Ultragenyx Pharmaceuticals Inc (NASDAQ:RARE) said Monday the Food and Drug Administration has granted orphan-drug designation on its triheptanoin, a treatment for glucose transporter type-1 deficiency syndrome (Glut1 DS). Also known as De Vivo disease, Glut1 DS is a rare and potentially severely debilitating disease characterized by seizures, developmental delay, and movement disorder. Ultragenyx Pharma. said it is performing a Phase 2 study of triheptanoin in patients with Glut1 DS. Despite the orphan-drug designation, which would provide seven years of market exclusivity, RARE shares were off 0.8% at $49.81 shortly after Monday's open. Ultragenyx Pharmaceuticals Inc (NASDAQ:RARE) has a 52-week range of $32.02 to $69.77.pSivida Corp. (NASDAQ:PSDV) said it has received a $25 million milestone payment upon U.S. Food and Drug Administration approval of Iluvien, the company's out-licensed treatment of diabetic macular edema. pSivida Corp. (NASDAQ:PSDV) said the payment, together with its cash on hand, should fund planned product development and other operations into 2017. The company will also received 20% of any net profits from sales of ILUVIEN for DME on a country-by-country basis as well as royalties on sales of Retisert.Iluvien is licensed to Alimera Sciences. The drug iis marketed in the U.K. and Germany and has received or is pending marketing authorization in 15 other EU countries for the treatment of chronic DME. In the U.S., ILUVIEN has been approved for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. PSDV closed higher nearly 4% on Friday, in the upper half of the 52-week range between $2.28 and $5.45.Ligand Pharmaceuticals Inc. (NASDAQ:LGND) today reported Q3 results that were in line to below expectations and set mixed guidance. The company reported Q3 adjusted EPS of $0.36, up from $0.20 in Q3 2013 and in line with the analyst estimates of $0.36. Total revenues of $14.97 million were up from $13.00 million in Q3 2013 and shy of the analyst projections of $15.25 million for the quarter. Ligand Pharmaceuticals Inc. (NASDAQ:LGND) reaffirmed its previous full-year 2014 financial forecast and expects total revenues between $64 million and $66 million, and non-GAAP earnings per diluted share between $1.50 and $1.55. The Street is at $64.8 million in revenue and earnings of $1.56 per share. For Q4, Ligand expects total revenues to be between $22.5 million and $24.5 million, and non-GAAP earnings per diluted share to be between $0.57 and $0.62. The Street consensus is $23.3 million in revenue and earnings of $0.65 per share. Shares of LGND are up $0.03, or 0.06%, at $54.00 within a 52-week range of $41.99 - $80.42.
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