3 Biotechs With Key Decisions Pending in the Next 18 Months

3 Biotechs With Key Decisions Pending in the Next 18 Months September 27, 2016
By Mark Terry, BioSpace.com Breaking News Staff

As hockey great Wayne Gretzky once said, “You miss 100 percent of the shots you don’t take.” Cheryl Swanson, writing for The Motley Fool, takes a look at three biotech companies who have taken big shots and will be reporting on their success in the next six to 18 months. Let’s take a look.

Coherus Biosciences

Coherus Biosciences (CHRIS), headquartered in San Francisco, submitted a biologics license application (BLA) for its biosimilar of Amgen ’s Neulasta in August. If approved, it has a shot at $1 billion in annual sales. Coherus also recently provided data on a Phase III trial of another biosimilar, CHS-1420, this one for AbbVie ’s Humira in psoriasis patients. The company is expecting its BLA for CHS-1420 to be accepted by the U.S. Food and Drug Administration (FDA) in the first half of 2016.

Coherus also announced oday that Shire had terminated its collaboration deal for CHS-0214 after Shire performed a portfolio evaluation in the wake of its Baxalta acquisition earlier this year. This resulted in Coherus regaining rights to the drug in several key geographic regions.

Swanson writes, “The company has other biosimilars further down its pipeline, including copycats of biologics Avastin and Lucentis. While I don’t currently own Coherus, I believe it could achieve some of the earliest biosimilar launches for blockbusters Neulasta and Humira, so I may buy a small position soon.”

Coherus stock is currently trading for $29.99.

Lexicon Pharmaceuticals

The Woodlands, Texas-based Lexicon Pharmaceuticals recently reported positive data from a late-stage trial of sotagliflozin, which is backed by Paris-based Sanofi . Swanson writes, “The oral diabetes treatment is a first-in-class combination of an SGLT1 inhibitor with an SGLT2 inhibitor. Peak sales could exceed $2 billion, assuming the drug succeeds in Type 2 diabetes as well as Type 1.”

The company plans to start Phase III trials in Type 2 diabetes by the end of the year. And it is expecting data from a pivotal Phase III trial in Type 1 diabetes by the end of the year. It also has a drug, telotristat etiprate, under review by the FDA for carcinoid syndrome, with a decision expected in February 2017.

Lexicon Pharmaceuticals is currently trading for $18.30.

Amicus Therapeutics

Swanson’s third pick is Amicus Therapeutics , which is expected to have actual product revenue for this year’s third quarter. Its drug, migalastat, for rare Fabry disease, was approved in the EU and is making headway. In addition, the drug, which is taken orally versus standard treatment as an infusion, is expecting information by the FDA by the end of this year.

Amicus also is expecting Phase III data in the first half of next year for a drug to treat Epidermolysis Bullosa, as well as some preclinical work being done on a drug for Pompe Disease.

Amicus is currently trading for $7.63.

Swanson notes that, “for investors who don’t mind high risk, these three biotechs have enough big-time upside in their pipelines to make them intriguing candidates for your watchlist.”

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