Verona Pharma Plc (VRNA:NASDAQ; VRP:LON) will learn, on its June 26 PDUFA date, whether the U.S. Food and Drug Administration (FDA) will approve the biopharma's nebulized ensifentrine for maintenance treatment of chronic obstructive pulmonary disease (COPD), reported Canaccord Genuity analyst Edward Nash in a March 7 research note.
"Given the positive results of the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program as well as the favorable safety profile of ensifentrine, we have high confidence that the drug will receive FDA approval in June," Nash wrote.
Ensifentrine is a first-in-class, inhaled, dual inhibitor of the phosphodiesterase 3 and 4 enzymes.
107% potential return
Canaccord has a $35 per share target price on the London, England-based pharmaceutical firm, now trading at about $16.90 per share, noted Nash.
From the current price, the return to target suggests a 107% gain for investors.
Verona remains a Buy.
Commercialization plan in place
The biopharma has developed a plan for commercially launching ensifentrine, assuming the FDA approves it, and is preparing to get it on the market, Nash reported.
In its launch plan, Verona included an estimated price range for ensifentrine of $1,400−4,000 per month, but the analyst wrote, it will deliver specific prices at the PDUFA meeting.
The FDA may also approve a label expansion of a competing drug, Dupixent, to include COPD on the PDUFA date set for it, June 27, Nash noted. However, Verona management indicated that such an approval should not affect their plan and strategy for commercializing ensifentrine.
Nash also pointed out in his report that Verona ended 2023 with $271.8 million ($271.8M) in cash and cash equivalents. This was more than its $257.4M balance at the end of Q3/23.
What to watch for
Beyond the upcoming PDUFA date in June, Verona has additional events that could boost its share price.
For instance, in H2/24, the company expects to submit an investigational new drug application for a fixed dose combination formulation of ensifentrine plus the long-acting muscarinic antagonist, glycopyrrolate, for maintenance treatment of COPD.
After, Verona may commence start a Phase 2 trial evaluating this combination therapy in this indication.
Also planned for about the same time is the start of a Phase 2 trial of monotherapy ensifentrine in non-cystic fibrosis bronchiectasis.
| Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. | Subscribe |
