You better have all your spring-cleaning out of the way to make room for a slate of clinical trial readouts and FDA decisions coming up soon. Before April’s finished, all of these biopharmaceutical stocks could swoon or soar depending on how upcoming events play out.
|Company (Stock Symbol)||Market Capitalization||Key Asset|
|GW Pharmaceuticals (NASDAQ:GWPH)||$5.1 billion||Epidiolex|
|FibroGen (NASDAQ:FGEN)||$4.8 billion||pamrevlumab|
|Heron Therapeutics (NASDAQ:HRTX)||$2 billion||HTX-011|
|Assembly Biosciences (NASDAQ:ASMB)||$503 million||ABI-H0731|
GW Pharmaceuticals: Expanding Epidiolex
This is the first company to earn FDA approval for a cannabis-derived drug. Epidiolex is a cannabidiol (CBD) tincture that GW Pharmaceuticals launched last year for two treatment-resistant forms of early onset epilepsy.
GW Pharmaceuticals is running a phase 3 trial for patients with uncontrollable seizures caused by tuberous sclerosis complex (TSC). Before the end of April, we’ll know if Epidiolex has a chance to add this third indication, and success could help the stock continue climbing.
The company thinks there are around 35,440 patients eligible for treatment with Epidiolex now. Success with the TSC indication could add another 25,000 patients to its list of potential customers and give the stock a huge boost in the process.
FibroGen: Preventing scars
This company’s anemia treatment, roxadustat, recently earned approval in China for the treatment of patients with kidney-disease-associated anemia. FibroGen will probably submit an application for the same indication in the U.S. in the third quarter, and any day now the company should let us see some data from a second program called pamrevlumab.
FibroGen is expected to announce interim results from a phase 2 trial with pamrevlumab as a treatment for non-ambulatory Duchenne muscular dystrophy (DMD) patients. This experimental injection appears to halt scar tissue formation, also known as fibrosis, in some important places.
Respiratory and cardiac problems are the main cause of mortality among DMD patients. With this in mind, reducing fibrosis that stiffens the heart and lungs should provide a significant survival benefit. Evidence that pamrevlumab works as expected would…
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