PDUFA Date Coming Up for U.K. Biopharma
Research Report

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 US$35 per share target price on the London, England-based pharmaceutical firm, at the time of the research report was trading at about US$16.90 per share, noted Nash.

From that 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 US$1,400−4,000 per month, but the analyst wrote that 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 approval should not affect their plan and strategy for commercializing ensifentrine.

Nash also pointed out in his report that Verona ended 2023 with US$271.8 million ($271.8M) in cash and cash equivalents. This was more than its US$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 the maintenance treatment of COPD.

Afterward, Verona may commence 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.

Important Disclosures:

1. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Verona Pharma Plc.
2. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
3.  This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
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