October 4, 2016
By Mark Terry, BioSpace.com Breaking News Staff
As the year enters its final quarter, a number of biotech companies are expected to release trial updates or face regulatory decisions. Here’s a look at 10 biotech companies investors should keep an eye on.
Hampton, New Jersey-based Celldex Therapeutics is scheduled to present an update on its melanoma drug glembatumumab vedotin on October 8 at the European Society for Medical Oncology Congress. Glembatumumab is also in a Phase IIb trial for triple-negative breast cancer, and an open-label Phase I/II safety and tolerability trial in patients with unresectable stage IIIB or IV, gpNMB-expressing, advanced or metastatic squamous cell carcinoma (SCC) of the lung. If the drug is approved for triple-negative breast cancer alone, it could hit $1 billion in annual sales. So the potential is high.
Celldex is currently trading for $4.27.
Acadia Pharmaceuticals , based in San Diego, is planning on updating its Phase II clinical trial on Nuplazid (pimavanserin) in Alzheimer’s disease. It recently was approved for hallucinations and delusions associated with Parkinson’s disease. Investors will also be watching to see how Nuplazid sales are going.
Acadia is currently trading for $30.50.
Theravance , headquartered in South San Francisco, is expected to provide an update on its Phase III trial of Revefanacin in chronic obstructive pulmonary disease (COPD) sometime this quarter. If the drug is approved, it would be the first long-acting nebulized muscarinic antagonist (LAMA) for COPD. That market is estimated at $11 billion annually.
Theravance is currently trading for $36.51.
Parsippany, New Jersey-based The Medicines Company will be provided an update on two programs on November 15. The first is a Phase II interim update on PCSKsi for atherosclerotic cardiovascular disease (ASCVD). The other is a Phase II update on MDCO-216 for acute coronary syndrome (ACS). Both will be presented at the American Heart Association’s Scientific Sessions conference.
The Medicines Company is presently trading for $38.12.
Dynavax Technologies Corporation based in Berkeley, California, is waiting for a decision by the U.S. Food and Drug Administration (FDA) on or before December 15 on Heplisav-B to treat hepatitis B in people with type 2 diabetes. The FDA’s Center for Biologics Evaluation and Research cancelled a meeting scheduled for November 16 to review the Biologics License Application (BLA), because it had some questions it wanted to review first. The PDUFA date of December 15 remained.
Although the drug had some issues in 2013 when it was linked to some autoimmune disorders, in preliminary Phase III data, Heplisav-B provided seroprotection in 90 percent of participants compared to a 65 percent response for standard HBV treatment Engerix-B.
Dynavax is currently trading for $11.92.
Chapel Hill, North Carolina-based Cempra Pharmaceuticals is facing two FDA PDUFA dates this quarter. The first is December 27, for an oral version of Solithera to treat community-acquired bacterial pneumonia (CABP). The second is the next day, December 28, when the FDA decides on an injectable form of Solithera to treat CABP.
Cempra is currently trading for $22.78.
7. Advanced Accelerator Application
France’s Advanced Accelerator Application has a PDUFA from the FDA on December 28 for Lutathera, which has priority review status. Lutathera is a Lu-177-labeled somatostatin analogue peptide to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). NETs are a group of tumors that originate in the neuroendocrine cells of several different organs. They are rare, but are the second most common type of gastrointestinal malignancy.
Advanced Accelerator Application is currently trading for $37.79.
Los Angeles-based Puma Biotechnology is expecting an update sometime this quarter on its Phase II trial of Neratinib as a standalone treatment for hormone receptor-positive breast cancer. It is also being evaluated as a combo treatment for HER2 breast cancer. Some investors believe Puma is a hot target for acquisition for companies interested in bolstering their oncology presence.
Puma is currently trading for $62.91.
Pfizer acquired Medivation (MDVN) in August for $14 billion. Its hot prostate cancer drug Xtandi is already on the market, but Pfizer stockholders will want to pay attention, because the drug has a PDUFA date of Oct. 22 in metastatic castrate-resistant prostate cancer, which would expand its market. Pfizer is currently trading for $33.65.
GW Pharmaceuticals plc bases its therapeutics on cannabis. Its Sativex is approved to treat multiple sclerosis-related spasticity in 15 countries outside the U.S. Sometime this quarter it is expected to update on GWP-42002 and GWP-42003 as treatments for glioma. Its Epidiolex is a liquid formulation of plant-derived Cannabidiol, and has been granted Orphan Drug Designation by the FDA to treat Dravet syndrome and Lennox-Gastaut syndrome, and has Fast Track Designation for Dravet syndrome. It could be approved as early as 2017, and analysts with Cowen & Co. project annual sales could exceed $800 million.
There have been rumors that GW is an acquisition target, although the company has indicated it’s not currently interested in a sale. Potential buyers focused on central nervous system disorders include Allergan and Biogen .
GW Pharmaceutical is currently trading for $131.30.
