<P>After Coronado Biosciences Inc. reported two trial failures this year in Crohn’s disease with its oral Trichuris suis ova (TSO, or pig whipworm eggs), investors’ faith had fallen low in the unusual immune system-based approach, but Wall Street sang a different song when the company unveiled positive data from a pilot study in the seemingly unlikely indication of autism. <!--break--></P>
The prevalence of sickle cell disease (SCD) is a challenge for the healthcare systems around the world. There are very limited treatment options and, as yet, no effective therapies that address the underlying cause of the disease.
After Coronado Biosciences Inc. reported two trial failures this year in Crohn’s disease with its oral Trichuris suis ova (TSO, or pig whipworm eggs), investors’ faith had fallen low in the unusual immune system-based approach, but Wall Street sang a different song when the company unveiled positive data from a pilot study in the seemingly unlikely indication of autism.
Oversized hopes for what the company designed as an exploratory Phase II trial led to Immunocellular Therapeutics Ltd.’s stock plunge, after the company disclosed mixed results with its dendritic cell-based vaccine in glioblastoma multiforme (GBM), said CEO Andrew Gengos.
Hopes raised just over a month ago by encouraging interim Phase IIb data with aldoxorubicin (aldox) in soft-tissue sarcomas (STS) were met and then some by Cytrx Corp., which disclosed top-line results that show an 80 percent to 100 percent improvement in progression-free survival (PFS) with the compound.
Shooting for an accelerated approval with priority review, Spectrum Pharmaceuticals Inc. submitted the new drug application (NDA) for belinostat, a pan-histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL), and it expects a response from the FDA within 60 days.
Gilead Sciences Inc.’s Sovaldi (sofosbuvir) fared better than some expected in the FDA approval made public late in the day Friday, when the agency gave its blessing to 400-mg tablets of the once-daily nucleotide analog polymerase inhibitor for chronic hepatitis C virus (HCV) as part of a combination antiviral treatment regimen.
As expected, the FDA approved Gilead Sciences Inc.’s Sovaldi (sofosbuvir) 400-mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for chronic hepatitis C virus, as part of a combination antiviral treatment regimen.
Positive Phase III data with Breo Ellipta in asthma reported by Theravance Inc. and partner Glaxosmithkline plc (GSK) could let them join two major competitors in the field, but with a once-a-day rather than twice-a-day, therapy, which is already approved for chronic obstructive pulmonary disorder (COPD).
Celldex Therapeutics Inc.’s public offering of 7 million shares at $24.50 each brings net proceeds of about $162.7 million, which should get the Hampton, N.J.-based firm “comfortably through 2016,” said CEO Anthony Marucci. “We came into the [financing] with $136.6 million already on the balance sheet,” he noted.
