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CHTP Gets FDA Nod, NPSP Reverses Loss, DVAX Withdraws HEPLISAV EU Application

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ANI Pharmaceuticals Inc. (ANIP) rose more than 11 percent to close Tuesday's trading at $23.96 following stellar Q4 results. Fourth quarter net revenues were $10.5 million, an increase of 98% over the year-ago quarter, thanks to a 170% increase in net prescription sales driven by increased sales of and price increases for the company's Esterified Estrogen with Methyltestosterone Tablet product.

Net income from continuing operations for Q4, 2013 was $3.4 million or $0.35 per share compared to a net loss of $1.2 million in the prior year period.

Cellceutix Corp. (CTIX.OB), which is aiming to move its psoriasis drug candidate Prurisol into clinic, has submitted an Investigational New Drug Application to the FDA.

Per regulatory protocol, the FDA has 30 days to review the IND. If the FDA in that time frame raises no questions, the first clinical trial of Prurisol is allowed to begin.

CTIX.OB closed Tuesday's trading 4.42% higher at $1.89.

Chelsea Therapeutics International Ltd.'s (CHTP) NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension has been granted accelerated approval by FDA.

Symptomatic neurogenic orthostatic hypotension is an autonomic nervous system disorder caused by failure to produce and or release adequate amounts of norepinephrine upon standing. Norepinephrine deficiency results in an inability for a person to maintain adequate blood pressure and blood flow to the brain when upright, frequently resulting in dizziness, lightheadedness, blurred vision, fatigue, poor concentration and fainting episodes.

NORTHERA becomes the first and only therapy approved by FDA which demonstrates symptomatic benefit in patients with neurogenic orthostatic hypotension.

CHTP closed Tuesday's trading 4.65% higher at $4.95. In extended trading, the stock soared over 35% to $6.71.

CytoDyn Inc. (CYDY.OB) has submitted a phase 2b clinical trial protocol for its lead product candidate, PRO 140, to the FDA for treatment substitution in patients with Human Immunodeficiency Virus.

The purpose of the study is to evaluate the efficacy of PRO 140 monotherapy for the maintenance of viral suppression in HIV patients who are stable on combination antiretroviral therapy, known as HAART (highly active antiretroviral therapy), but need or wish to discontinue HAART therapy temporarily.

CYDY.OB rose 15.78% to close Tuesday's trading at $0.99.

Dynavax Technologies Corp. (DVAX) has withdrawn the Marketing Authorization Application for HEPLISAV, its investigational hepatitis B vaccine, as the European regulatory agency considers the current HEPLISAV safety database to be too small to rule out a risk of less common serious adverse events.

The company expects to begin shortly an additional HEPLISAV clinical trial, HBV-23, that is intended to provide a safety database sufficient to support licensure.

The FDA refused to approve HEPLISAV last February due to insufficient data to adequately support its safety, and the company has planned to conduct an additional study to provide a sufficiently-sized safety database.

DVAX closed Tuesday's trading 2.27% higher at $1.80.

NPS Pharmaceuticals Inc. (NPSP) gained 2.77% to touch $39 in extended trading on Tuesday as the company reversed its net loss and doubled its total revenue in Q4, 2013 from the year-ago quarter.

The company's hypoparathyroidism product candidate Natpara is under FDA review with a decision date slated for October 24, 2014. A Marketing Authorization Application for Natpara in Hypoparathyroidism is expected to be submitted to the EMA this year.

Navidea Biopharmaceuticals Inc.'s (NAVB) supplemental New Drug Application for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer has been accepted by FDA and granted priority review. Accordingly, the FDA's decision is slated for June 16, 2014.

NAVB closed Tuesday's trading at $1.94, up 3.74%. In after-hours, the stock rose 2.06% to $1.98.

OncoMed Pharmaceuticals Inc. (OMED) has started a multi-center phase 1b clinical trial of OMP-54F28 with Nexavar in hepatocellular cancer. This is the second of three phase 1b trials for OMP-54F28 to begin patient enrollment. A phase 1b of OMP-54F28 with Abraxane and Gemcitabine in pancreatic cancer was initiated earlier this year.

OMED closed Wednesday's trading at $36.13, up 3.88%.

Prana Biotechnology's (PRAN) phase II trial, dubbed REACH2HD, investigating PBT2 as a treatment for Huntington disease has met the safety and efficacy endpoints. The company plans to advance PBT2 into a confirmatory phase III clinical trial that could allow PBT2 to be approved for the treatment of Huntington disease.

PRAN rose 39.31% to close Tuesday's trading at $10.10.

by RTT Staff Writer

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