Discovery Laboratories (NASDAQ:DSCO), often compared to the likes of Cell Therapeutics (NASDAQ:CTIC), Arena (NASDAQ:ARNA), Dendreon (NASDAQ:DNDN), and OREX (NASDAQ:OREX) saw its shares rise more than 8.52% on Tuesday’s trading, making it one of the highest gainers on any major exchange for the day. The excitement comes following growing anticipation that they will file a request for hearing to maintain its listing on the NASDAQ exchange sooner rather than later, as well as move one step closer to its NDA resubmission of its flagship product, Surfaxin, during 1st quarter of 2011. It is important to note that the FDA granted Discovery Labs Orphan Drug designation for Surfaxin for the treatment of RDS in premature infants, and the EMEA granted Discovery Labs Orphan Drug designation for Surfaxin for the prevention and treatment of RDS in premature infants. An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
Several sources have also indicated that a short squeeze could be taking place ahead of the pending catalyst. The company has more than 7.35 million shares short out of a total 158 million float, and of these the shorts have roughly seven days to cover.
FDA Timeline
Surfaxin, a synthetic peptide-containing lung surfactant, completed re-validation of Biological Activity Test (BAT) for quality control and stability in May 2010. Then, it was submitted via protocol to FDA which was a completed required preclinical program with written guidance from FDA that was received in June 2010. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
Dr. Russell Clayton, Vice President, Research and Development, Preclinical and Regulatory Affairs commented, “Discovery’s plan for the potential approval of Surfaxin continues to benefit from the FDA’s direction and their recent suggestions have been incorporated into our plan. Another positive aspect of the most recent communication is the FDA’s indicated willingness to continue to interact on our approach to gain potential Surfaxin approval.”
Positive Clinical Trials
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