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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 PMArQule says it's received a letter from the FDA recommending lower dosages of its liver cancer treatment
- 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.
Mar. 12, 2013, 5:48 PM
Jan. 31, 2013, 11:40 AMShares of ArQule (ARQL +2.4%) move up after the company says it's enrolled the first patient in its Phase 3 trial of tivantinib, which is being evaluated for the treatment of patients diagnosed with hepatocellular carcinoma who have received one or two prior systemic anti-cancer therapies. The company expects to enroll about 300 patients at approximately 120 clinical centers worldwide. | Comment!
Jan. 16, 2013, 5:41 PM
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