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ARTICLE | Regulation

Dec. 20 Quick Takes: Verona lining up COPD submission after second Phase III readout

Plus: F-star takeout remains in CFIUS limbo and updates from Seagen, Astellas, Merck, Catalyst, Eisai and more

December 20, 2022 11:03 PM UTC

Shares of Verona Pharma plc (NASDAQ:VRNA) surged 38% to $18.59 Tuesday after the company said nebulized ensifentrine met the primary endpoint in the Phase III ENHANCE-1 trial to treat chronic obstructive pulmonary disease, setting up the company to submit an NDA next half. The selective dual inhibitor of PDE-3 and PDE-4 had already met the primary endpoint in the Phase III ENHANCE-2 trial. Since its close at $6.95 on Aug. 8, before Verona announced the ENHANCE-2 results, Verona has gained 167%.

invoX Pharma Ltd.’s acquisition of F-star Therapeutics Inc. (NASDAQ:FSTX) has been delayed a third time after the Committee on Foreign Investment in the United States (CFIUS) told the companies that its review of the deal is continuing for an additional 45 days or more. According to an F-star regulatory filing, CFIUS has identified national security risks arising from the deal and is considering whether “mitigation measures could adequately resolve the identified risks.” An initial delay was announced in September, followed by a second announced Nov. 1. The deal has cleared foreign investment regulations in the U.K., where invoX, a Sino Biopharmaceutical Ltd. (HKEX:1177) unit, is based...

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