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
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Jan. 16, 2014, 4:28 PM
- The DMC of ArQule's (ARQL) Phase III METIV-HCC trial in hepatocellular carcinoma recommends the continuation of the trial following a review of the data.
- The data analyses among patients treated with 120 mg BID tivantinib tablets showed a reduced incidence of neutropenia.
- Analyses also demonstrated that plasma exposure of the lower dose was comparable to that achieved with the 240 mg capsules employed in the Phase II trial.
- ARQL +48.3% AH
Sep. 30, 2013, 2:46 PM
- As expected, ArQule (ARQL -7.4%) presented MARQUEE data over the weekend at ECC and thanks (at least in part) to RBC's Adnan Butt and Reuters, investors had high hopes that new information would lead to a second chance for tivantinib in NSCLC. (see original Reuters article)
- Judging by today's market reaction, investors were underwhelmed (or just taking profits after Friday's rally).
- MARQUEE was halted last fall after it became apparent that the study was unlikely to meet the OS primary endpoint.
- However, the data presented over the weekend appears to show a PFS benefit (secondary endpoint): "In the ITT population of 1048 patients ... median PFS was 3.6 months in the treatment arm versus 1.9 months in the control arm."
- Hazard ratio was 0.74 compared to 0.98 for OS. (PR)
Sep. 27, 2013, 1:14 PM
- Today's rally in shares of ArQule (ARQL +9.7%) is likely attributable to RBC's Adnan Butt, who Reuters quotes as saying that an upcoming presentation at ESMO could mean another shot for tivantinib in lung cancer.
- The drug was effectively left for dead (at least as far as NSCLC goes) last October when ARQL and partner Daiichi Sankyo (DSKYF.PK) dropped a Phase 3 trial due to lack of efficacy.
- New data from that trial "could validate the mechanism of action for the drug and potentially allow a path forward in lung cancer as well," Butt says.
Sep. 27, 2013, 12:45 PM
Sep. 27, 2013, 9:15 AM
Sep. 3, 2013, 12:46 PM
Sep. 3, 2013, 12:15 PM
- ArQule (ARQL -7.2%) slides after saying it's received a letter from the FDA's Data Monitoring Committee, which is overseeing Phase III trials of its potential liver-cancer treatment, tivantinib, recommending reduced dosages due to a higher incidence of neutropenia than in earlier trials.
- The letter says the study dosage should be reduced from 240 milligrams twice daily to 120 milligrams, also saying the companies should revise its patient monitoring procedures to confirm the safety of the lower dose.
- ARQL is developing the drug jointly with Daiichi Sankyo.
Sep. 3, 2013, 9:12 AM
Jul. 30, 2013, 3:14 PM
- ArQule (ARQL +1.4%) after its Q2 report beat across the board as losses were mitigated by reduced operational costs and personnel reductions.
- R&D costs declined Y/Y, due to lower outsourced clinical and product development costs related to Phase 1 and Phase 2 programs for tivantinib and pipeline programs, as well as reduced labor-related costs.
- Looking forward, the company sees FY2013 sales of between $12M - 15M.
ArQule, Inc. is a biopharmaceutical company, which engages in the research and development of innovative therapeutics to treat cancers and rare diseases. The company discovers, develops and commercializes novel small molecule drugs that will dramatically extend and improve the lives of patients... More
Country: United States