Biotech was the biggest laggard industry among all sectors. Courtesy to shares of Sarepta Therapeutics Inc(NASDAQ:SRPT) which surrendered almost 50% in premarket session Tuesday following the firm revealed some passive news from the Food and Drug Administration. In a note, the firm reported an FDA advisory committee did not suggest the acceptance of its drug eteplirsen, made for a disease named as Duchenne muscular dystrophy.
The advisory committee gave 3 – 7, with three abstentions, against finding substantial evidence based on the clinical earnings of the single historically controlled study (Study 201/202) that eteplirsen is operative for cure of DMD (FDA Question #7),” the firm added. Shares of Sarepta Therapeutics opened lower almost 50%. In early trading, shares were lower 78% year-to-date. Piper Jaffray’s Edward Tenthoff was more bearish still, as he downgraded Sarepta Therapeutics to Underweight, and dropped his price target from $15 to $6. He thinks there’s “slight chance” for eteplirsen approval by the May 26 FDA action date.
Among the major gainers OncoGenex Pharmaceuticals Inc(NASDAQ:OGXI) and InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) shares were rallying 22% and 13% on unusual surging volume.
InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) recently declared that the sixth-implanted patient in the INSPIRE study has enhanced from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This is the fourth out of the initial six patients (67%) with almost two months of follow up data to have had an AIS grade enhancement. The Objective Performance Criterion (OPC), an amount of study achievement for the INSPIRE study, is defined as 25% or more of the patients having enhanced by almost one AIS grade by six months post-implantation. Many huge natural history databases show that lesser than 16% of patients with overall thoracic injuries have an AIS grade enhancement by six months post-injury.