September 2, 2016
By Mark Terry, BioSpace.com Breaking News Staff
September is going to be a busy month as seven biotech companies face big decisions by the U.S. Food and Drug Administration. Chris Lange, writing for 24/7 Wall Street, takes a look.
Based in New Haven, Connecticut, Achillion Pharmaceuticals is focusing on hepatitis C drugs using complement factor D inhibitors. On September 23, it is presenting data from a Phase IIa trial that’s focused on safety, pharmacokinetics and efficacy of doublet and triplet regiments for genotype 1 hepatitis C virus (HCV). The trial is a joint deal with Alios BioPharma, a part of Johnson & Johnson .
Achillion is currently trading for $8.22.
Dublin-based Amarin Corporation works to develop drugs for cardiovascular diseases. The company recently announced the completion of a study of 8,175 patients to evaluate if Vascepa cuts cardiovascular events in patients who are on statins, but still have elevated triglyceride levels and other cardiovascular risk factors. Enrollment closed in June.
Although final data won’t happen until the second half of 2017 or later, interim analysis is expected this month.
Amarin is currently trading at $2.84.
Array BioPharma is headquartered in Boulder, Colorado. The company focuses on cancer treatments. The company announced yesterday that the FDA had accepted its New Drug Application (NDA) for binimetinib for NRAS-mutant melanoma. The PDUFA date is June 30, 2017.
Array is currently trading for $3.48.
Mast Therapeutics , based in San Diego, focuses on developing drugs for sickle cell disease and heart failure using its MAST (Molecular Adhesion and Sealant Technology) platform. The company is expected to announce topline data this month from its EPIC clinical trial of 388 patients with sickle cell disease. It is still enrolling patients for vepoloxamer’s EPIC-E trial.
Mast Therapeutics is currently trading for $0.51.
Novavax , headquartered in Rockville, Maryland, uses recombinant nanoparticles and its Matrix-M adjuvant technology to develop vaccines. The company is expecting to report on its Phase III trial for respiratory syncytial virus (RSV) this month. Todd Campbell, writing for The Motley Fool, said, “If RSV-F is eventually approved, then Novavax believes its addressable market in the United States could exceed 100 million people in 2020. That has management thinking that peak annual sales for RSV-F could be north of $6 billion.”
Novavax is currently trading for $6.845.
South San Francisco-based 6. Threshold Pharmaceuticals is an oncology company. It currently is developing two drugs based on hypoxia-activated prodrug technology, evofosfamide and tarloxtinib bromide. The company plans to report this month on its Phase II proof of concept trial of tarloxotinib in hypoxic tumors. The company recently reported Phase III trial of evofosfamide, and continued collaborations on the drug in pancreatic neuroendocrine tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC).
Threshold is currently trading for $1.18.
Vertex Pharmaceutical is based in Boston, and focuses on cystic fibrosis (CF) drugs. Its drug, Kalydeco had $632 million in sales in 2015, and its Orkambi gained approval in the U.S. and Europe. The company is planning to report this month on a Phase II trial of Orkambi in children with CF. The FDA approved Vertex’s request for a PDUFA Priority Review by the end of this month.
Vertex is currently trading for $94.41.
