By RTT News, October 02, 2013, 09:28:00 AM EDT
(RTTNews.com) - Shares of pSivida Corp. ( PSDV ) have gained a whopping 126% in the past six months, and trade around $5.40.
For readers who are new to pSivida, here's a brief description about the company and the upcoming event to watch out for...
pSivida is a specialty pharmaceutical company focused on developing sustained release drugs for treatment of back-of-the-eye diseases. Iluvien, an intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for diabetic macular edema, developed by pSivida, is licensed to Alimera Sciences Inc. ( ALIM ).
After having been twice rejected by FDA, in December 2010 and in November 2011, the NDA for Iluvien, seeking approval in the indication of chronic diabetic macular edema, was resubmitted by Alimera in April of this year. The following month, on May 1st, the resubmitted NDA for ILUVIEN was accepted for review by the FDA, with a decision date set for October 17, 2013.
Iluvien is approved for marketing in the U.K., Austria, France, Germany, Portugal and Spain.
pSivida's licensee Alimera has commercially launched Iluvien in the U.K. and Germany. pSivida is entitled to 20% of net profits from sales of Iluvien by Alimera in Germany as well as the U.K.
On June 14, 2013, reversing its earlier stance, the drug price watchdog in the U.K. - National Institute for Health and Care Excellence (NICE) - issued draft guidance recommending Iluvien for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema considered insufficiently responsive to available therapies.
The final guidance recommending Iluvien was issued by NICE on Sep.30, 2013, and the NHS reimbursement is expected to follow in England and Wales under the patient access scheme submitted by Alimera.
The next catalyst to watch out for is the FDA decision on Iluvien. If approved, pSivida is entitled to an additional $25 million milestone payment from Alimera as well as 20 percent of net profits on any sales in the U.S. by Alimera.
PSDV was trading around $2.30 when we alerted readers on March 27, 2013. Had you bought the stock around that time, you would have gained 133 percent based on yesterday's closing price of $5.38.
Again, it's all about the timing. Buying the right stocks at right prices will maximize returns while minimizing risk.
PSDV is just one among our more than 20 stock picks in 2013 that have fetched triple-digit gains to investors. Want to know more about them?
Visit our premium Emerging Biostocks newsletter (http://www.rttnews.com/Products/EBSService.aspx) for a complete list of our stock picks.
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