCMP, SE, SERV, SHOP, SMP, SPAR, SR, SRE, SSTK, STRA, TGH, TGI, TMHC, TREE, TWX, VIRT, VOYA, VSI, WD, WIX, ZTS
Mon, Feb. 29, 8:40 AM
- ArQule (NASDAQ:ARQL) enters into agreements with institutional and accredited investors for the direct placement of 8,027,900 shares of common stock at $1.90 per share ($15.3M). Each share includes a 12-month option to purchase ~0.4444 of a share of common stock at $2.50. Closing date is March 2.
- Net proceeds of ~$15.2M will fund the clinical development of pipeline candidates, preclinical research of its BTK inhibitor program and general corporate purposes.
- Friday's close was $1.98.
Mon, Feb. 29, 7:03 AM
Sun, Feb. 28, 5:30 PM
Nov. 4, 2015, 7:01 AM
- ArQule (NASDAQ:ARQL): Q3 EPS of -$0.04 beats by $0.04.
- Revenue of $2.65M (-0.4% Y/Y) beats by $0.05M.
Nov. 3, 2015, 5:30 PM
- AFAM, AGN, AMRN, ARCC, ARCO, ARQL, ARRY, AVA, AVP, AXAS, BDX, BIOS, BSFT, CBB, CDW, CECO, CHK, CLH, CRK, CRL, CRTO, CRZO, CST, CSTE, CTSH, DAVE, DDD, EE, EMES, FOR, FOXA, GDP, HAE, HEP, HMC, HSIC, HSNI, INXN, KELYA, KORS, LINC, LL, MEMP, MFA, MNTA, MSI, MWE, NAVB, NCT, NEWP, NRG, NYLD, REGN, SBGI, SCMP, SE, SHOP, SNH, SODA, SSYS, STNG, TESO, TMHC, TWX, USAK, VG, VOYA, VRTU, VSI, WCG, WD, WEC, WEN, WILN, WIX, WMC
Nov. 3, 2015, 8:19 AM
- In a regulatory filing, ArQule (NASDAQ:ARQL) discloses that it has exercised its option with development and commercialization partner Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) to co-commercialize lead product candidate tivantinib in the U.S. as allowed under their December 2008 Agreement (subject to FDA approval). A separate co-commercialization agreement should be inked in Q1.
- Tivantinib is currently being evaluated in a Phase 3 study, METIV-HCC, as second line treatment of liver cancer [hepatocellular carcinoma (HCC)]. The primary endpoint is overall survival. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is March 2017. The estimated study completion date is June 2017.
- If METIV-HCC is successful and tivantinib is cleared by the FDA, ArQule will receive $55M in milestone payments for the official acceptance of its marketing applications in the U.S. and EU. for the second line treatment of HCC. It will earn an additional $100M in combined milestones based on FDA clearance and the first commercial sale in the UK, Germany, France, Italy or Spain. The total milestone payments of $155M will partially offset the $75M - 85M that ArQule owes Daiichi for the costs of the Phase 3 trial. ArQule also expects to earn sales-based royalties of 20%.
- Tivantinib is an orally-administered selective inhibitor of MET, a receptor of tyrosine kinase.
Aug. 5, 2015, 7:15 AM
- ArQule (NASDAQ:ARQL): Q2 EPS of -$0.06 beats by $0.02.
- Revenue of $3M (+3.4% Y/Y) beats by $0.5M.
Aug. 4, 2015, 5:30 PM
- AMSC, ANSS, ARIA, ARQL, ATHM, ATRO, AVA, AVT, BLT, CEQP, CHK, CLDT, CLH, CMLP, CONE, CRK, CRME, CSTE, CSTM, CTSH, D, DAVE, DISCA, DISH, DNOW, DNR, EE, ENBL, FI, GDP, GTN, HCA, HFC, HSC, ICE, INXN, KATE, KELYA, KERX, LDOS, LG, LINC, LIOX, LL, LPLA, MEMP, MSI, MSO, MWE, PCLN, PWR, RDC, RL, SALE, SBGI, SCMP, SE, SNAK, SODA, SPAR, SPB, SUP, TMHC, TWX, USAC, VC, VLP, VOYA, VSI, WCG, WD, WEN, WIX
Jul. 6, 2015, 10:08 AM
- An interim analysis of a Phase 2 study assessing ArQule's (ARQL -3.1%) lead product candidate, tivantinib, in combination with Erbitux (cetuximab), in patients with MET-High, KRAS wild-type metastatic colorectal cancer who recently progressed on anti-EGFR therapies showed a 52.4% disease control rate (DCR). The data were presented at the European Society of Medical Oncology World GI 2015 meeting in Milan, Italy.
- In 21 patients enrolled in the first stage of the trial, one experienced a complete response (CR), two experienced durable partial responses (PRs) and eight showed stable disease (SD). The DCR was, therefore, 52.4% (n=11/21). 20 additional patients were enrolled in the second stage.
- The primary endpoint of the trial is objective response rate (ORR) in the biomarker defined population. ORR frequently correlates with overall survival (OS) benefit.
- Final results from the complete 41-patient study are expected by the end of the year.
- Related tickers: (BMY +0.2%)(LLY -0.2%)
Jun. 1, 2015, 1:22 PM
May 6, 2015, 8:27 AM
- ArQule (ARQL -3.4%) Q1 results: Revenues: $2.8M (+3.7%); R&D Expense: $4.4M (-34.3%); SG&A: $3.2M (-3.0%); Operating Loss: ($4.8M) (+34.2%); Net Loss: ($4.6M) (+35.2%); Loss Per Share: ($0.07) (+36.4%); Quick Assets: $53.6M (-9.5%).
- No guidance given.
ArQule, Inc. is a clinical-stage biotechnology company that is engaged in the research and development of cancer therapeutics. Its products and research programs focuses on key biological processes that are central to human cancers. The company's programs also include research and development,... More
Country: United States
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