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Mark Your Calendar For TCON, XLRN, Xenon Lights Up, MACK Gets Going

Pharma 022015

Acceleron Pharma Inc. (XLRN) will be presenting new preliminary data from an ongoing phase 2 clinical trial of Dalantercept in patients with advanced renal cell carcinoma, dubbed DART, on February 28, 2015.

XLRN closed Thursday's trading 5.25% higher at $40.52.

Eli Lilly and Co. (LLY) has decided to extend its phase III trial of its drug candidate Evacetrapib in patients at a high risk for vascular outcomes by approximately six months. A futility analysis of the trial, which was previously anticipated in Q1 2015, is now expected to occur in Q3 2015.

LLY closed Thursday's trading at $71.12, up 0.15%.

Immunomedics Inc. (IMMU), while presenting updated results from a phase II study of Sacituzumab govitecan, announced that 33% of patients with small cell lung cancer and 31% with non-small cell lung cancer had their tumor reduced in size by 30% or more.
Including patients that reported stable disease as their best response, the drug candidate controls the progression of the cancer in 75% and 56% of NSCLC and SCLC patients, respectively, noted the company.

The analysis was based on 16 patients with SCLC and 18 with NSCLC. A total of 44 heavily-pretreated patients with relapsed or refractory lung cancer have been enrolled in the study.

IMMU closed Thursday's trading at $4.02, up 0.25%.

Merrimack Pharmaceuticals Inc. (MACK) has initiated a global, randomized phase 2 clinical trial of its drug candidate MM-121, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer.

The trial is designed to enrol approximately 120 heregulin positive patients. The primary endpoint of the trial is progression free survival. Secondary endpoints include overall survival, objective response rate, safety and tolerability.

MACK closed Thursday's trading 1.95% higher at $11.00.

Northwest Biotherapeutics' (NWBO) ongoing phase III clinical trial of DCVax-L for Glioblastoma multiforme brain cancer has been approved by Health Canada to proceed in Canada.

The approval process at two sites has been completed and screening for enrolment is underway, said the company.

NWBO closed Thursday's trading 2.25% higher at $6.37.

Sagent Pharmaceuticals Inc. (SGNT) reported record revenue and strong earnings results in the fourth quarter ended December 31, 2014.

Net income for the fourth quarter of 2014 surged to $30.0 million or $0.91 per share on revenue of $84.4 million. This compared with a net income of $3.6 million or $0.11 per share and revenue of $64 million in the year-ago quarter.

Looking ahead to fiscal 2015, the company expects net revenue to be in the range of $325 to $375 million. The net revenue in 2014 was $289.8 million.

SGNT closed Thursday's trading at $28.50, up 3.45%.

TRACON Pharmaceuticals (TCON), which had its IPO as recently as January 30, 2015, is scheduled to present results from a phase Ib dose-escalation study of TRC105 in combination with Pfizer's Inlyta in patients with metastatic renal cell carcinoma on February 28, 2015.

Inlyta is approved by the FDA for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

TCON closed Thursday's trading at $9.97, down 2.25%.

Shares of Xenon Pharmaceuticals Inc. (XENE) rose 14% on Thursday after the company announced that its development and commercialization partner Teva Pharmaceutical Industries Ltd. (TEVA) will initiate a phase 2b clinical trial of TV-45070 in patients with post-herpetic neuralgia, or PHN.

The phase 2b clinical trial in PHN is designed to enrol approximately 330 patients, and the first patient is anticipated to be dosed next month.

Another Phase 2b clinical trial of TV-45070 is ongoing, and that is in the indication of osteoarthritis for which data are expected in the third quarter of this year.

Xenon Pharma went public on the NASDAQ Global Market on November 5, 2014, priced at $9 per share.

XENE closed Thursday's trading 14.31% higher at $19.65.

XenoPort Inc. (XNPT) has reported a narrower loss on 144% revenue growth for the fourth quarter ended December 31, 2014.

Net loss for Q4, 2014 shrunk to $17.7 million or $0.28 per share on total revenue of $7.1 million. This compared with a net loss of $19.1 million or $0.40 per share and total revenue of $2.9 million in the year-ago quarter.

Net product sales from HORIZANT (gabapentin enacarbil) Extended-Release Tablets, which account for a major portion of the company's revenue, were up 143% to $6.6 million in Q4, 2014 compared to Q4, 2013.

Looking ahead to 2015, XenoPort expects HORIZANT net product sales to be in the range of $39.0 million to $43.0 million.

XNPT closed Thursday's trading at $6.89, up 0.73%. In after-hours, the stock was up another 3.92% at $7.16.

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