Cerus Corporation (NASDAQ:CERS) declined to $4.24 per share in the last trading day compared to a prior close of $4.45. The management team hold 1.6 percent of the stock. Corash Laurence M ranks as top insider in Cerus Corporation, noted in the Company’s filings with the U.S. Securities and Exchange Commission. The insider’s stake of 1,319,756 shares is worth $5,595,765. Greenman William Mariner is ranked No.2 with 298,283 shares as of Sep 30, 2016, which sits at a market value around $1,264,720. Green Kevin Dennis is another big name in this category. This insider owns 42,167 CERS shares, amounting to about $178,788 as of recent trading price which is 0.17% above its 20-day moving average and -22.76% below its 50-day moving average. The equity dropped -17.57% over the trailing 3 months.

Cerus Corporation (NASDAQ:CERS) on March 7, 2017 announced financial results for the fourth quarter and year ended December 31, 2016.

Product revenue for the fourth quarter of 2016 was $10.1 million, compared to $9.7 million recognized during the same period in 2015. Revenue for the year ended December 31, 2016, was $37.2 million, compared to $34.2 million for the year ended December 31, 2015. The increase in reported product revenue was primarily driven by a year-over-year increase in demand as U.S. blood banks began to implement our INTERCEPT technology.

Revenue from our BARDA agreement was $1.8 million in the fourth quarter and $2.1 million for the full year 2016. We did not recognize any revenue from our BARDA agreement during the same time periods in 2015.

Looking ahead, the Company expects 2017 global product revenue in the range of $45 million to $50 million, with anticipated product revenue growth contribution from both the U.S. and EMEA markets. INTERCEPT disposable kit revenue is expected to be the primary product growth driver, resulting from anticipated increased penetration in EMEA markets and as U.S. customers who deployed the technology in 2016 move into anticipated routine production and product sales to their hospital customers.

Gross margins on product revenue for the fourth quarter of 2016 were 45%, compared to 36% for the fourth quarter of 2015. Gross margins for the year ended December 31, 2016, were 45%, compared with 31% in the same period in 2015.

Gross margins on product revenue for the full-year 2016 increased due to the favorable impact of the Company’s disposable kit manufacturing agreement with Fresenius Kabi AG, entered into during the fourth quarter of 2015. In addition the Company realized inventory management efficiencies, leading to lower losses and period charges throughout 2016. Looking ahead, the Company expects to achieve relatively stable and consistent gross margins on product sales in 2017 relative to those it experienced in 2016.

Total operating expenses were $21.5 million and $80.4 million for the quarter and year ended December 31, 2016, respectively, compared to $18.5 million and $71.8 million for the quarter and year ended December 31, 2015, respectively.

Selling, general and administrative expenses increased for the three and twelve months ended December 31, 2016. The increase in operating expenses was partially driven by selling, general and administrative expenses incurred in support of the Company’s U.S. commercialization efforts. In addition, research and development costs increased as a result of activities under the Company’s BARDA agreement, preparations for the planned CE mark submission for the Company’s red blood cell system, and U.S. label claim expansion activities.

Operating losses during the fourth quarter of 2016 were $15.1 million, compared to $15.0 million during the fourth quarter of 2015, and $61.4 million compared to $61.1 million for years ended December 31, 2016 and 2015, respectively.

Net loss for the fourth quarter of 2016 was $13.5 million, or $0.13 per diluted share, compared to a net loss of $14.8 million, or $0.15 per diluted share, for the fourth quarter of 2015. Net loss for the year ended December 31, 2016, was $62.9 million, or $0.62 per diluted share, compared to a net loss of $55.9 million, or $0.61 per diluted share, for the same period of 2015.

Net loss for the fourth quarter of 2016 was positively impacted by non-cash income tax benefit of $1.2 million. Net losses for the quarter and year ended December 31, 2015, were positively impacted by non-cash income tax benefits of $1.8 million and $3.8 million. These tax items are largely the result of changes in the fair value of our investments, primarily Aduro Biotech, Inc.

Net loss for the fourth quarter of 2015 was also negatively impacted by the mark-to-market adjustments of the Company’s previously outstanding warrants, which resulted in non-cash losses of $1.1 million during the quarter ended December 31, 2015. Net loss for the year ended 2015 was positively impacted by the mark-to-market adjustments of the Company’s previously outstanding warrants, which resulted in non-cash gains of $3.6 million. At December 31, 2016, the Company has no remaining outstanding warrants and as such, does not expect mark-to-market adjustments going forward.

Tesaro, Inc. (NASDAQ:TSRO) shares closed at $171.84, down -1.46 points or -0.84 percent from  the previous close price. The up to date insider trading filings show V.P. of Finance & Admin. English Edward C has disposed of 10,000 shares,reducing the ownership to 396 units. The transaction occurred on Mar 06, 2017, at $178.06 per share worth a total $1,780,600. There was another major transaction on the insider-trading front. PEARSON TIMOTHY R, Exec. VP, CFO at TSRO bought 1,447 common shares at a per share price of $177.61 to hold 2,928 shares. The stock recently traded at a volume of 0 shares vs. an average volume of 871.39K. The latest closing price is now higher 30.64% for the past quarter. The price is now 5.07% above its 50-day moving average and 50.1% above its 200-day moving average. The percentage change return over the last fifty two weeks remained 297.5%. The price range in the same period had a highest hit of $192.94 while lowest level in that period was $36.68.

Tesaro, Inc. (NASDAQ:TSRO) on March 13, 2017 announced the presentation of secondary endpoint results from the Phase 3 ENGOT-OV16/NOVA trial of niraparib at the 2017 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, March 12 to 15, 2017 by Dr. Sven Mahner, M.D., Director, Department of Gynecology and Obstetrics, University of Munich.

“The results of several secondary endpoints from the ENGOT-OV16/NOVA trial, including chemotherapy-free interval (CFI), time to second subsequent therapy (TSST), and progression-free survival 2 (PFS-2), demonstrate the positive and durable treatment effect of niraparib in a broad population of patients with ovarian cancer, regardless of germline BRCA mutation status,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO.  “An assessment of progression-free survival in patients who have progressed on treatment received after completing the NOVA study treatment (PFS-2) compared to their first progression while on the NOVA study (PFS) indicates that niraparib does not decrease the benefit of subsequent treatment.”

Niraparib is the only PARP inhibitor that has shown a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial.

Secondary Endpoint Results:
Niraparib Significantly Improved Chemotherapy-free Interval (CFI) 
Among patients who were germline BRCA mutation (gBRCAmut) carriers, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of CFI, with a hazard ratio of 0.26 (95% CI, 0.166-0.409). The median CFI for patients treated with niraparib was 22.8 months, compared to 9.4 months for control (p<0.0001).

Among patients without germline BRCA mutations (non-gBRCAmut), the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of CFI, with a hazard ratio of 0.50 (95% CI, 0.370-0.666). The median CFI for patients treated with niraparib was 12.7 months, compared to 8.6 months for control (p<0.0001).

Niraparib Significantly Improved Time to First Subsequent Treatment (TFST) 
Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of TFST, with a hazard ratio of 0.31 (95% CI, 0.205-0.481). The median TFST for patients treated with niraparib was 21.0 months, compared to 8.4 months for control (p<0.0001).

Among patients without germline BRCA mutations, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of TFST, with a hazard ratio of 0.55 (95% CI, 0.412-0.721). The median TFST for patients treated with niraparib was 11.8 months, compared to 7.2 months for control (p<0.0001).

Niraparib Had No Impact on the Efficacy of Next-Line Therapy
For a pooled group of patients who have progressed on subsequent therapy (including patients with germline BRCA mutations and without germline BRCA mutations), each patient’s initial progression-free survival interval was subtracted from the progression-free survival 2 interval, which showed no reduction in benefit of niraparib treatment on the effectiveness of subsequent chemotherapy, with a hazard ratio of 1.02 (95% CI, 0.765-1.349). In the NOVA study, a HR of 1.0 demonstrates that the impact of niraparib on efficacy of the subsequent therapy was clinically indistinguishable from the impact of placebo control on the efficacy of the subsequent therapy.

Progression-free Surivival-2 and Overall Survival are Immature, but Favor Niraparib
PFS-2 data were statistically significant and favored niraparib over control for patients in both the gBRCAmut cohort (HR 0.48; 95% CI, 0.242-0.687) and non-gBRCAmut cohort (HR 0.69; 95% CI, 0.494-0.964). Given the relatively long PFS patients experienced on niraparib, PFS-2 was immature, with only 30% of events captured for patients in the gBRCAmut cohort and only 50% of events captured for patients in the non-gBRCAmut cohort. Data for overall survival were also immature (HR 0.73; 95% CI, 0.480 to 1.125; p=0.1545), as fewer than 20% of events had occurred at the time of analysis.

Phase 3 ENGOT-OV16/NOVA Trial Results 
The ENGOT-OV16/NOVA trial is an international Phase 3, double-blind, placebo-controlled study that enrolled 553 patients with recurrent ovarian cancer who had achieved either a partial or complete response (PR or CR) to their most recent platinum-based chemotherapy. Niraparib significantly increased PFS in patients with and without germline BRCA mutations as compared to control, and the magnitude of benefit was similar for patients entering the trial with a PR or a CR. Results also showed that treatment with niraparib reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). Niraparib is the only PARP inhibitor that has shown a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial.

The most common grade 3/4 adverse reactions to niraparib in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were managed via dose modification. Discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively.