August 3, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – If you’re looking to beef up your pharma and biotech stock portfolio, analysts at the Motley Fool have selected seven stocks that could make big moves this year due to anticipated “regulatory of clinical catalysts” expected within the next year.
Last year, Agenus saw a drop, but then made a gamble after the company mortgaged revenue from some of its vaccines in exchange for $115 million in funding to advance its immuno-oncology programs. That gamble appears to be paying off as it has several checkpoint inhibitors enter the clinic in 2017. Fool analysts said the company’s checkpoint inhibitors, including AGEN2041 and AGEN1884, each have the potential to capture hundreds of millions in sales if they pass regulatory hurdles. Shares of Agenus are trading at $5.70 this morning. The stock has steadily climbed since early May, when it was trading at a low of $3.01 per share.
Booming RNAi therapeutics company Alnylam Pharmaceuticals is expected to release top line results from its Phase III lead candidate Patisiran for familial amyloidotic polyneuropathy form of transthyretin-mediated amyloidosis at a small lab in Cambridge. The Boston-based company anticipates Patisiran to clear Phase III development by next year, with an NDA filing in late 2017. By the end of 2020, Alnylam expects to achieve a profile of three marketed products and 10 RNAi therapeutic clinical programs. Shares of Alnylam are currently down this morning, trading at $70.38.
Clovis Oncology has had a rough year, particularly with the failure to gain regulatory approval for its experimental drug rociletinib. However, the company that was forced to lay off about 35 percent of its workforce earlier this year is hoping for positive Phase III results for rucaparib, a PARP inhibitor developed for the treatment of patients with platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. If the results are good, Clovis hopes to overcome its disappointing first half of 2016 and begin 2917 with a New Drug Approval application to the U.S. Food and Drug Administration.
Cancer treatment company Exelixis is expecting data from its Phase III live cancer drug, cabozantinib, later this year. Cabozantinib, a kinase inhibitor, is designed for a late-line of therapy, but if approved, could prove to be a strong revenue generator, Fool analysts said. Shares of Exelixis are trading at $9.27 this morning.
Kite Pharma is gearing up for results from its lead CAR T-cell product candidate, KTE-C19. KTE-C19 is currently in a mid-stage study for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL). If results from the trial are good, the company could look at 2017 as the year to file its NDA with the FDA. Analysts are predicting sales of $1.7 billion for KTE-C19 if the drug is approved. KTE-C19 is designed to genetically modify a patient’s T cells to express a Chimeric Antigen Receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Shares of Kite are up this morning, trading at $57.76.
Novavax is expected to provide an update on its RSV (respiratory syncytial virus) F vaccine during the third quarter. The drug has been fast-tracked by the FDA. If the treatment passes regulatory hurdles, the company anticipates the drug could become a blockbuster and generate up to $8 billion in annual revenue. Shares of Novavax are currently trading at $7.40.
Shares of Trevena Inc. are trading at $6.61 this morning. The company is anticipating data from two Phase III trials for its pain treatment, oliceridine, in 2017. Fool analysts say the drug could be a viable option to morphine, which would certainly mean revenue for the company.
