Tag: Ovarian cancer

Clovis Oncology Stock Rising Off Uptrend Channel Line

Clovis Oncology stock is rising off its uptrend channel line as large players volume continues to rise. The uptrend is also supported by the Twiggs Money Flow which is slowly rising. I dipped my toe in the water and purchased a little bit of Clovis Oncology stock today.

Clovis Oncology News

Since the company reported earnings on August 2, 2017, Clovis Oncology shares have lost about -8%. Clovis reported a second-quarter 2017 loss of -$1.29 per share, which was narrower than the year-ago loss of -$2.07 per share. The reported loss was greater than analysts forecast of -$1.27.

Net product revenues, entirely from Rubraca, were approximately $14.6 million in the quarter, up 108.6% sequentially. Revenues beat the consensus estimate of $12.54 million. The company said that 750 new patients were registered in the quarter.

Clovis Oncology’s Rubraca has shown an impressive growth trend in 2017. The drug received accelerated approval in Dec 2016. Rubraca is a PARP inhibitor, which is approved as a monotherapy for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. Rubraca has had an almost 100% growth in sales sequentially in the second quarter of 2017. Rubraca sales were $21.7 million in the first half of 2017. The company had 1100 new patients on therapy in the period.

Two confirmatory studies – ARIEL-3 and ARIEL-4 – are being conducted by Clovis for converting the accelerated approval to continued approval of Rubraca. The company’s shares got a boost when it announced positive top-line results from ARIEL 3 in June 2017. Progression-free survival (PFS) and safety results from the ARIEL-3 study demonstrated that Rubraca had a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. Clovis is planning to file a supplemental new drug application (sNDA) to the FDA by October this year based on ARIEL-3 data to include second-line or later maintenance indication for advanced ovarian cancer on the label of Rubraca. The company expects the label expansion to increase patient population by at least four times.

Rubraca is under review in the EU for a comparable ovarian cancer indication. An approval is expected from the EU in the first quarter of 2018.

I’m hearing rumors circulating that Clovis Oncology could be a takeover candidate by the end of the year because of Rubraca and the fact that Gilead bought KITE at the end of August.

You can find out more about Clovis Oncology here.

Clovis Oncology Stock Price

Clovis Oncology stock

Clovis Oncology stock usually swings higher at this time of year according to a seasonality study. Clovis Oncology stock is rising nicely off its uptrend line. The Effective Volume study shows large players volume rising. The Twiggs Money Flow is also rising which supports the thesis that large players are accumulating Clovis Oncology stock. I explain a lot of these chart patterns on the Frequently Asked Questions page here.

CLVS does present a good setup opportunity. Prices have been consolidating lately. There is a support zone below the current price at $72.66, a stop order could be placed below this zone.

Sell Immunogen For an Incredible 101% Win

May 7, 2017: Sell Immunogen for a 101% win in 85 days and congratulations if you made money on the trade.

April 19, 2017: Immunogen’s stock popped 13% today on an upgrade from Leerink Partners. Leerink Partners raised Immunogen to an Outperform rating, from Market Perform, and set a price target of $8. Leerink Partners is upgrading Immunogen based on their higher level of conviction on lead asset mirvetuximab soravtansine providing an attractive risk/reward in context of the stock’s current valuation.

January 2, 2017: Biotechnology firm Immunogen announced that results from the Phase 1 expansion cohort evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology. The data demonstrate the potential clinical benefit of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer.

Immunogen said, “Standard single-agent therapy for patients with platinum-resistant ovarian cancer typically has a response rate below 20% and median progression-free survival below four months. Mirvetuximab soravtansine generated encouraging efficacy and tolerability data in the Phase 1 trial that suggest the potential to improve clinical outcomes for this patient population.”

The Phase 1 expansion cohort enrolled 46 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors were positive for FRa. Patients were dosed with mirvetuximab soravtansine once every three weeks. Mirvetuximab soravtansine demonstrated single-agent activity in the 46-patient cohort with a 26% confirmed response rate and median progression free survival (PFS) of 4.8 months. In a subset of 23 patients with low, medium or high FRa, who had received three or fewer prior lines of therapy, there was a 39% objective response rate (ORR) and median PFS of 6.7 months. On the basis of the study findings and additional data demonstrating the importance of FRa expression levels with mirvetuximab soravtansine, the Company has designed the Phase 3 FORWARD I study to enroll patients with platinum-resistant ovarian cancer with one to three prior therapies and with medium or high FRa. This group of patients in the Phase 1 expansion cohort exhibited a 44% ORR and a median PFS of 6.7 months.

Mirvetuximab soravtansine exhibited a manageable safety profile. Adverse events (AEs) were generally mild with the majority being grade 1 or grade 2 (least severe grades). The most commonly observed AEs were diarrhea, blurred vision, nausea, and fatigue.

Immunogen said, “These results demonstrate that mirvetuximab soravtansine is active in platinum-resistant ovarian cancer, with encouraging response rates and progression-free survival combined with a manageable safety profile. On the basis of these findings, we have moved confidently into a Phase 3 registration study evaluating this promising agent against the standard of care in the platinum-resistant setting. In addition, we are evaluating combination regimens to assess mirvetuximab soravtansine in expanded patient populations and will begin reporting data from these combinations in mid-2017.”

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells.