Pluristem Therapeutics Inc. (NASDAQ:PSTI) continues to edge higher in the market at the back of positive news on ongoing clinical trials. Reports that the company has entered into an agreement with global drug development services company (CRO) continue to bolster the stock’s sentiments on the street. The news comes on the company announcing it was in the process of initiating Phase 1 trial on its lead drug PLX-R18. News that Gilead Sciences, Inc.(NASDAQ:GILD) has also obtained FDA approval for its Hepatitis C drug Epclusa further affirms how companies are betting big on the future, with clinical trials.
PLX-R18 Big Bet
Given the recent momentum, Pluristem could trade higher going forward on positive news of its two crucial clinical trials. The company is currently carrying out trials in PLX-R18, a drug designed to treat patients who are struggling with insufficient hematopoietic recovery on undergoing hematopoietic cell transplantation. It has also reported positive data from pre-clinical studies on the use of PLX-PAD cells on the treatment of Duchenne muscular dystrophy.
Investors are cautiously awaiting the outcome of ongoing trials on PLX-R18 given its potential impact on the treatment of a wide array of diseases. Treatment of blood cancers, as well as radiation therapy-related blood disease, is some of the notable areas that Pluristem is targeting with the ongoing trials. The trial first received approval by the FDA early in the year with the company planning to begin patient’s enrollment soon.
Pre-clinical studies have already shown how effective PRX-R18 can be on the generation of specific proteins that aid in the regeneration of bone marrow. Initial data has also shown that the drug can help in the production of normal amounts of all the three blood types.
Positive Duchenne Treatment Trial Results
Adding to the positive PRX-R18 new, Pluristem has also reported positive Phase II clinical trial on PLX-PAD, an upcoming treatment for muscle injury. The studies were conducted on children with Duchenne in conjunction with Association Duchenne Israel (ADI). The neuromuscular disorder affects one in 3,500 boys causing progressive muscle weakness that can lead to severe disability and even death.
Buoyed by the positive result ADI, CEO, Hila Krupsky, says PLX-PAD cells could somehow be viewed as a breakthrough therapy. Pluristem says focus now shifts to further studying the cells, in an effort to develop a treatment for the fatal condition.
Gilead’s Turnaround
As Pluristem moves forward with clinical trials, Gilead Sciences, Inc. (NASDAQ:GILD) already has on its hands another multi-billion drug that should help bolster its earnings going forward. Epclusa the new 12-week treatment covers all six hepatitis C virus genotypes.
The drug provides Gilead a much-needed shield given that it’s two other HCV drugs, Harvoni and Sovaldi are under immense pressure on the uptick of competition from Merck and AbbVie. The company is now on course to recover its pricing power on HCV, given that Epclusa offers superior benefits to other treatments in the market.
Should the drug maker succeed in recovering its pricing power, it should be able to recover its status as a growth company its stock having fallen drastically in the recent past over waning investors’ confidence.
Bottom Line
FDA approval of Epclusa could act as a turning point for Gilead Sciences, Inc. (NASDAQ:GILD)’s waning share price on the company succeeding in convincing payers the drug is worth every dollar. Pluristem Therapeutics Inc. (NASDAQ:PSTI), on the other hand, needs to move with speed and conclude the upcoming trials if it is to bolster its sentiments on the street.
