Shares of Chelsea Therapeutics International Ltd. (CHTP) were up more than 146 percent in after-hours trading on Tuesday following FDA panel's positive vote on the company's New Drug Application for Northera.
The company is seeking approval of Northera for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The FDA panel has voted 16-1 to recommend approval of Northera, and the final decision of the FDA is slated for February 14, 2014.
In a move that will expand its portfolio of advanced wound care products into the growing skin substitute market, Derma Sciences Inc. (DSCI) has licensed exclusive rights to two novel human placental-derived tissue products for all dermal indications in the advanced wound care and burn markets from privately-held BioD LLC.
Terms of the license include an upfront cash payment, royalties on product sales and performance-based milestones to be paid in cash and Derma Sciences stock options.
DSCI closed Tuesday's trading 2.54% higher at $12.11.
MEI Pharma Inc. (MEIP) has initiated a phase II clinical trial of its experimental drug Pracinostat in patients with refractory myelodysplastic syndrome. The company expects to report preliminary data from this trial later this year.
Two other phase II trials of Pracinostat are also underway - one, a placebo-controlled phase II trial of Pracinostat in combination with Vidaza in patients with previously untreated intermediate-2 or high-risk MDS, and the other - a two-stage phase II trial of Pracinostat in combination with Vidaza in elderly patients with newly diagnosed acute myeloid leukemia.
Data from the two trials are also anticipated by December 2014.
MEIP closed Tuesday's trading at $8.30, up 1.10%.
Shares of MediciNova, Inc. (MNOV) rose as much as $5.25 in intraday trading on Tuesday before closing at $2.84 following positive results of its drug candidate MN-001 for the treatment of NASH (nonalcoholic steatohepatitis) in a mouse model. The company is preparing to initiate a phase II trial of MN-001 for the treatment of NASH in the U.S.
OncoSec Medical Inc. (ONCS.OB) expects to complete enrollment in a phase II study of OMS-I110 in merkel cell carcinoma in the first quarter and report additional data from the trial in mid 2014.
ONCS.OB touched a 52-week high of $0.57 on Tuesday before closing at $0.51, down 5.56%.
Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has dosed the first subject in a phase I human clinical trial of TKM-Ebola, an anti-Ebola viral therapeutic that is being developed under a US$140 million contract with the U.S. Department of Defense.
The company expects to have data from this trial in the second half of this year.
TKMR closed Tuesday's trading at $11.35, down 5.73%.
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