BABY Makes Big Leap, RIGL's Trial Flops, CLSN Warming Up To HEAT, NPSP On Watch

(RTTNews) - Celsion Corp. (CLSN), which was hit hard in January of this year, following the failure of phase III trial of its drug candidate ThermoDox in hepatocellular carcinoma, dubbed HEAT, said that the latest overall survival data from its post-hoc analysis of results from the HEAT Study supports continued clinical development.

The company expects to submit its proposed pivotal phase III clinical protocol for FDA review in the fourth quarter of 2013 and anticipates initiating a multicenter global trial in the first half of 2014.

CLSN closed Thursday's trading at $1.20, up 2.56%.

Simeprevir, developed by Johnson & Johnson (JNJ) and its partner Medivir AB for hepatitis C, has been unanimously recommended by the FDA Advisory Committee for combination treatment of genotype 1 chronic hepatitis C in adult patients.

The FDA's final decision on Simeprevir is expected by end of November 2013.

Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 hepatitis C, and is under review in Europe for the treatment of genotype 1 or genotype 4 chronic hepatitis C.

JNJ closed Thursday's trading at $92.35, up 0.27%.

Medical device company Natus Medical Inc. (BABY) touched a new high of $19.98 on Thursday before closing at $19.31, up 27.80 percent from the previous day's close, following record Q3 results.

In the third quarter ended September 30, 2013, the net income was $6.3 million or $0.20 per share on revenue of $85.4 million. This compared with a net loss of $1.7 million or $0.06 per share and revenue of $81.0 million in the year-ago quarter.

The company also increased revenue and earnings guidance for the fourth quarter and full year 2013.

Looking ahead to Q4, 2013, the company now expects revenue of $87 million to $90 million and non-GAAP earnings per share of $0.30 to $0.32. This compares to prior revenue guidance for the fourth quarter 2013 of $84 million to $88 million and non-GAAP earnings per share of $0.22 to $0.25.

For the full year 2013, Natus now anticipates revenue of $340 million to $343 million and non-GAAP earnings per share of $0.95 to $0.97. This compares to prior revenue guidance for the full year 2013 of $332 million to $338 million and non-GAAP earnings per share of $0.76 to $0.82.

Nektar Therapeutics (NKTR) said that a phase II investigator-sponsored study of etirinotecan pegol in patients with relapsed or refractory Small-Cell Lung Cancer has been initiated. The primary endpoint of the study is the 18-week progression-free survival rate.

NKTR closed Thursday's trading at $10.72, up 1.80%.

NPS Pharmaceuticals Inc. (NPSP) has submitted its Biologic License Application for Natpara to the FDA, seeking approval as a treatment of hypoparathyroidism. The BLS submission was based on results of a pivotal phase III study known as REPLACE, a randomized, double-blind, placebo controlled study of 134 patients with hypoparathyroidism.

NPSP was trading around $7 when we alerted readers last August.

The stock closed Thursday's trading 8.31% higher at $30.64.

Portola Pharmaceuticals (PTLA) has begun patient enrollment in its phase 1/2 proof-of-concept clinical study of PRT2070, which is being developed as a treatment for hematologic cancers.

PTLA closed Thursday's trading 1.66% higher at $23.89.

Rigel Pharmaceuticals Inc.'s (RIGL) phase II clinical study of R333 in active skin lesions in patients with discoid lupus erythematosus has failed to meet the primary endpoint. The company has decided not to pursue this indication further with R333.

The company expects to initiate two pivotal phase III studies for Fostamatinib in patients with immune thrombocytopenic purpura in the first half of 2014. Top line data from these studies are expected in 2015.

RIGL closed Thursday's trading at $3.49, down 1.41%.

Zynex Inc. (ZYXI.OB) rose more than 7 percent to $0.25 on Thursday following marketing clearance of its NeuroMove stroke recovery device in China.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

Visit Emerging Biostocks (http://www.rttnews.com/Products/EBSService.aspx) for a complete list of our biotech stock picks.