As the opening bell rang to start another week of trading, Lpath (OTC: LPTN) announced the FDA had lifted the hold on the company’s iSONEP. The monoclonal anti-body is being developed as a treatment for Wet Age Related Macular Degeneration (AMD) and other possible ocular disorders, which can cause a loss of vision. Wet AMD affects about 10% of all people with AMD.
The FDA placed a hold on iSONEP at the beginning of the year after it found Lpath’s fill/finish contractor non-compliant with the government agency’s Good Manufacturing Practice during the time when the clinical vials were filled in 2008-2010. The company has manufactured new vial material using a different fill/finish contractor. The contractor and new drug batch met all government requirements, and thus, the hold was lifted. Lpath will immediately resume enrollment for the Nexus Phase 2 study with a target date in mid-September for treating its first patient.
The news put a giddy-up in the feet of buyers as the stock traded 15 cents higher in the first 30 minutes than last Friday’s closing print of $0.80. The early session print at $0.95 also marked the high for the day. Shares spent the remainder of the day trading a few pennies above and below $0.85. When the day’s closing bell rang, the stock finished the day with a gain of 5% to close up five cents at $0.85. Shares traded as low as$0.82 during the session. Volume exceeded 300,000 compared to the daily average of 186,000.
The FDA hold in January came just a day after the stock had hit a 52-week high of $1.40. Traders reacted to the suspension by pulling share prices down more than 40%. Buyers showed little interest in the stock during the spring and prices drifted lower, eventually hitting a new annual low in mid-June when shares traded for $0.65.
Lpath shares began to bounce in July when Aegis initiated coverage of the stock with a “buy” rating and a $6.00 price target. Share prices recovered to almost $1.00 at the beginning of August and then slid back toward $0.70. With the road cleared for the next phase, traders must decide if buyers will return to the stock with the same enthusiasm they showed before the FDA hold.
Newsletters and stock promotions have been rather quiet on the stock over the last year. A check of Stockreads.com and Stockpromoters.com showed no recent activity touting shares of Lpath. Twitter saw some chatter today. @PennyStockHaven chimed in about the FDA news, and @TurboResearch seemed less than impressed by the stock action.
The San Diego company focuses on the development of lipidomic-based therapeutic antibodies to treat human diseases. Lpath products are currently in clinical development and pre-clinical evaluation. The company was founded in 1997.
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