Aug. 9 Quick Takes: With COPD results, Verona eyes path to submission 

Verona Pharma plc (NASDAQ:VRNA) said nebulized PDE3/PDE4 inhibitor ensifentrine significantly improved forced expiratory volume in one second compared with placebo, meeting the primary endpoint in the Phase III ENHANCE-2 trial to treat chronic obstructive pulmonary disease. Data from another Phase III trial, ENHANCE-1, are due by year-end; an NDA submission would follow in 1H23. Verona’s ADRs climbed $3.08 (44%) to $10.03, driving its market cap to about $610 million.

Reata Pharmaceuticals Inc. (NASDAQ:RETA) has a new PDUFA date of Feb. 28, 2023 for omaveloxolone to treat Friedreich’s ataxia. The company said FDA will require an additional three months to review newly submitted analyses of an extension study that Reata regards as confirmatory for the pivotal MOXIe Part II study, as well as an analysis of NFE2L2’s relevance to the disease. Reata’s shares dipped 33% on Monday after the company revealed that FDA continued to express concerns at a mid-cycle communication meeting. FDA granted omaveloxolone, an oleanane triterpenoid that activates NFE2L2 and inhibits NF-kB, priority review in the indication; its original PDUFA date was Nov. 30...