ArQule Is Undervalued Going Into Catalyst Events
Clinically Sound Investor
Clinically Sound Investor
Mon, Nov. 7, 7:11 AM
Sun, Nov. 6, 5:30 PM| Sun, Nov. 6, 5:30 PM | 5 Comments
Wed, Aug. 3, 10:11 AM
Wed, Aug. 3, 7:01 AM
Tue, Aug. 2, 5:30 PM
- AAWW, AFAM, ALE, APO, ARCC, ARCO, ARQL, ATHM, ATRO, AVA, CDK, CDW, CEVA, CLDT, CLH, CLX, CRL, CROX, CRTO, CSTE, CWEI, D, DDD, DIN, DLPH, DM, DNOW, DOC, EE, ENR, FCPT, FUN, GEL, HFC, HUM, HYH, ICE, ING, INSY, INXN, IRT, KATE, KLIC, LINC, LMOS, MDC, MEMP, MFA, MTOR, NBL, NSM, NVMI, ODP, ORBK, OXY, PERI, POR, RRD, SBGI, SC, SCMP, SE, SHOP, SMG, SMP, SPR, SR, SUM, TMHC, TWX, USAK, VER, VIRT, VOYA, VSI, WD, XEL, ZTS
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
- ArQule (NASDAQ:ARQL): Q1 EPS of -$0.08 misses by $0.01.
- Revenue of $1.23M (-55.8% Y/Y) misses by $0.4M.
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
- ArQule (NASDAQ:ARQL): Q4 EPS of -$0.05 beats by $0.01.
- Revenue of $2.8M (-7.3% Y/Y) beats by $0.25M.
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.