October 2, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Investors get ready. Three small-cap biotechs are facing catalysts that could yield big rewards, according to one analyst.
Shares of Burlington, Mass.-based Flexion Therapeutics are up more than 8 percent this morning, trading at $26.30 as of 10:59 a.m. Since June, stock prices for Flexion have increased steadily, according to an analysis from Real Money, a publication from The Street. Investors are anxiously waiting the U.S. Food and Drug Administration’s ruling on Zilretta, a treatment for osteoarthritis in the knee. The FDA is set to make a decision on Oct. 6. Phase III data shows that Zilretta was able to demonstrate a “highly significant” reduction in average daily pain versus placebo in patients with moderate to severe OA-associated knee pain. Zilretta also reduced the amount of analgesic rescue medications during recovery, the company said earlier this month. Analysts have projected, if Zilretta is approved, that it could hit $500 to $600 million in peak sales. If it is approved for other joint indications, it could hit the $1 billion blockbuster target.
Bay Area’s Dynavax began 2017 with a restructuring that caused a 38 percent reduction in staff. That followed the FDA’s November 2016 rejection of Heplisav-B, an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. Dynavax started the year with share prices at $4.05. Since then though stock prices have steadily climbed to $23.10 as of this morning. Since the 2016 rejection of Heplisav-B, Dynavax has been furiously working to fix the issues in order for regulatory approval. The company is anticipating a new FDA decision in November. This morning Reuters reported that Dynavax has been looking at its options with Heplisav-B and could be aiming to sell the nearly-approved treatment. One factor that could support that notion of a potential sale or marketing deal is the fact Dynavax has shifted much of its focus to the company’s immuno-oncology portfolio. Real Money pointed to expected mid-stage trial data for SD-101, a Dynavax immuno-oncology program, as another potential catalyst for investors.
Shares of Progenics Pharmaceuticals have lost much of its value since March, when shares traded at $11.60. This morning prices are up more than 4 percent to $7.67 as of 11:13 a.m. Progenics is anticipating the FDA ruling on its lead cancer drug candidate next year. Azedra, a radiotherapeutic product, is being developed for recurrent pheochromocytoma and paraganglioma, which are tumors found in the adrenal glands and outside of the adrenal glands. In September, the company announced Azedra demonstrated clinically meaningful and durable responses across endpoints in a Phase IIb trial. Patients achieved a sustained reduction of antihypertensive medications which was correlated with favorable tumor responses, the company said.
