December 30, 2016
By Mark Terry, BioSpace.com Breaking News Staff
With 2016 on its way out and 2017 right around the corner, Chris Lange, writing for 24/7 Wall Street, looks at seven upcoming potential catalysts expected in the biopharma industry in the first two months of the new year.
Based in New York City, Synergy Pharmaceuticals is awaiting the U.S. Food and Drug Administration (FDA)’s decision on its New Drug Application (NDA) for plecanatide to treat chronic idiopathic constipation. The drug’s PDUFA data is January 29, 2017.
Synergy is currently trading for $6.10. A consensus analyst price target is $10.80.
Headquartered in Karmiel, Israel, Protalix BioTherapeutics recently completed patient enrollment in its Phase II trial of AIR DNase (PRX-110) to treat cystic fibrosis (CF). The company expects to report interim data in the first week of January 2017, with full results in the first quarter.
Protalix is currently trading for $0.45.
3. Tesaro
Based in Waltham, Mass., Tesaro has a PDUFA date of January 11, 2017 for its intravenous (IV) formulation of rolapitant to treat chemotherapy-induced nausea and vomiting. There is also a great deal of interest in the company’s niraparib for ovarian cancer, which has made it the target of acquisition rumors.
Tesaro is currently trading for $134.34.
Based in Bedford, Mass., Ocular Therapeutix focuses on sustained ophthalmic therapies. On November 14, it announced positive topline results from its Phase III trial of Dextenza to treat post-surgical ocular inflammation and pain. It is expected to submit its NDA in the first quarter of 2017, after it completes testing of its commercial batches.
Ocular Therapeutix is currently trading for $8.34.
Located in San Diego, Neurocrine Biosciences focuses on neurological and endocrine diseases. The company is expected to report topline data from its Phase II trial of Ingrezza to treat moderate to severe Tourette’s. During the year, it also plans to release data from other trials of the drug for related, but similar indications. For example, the PDUFA data is April 11, 2017, for the drug to treat tardive dyskinesia.
Neurocrine Biosciences is currently trading for $37.97.
Lexicon Pharmaceuticals is headquartered in The Woodlands, Texas. On December 21, it reported that its sotagliflozin met its primary endpoint for type 1 diabetes in a Phase III trial.
In September, the FDA required more time to finish its review of the company’s NDA for telotristat eiprate to treat carcinoid syndrome. The PDUFA date for the drug is now February 28, 2017.
Lexicon is currently trading for $13.89.
7. FibroGen
Headquartered in San Francisco, FibroGen is focused on connective tissue growth factor (CTGF) and hypoxia-inducible factor (HIF) biology. 2017 has the potential to be a big year for the company. It is expected to announce topline data from its Phase III trial for Roxadustat (FG-4592) to treat anemia in chronic kidney disease in early 2017. It also plans to release interim data from a Phase II trial of Pamrevlumab (FG-3019) to treat pancreatic cancer in January 2017.
FibroGen is currently trading for $21.95.
