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Some might call investing in small-cap biotech stocks a different kind of madness. While it's true that many of these biotech stocks are very risky, some have upcoming catalysts that could make them good picks for more adventurous investors.
Here's why buying Coherus BioSciences (NASDAQ: CHRS), Halozyme Therapeutics (NASDAQ: HALO), PTC Therapeutics (NASDAQ: PTCT), Radius Health (NASDAQ: RDUS), and Spark Therapeutics (NASDAQ: ONCE) this month could be a form of March Madness that pays off big.
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Coherus BioSciences: Boosts from biosimilars
Shares of Coherus BioSciences are up around 70% over the last 12 months. More gains could be on the way. Coherus should receive a decision from the U.S. Food and Drug Administration (FDA) on approval of its biosimilar to Neulasta by early June. The biotech anticipates European approval in the fourth quarter of 2017.
Coherus also expects to file for U.S. and European regulatory approval for its biosimilar to Humira and for European approval for a biosimilar to Enbrel this year. However, the small biotech is involved in legal litigation with AbbVie that could delay the Humira biosimilar from reaching the market anytime soon.
Still, though, regulatory approval for the Neulasta biosimilar should provide a big boost to Coherus BioSciences stock. Neulasta is the top-selling cancer drug in the U.S. The market could be ripe for Coherus to score big with its biosimilar candidate.
Halozyme Therapeutics: Riding Rituxan's coattails
Halozyme Therapeutics' share price is up close to 60% over the last 12 months. The company's success has been driven by itsproprietary recombinant human hyaluronidase enzyme (rHuPH20). This enzyme enables betterdispersion and absorption of chemotherapies and immunotherapies that are injected under the skin.
Roche expects a decision from the FDA in June for a subcutaneous (under the skin) formulation of Rituxan in treatingchronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). Approval would be great for Halozyme also, since the Rituxan formulation uses rHuPH20. Halozyme stands to receive mid-single-digit percentage royalties on all sales.
PTC Therapeutics: More opportunities for Translarna
PTC Therapeutics' stock has also done quite well, soaring 70% over the last year. The small biotech has one approved product in Europe -- Translarna. PTC hopes to enjoy more success with the drug in 2017.
The FDA refused to accept PTC Therapeutics' filing for Translarna in treating Duchenne muscular dystrophy (DMD) last year. However, PTC plans to submit its regulatory filing for the drug under protest by the end of the month.The biotech also expects results from a late-stage study of Translarna in treating cystic fibrosis in March.
Although it could be a while before anything happens with the DMD filing for Translarna, positive results from the cystic fibrosis study should be another catalyst for PTC.
Radius Health: Ready to run
Radius Health's share price is up more than 40% over the last year even after losing momentum in recent months. The hopes to soon receive good news in the U.S. and Europe for its lead product, abaloparatide-SC.
An FDA decision for the drug in treatingpostmenopausal women with osteoporosis should be made by the end of March.Radius also expects to receive an opinion from the European Medicines Agency'sCommittee for Medicinal Products for Human Use (CHMP) this year.
If the FDA gives a green light for abaloparatide-SC, look for Radius Health stock to regain much of its lost momentum. The company is building up its sales team in anticipation of approval and should be ready to hit the ground running in the second quarter if all goes well.
Spark Therapeutics: The eyes have it
Spark Therapeutics' share price has more than doubled over the last year. Much of the excitement for Spark has stemmed from its lead candidate,voretigene neparvovec (VN), which targetstreatment of inherited retinal disease (IRD) caused by mutations in theRPE65gene.
The biotech has already initiated a rolling submission of a Biologics License Application BLA) forvoretigene neparvovec. Spark expects this submission to be completed early this year with a European regulatory filing to follow.
Chances of U.S. approval appear to be pretty good. Phase 3 results for VN were positive. If approved, the drug would be the first therapy for IRD to demonstrate gains in functional vision that are consistent and durable.
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