GW Pharmaceuticals (NASDAQ:GWPH) has Wall Street buzzing in an exciting week that has led to an FDA AdCom giving a unanimous 13-to-0 vote in favor of lead cannabis-based epilepsy asset Epidiolex’s approval. There still lies a PDUFA date with destiny come June 27th for indications of LennoxGastaut syndrome (LGS) and Dravet syndrome (DS) and an EMA action date likely for the first quarter of 2019.
In reaction, Cantor analyst Elemer Piros is out with bullish praise, reiterating an Overweight rating on GWPH stock while bumping up the price target from $192 to $205, which implies a 52% upside from current levels. (To watch Piros’ track record, click here)
“Given the positive AdCom decision in addition to the positive results seen in three pivotal trials in two distinct indications (which led to applause from the audience after hearing patient perspectives), we have increased our confidence in Epidiolex’s approval in the U.S. to 100% probability of success (from 90% previously). We predict that the drug will be approved imminently, much before the PDUFA date,” cheers Piros.
The analyst asserts on a confident note that this drug shows “compelling” efficacy between trial results to patient perspectives, where one patient suffering from seizures went from up to 100 each day to presently no seizures anymore for more than two years now.
Bottom line looks stellar for the drug maker from where Piros is standing: “The overall tone of the meeting was positive, with the FDA having identified no obstacles to approval. A majority of questions focused on drug-drug interactions, manufacturing and adverse events. On safety, the FDA highlighted the limited association with use of CBD and ALT elevations, which we believe could potentially lead to a very manageable but not unexpected Boxed Warning label. Importantly, the Committee highlighted that the drug led to no cases of Hy’s Law and showed limited abuse potential.”
In anticipation of Epidiolex’s prospective launch come next year, Piros concludes ascribing a 100% probability of success compared to a prior probability of 90% in the U.S. The analyst looks for $36,000 as a launch price for the drug in the U.S. and $24,000 in the EU, with sales that could potentially circle $136 million next year.
TipRanks exhibits this drug maker as a Strong Buy on Wall Street. All 3 analysts polled in the last 3 months rate a Buy on GWPH stock. With a healthy return potential of 29%, the stock’s consensus target price stands at $175.67.