GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) shares were falling 2% yesterday after the biotech company handed over its third-fiscal quarter print for the year, with the stock continuing to dash another 3% after the bell.
Though investor sentiment seems a bit skittish on back of the firm’s financial turn-out, Cantor analyst Elemer Piros sees no reason for it, angling for even better chances of approval for epilepsy drug Epidiolex by the third fiscal quarter of next year.
The firm intends to submit a New Drug Application (NDA) by October on rolling basis with eyes on filing a single European Union (EU) filing in both Lennox-Gastaut syndrome (LGS) as well as Dravet syndrome.
On the heels of fiscal quarterly earnings, the analyst reiterates an Overweight rating on GWPH with a $208 price target, which represents an 80% increase from where the shares last closed. (To watch Piros’ track record, click here)
Piros recognizes GW Pharmaceuticals is busy making strides, noting, “[…] progress with its regulatory submissions for Epidiolex and its pre-commercialization activities […] Given the greater visibility into a potential approval, we have adjusted our model to account for a potential approval in the U.S. in F3Q18 and model meaningful revenues beginning in F2019.”
Looking ahead to December’s American Epilepsy Society (AES) meeting, the analyst anticipates “meaningful” Phase 3 data read-outs further bolstering the safety and efficacy profile for the epilepsy drug, adding, “At the AES meeting, we expect data from pooled efficacy and safety of Epidiolex in patients on and off clobazam, as well as individual investigator posters analyzing data of patients on and off clobazam.”
Overall, “Management believes that Epidiolex’s NDA will achieve priority review status with a June 2018 PDUFA timeline. Currently, management believes there is a equal chance for an advisory committee as lack of one. As a reminder, Epidiolex also holds rare pediatric designation, which could earn a rare pediatric voucher upon approval of the drug. Following the U.S. submission, we expect the EU filing to following shortly,” concludes Piros.
Anticipating a PDUFA date will be set for June 2018, the analyst tweaks his model to factor in revenues come 2019 with a net present value for Epidiolex shifted ahead to 2018. Piros expects the epilepsy drug will bring in $131 million for the firm by the fourth fiscal quarter of 2018.
TipRanks analytics indicate GWPH as a Strong Buy. Based on 5 analysts polled by TipRanks in the last 3 months, all 5 rate a Buy on GW Pharmaceuticals stock. The 12-month average price target stands at $164.00, marking a 42% increase from where the stock is currently trading.