November 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In the biotech world, there are a number of potential catalysts that can send a stock soaring to the skies or plunging to the earth. They can be PDUFA dates, clinical trial results, decisions by the U.S. Food and Drug Administration (FDA), or a variety of business or scientific news along the way. Here are five biotech companies facing potential potential catalysts between now and Christmas.
1. Genentech
On September 13, Genentech , a member of the Roche group, released new analysis of three Phase III trials of Ocrevus (ocrelizumab) in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said Xavier Montalban, professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, in Barcelona, Spain, in a statement. “Ocrevus significantly impacted three key disability measures, which further highlights its clinical significance in people with primary progressive MS.”
The drug has a PDUFA date in the U.S. of December 28. Projected sales of the drug, if approved, are $4 billion by 2022.
Roche is currently trading for 227.10 CHF.
2. Advanced Accelerator Application SA
Based in Saint-Genis-Pouilly, France, the company’s Lutathera is under development for the treatment of neuroendocrine tumors (NETs). In September, the company indicated that the European Medicines Agency (EMA)’s review of its Marketing Authorization Application (MAA), which had an Accelerated Assessment, had been modified to a standard review period because the EMA requested additional clarifications, as well as an inspection of one of the company’s contract research organizations (CRO).
However, the U.S. FDA had accepted the company’s New Drug Application (NDA), and has a PDUFA date of December 28.
Advanced Accelerator Application SA stock is currently trading for $33.91 (US).
Acadia Pharmaceuticals recently launched its only product, Nuplazid (pimavansrin) to treat Parkinson’s psychosis. In the first quarter of sales, the drug brought in $5.2 million, double that of Wall Street projections.
The company is expecting to announce top-line results from a Phase II study of the drug for Alzheimer’s disease psychosis before the end of the year, which if positive, would significantly expand the drug’s market.
ACADIA is currently trading for $28.04.
The company has a cannabis-related peppermint-flavored mouth spray called Sativex used to treat spasticity related to MS. It is marketed in 16 countries outside the U.S., has received regulatory approval in 12 more, and is being evaluated in the U.S. in a Phase II trial in spasticity due to cerebral palsy. Data from the trials are expected before the end of the year.
is currently trading for $117.47.
Horizon Pharma ’s Actimmune (interferon gamma-1b) is approved by the FDA to treat chronic granulomatous disease (CGD) and severe, malignant osteopetrosis (SML). The company is expected to release top-line data from a Phase III trial of the drug in December for Friedreich’s ataxia. That indication alone has a possible $500 million to $1 billion peak annual net sales potential.
Horizon is currently trading for $21.49.
