AVDL inventory at eight-month excessive as FTC feedback elevate prospects for lead drug (NASDAQ:AVDL)

Eire-based biopharma Avadel Prescription drugs (NASDAQ:AVDL) added ~26% on Friday to achieve the best stage since March, as Needham famous that latest feedback made by the Federal Commerce Fee (FTC) might result in imminent FDA approval for its lead asset Lumryz.

FDA has already granted tentative approval for Lumryz to deal with extreme daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

Nevertheless, the corporate has but to obtain the ultimate approval amid a patent dispute with Jazz Pharma (NASDAQ:JAZZ) which affords the rival remedy Xyrem. The difficulty pertains to U.S. patent No. 8731963 (REMS Patent), listed within the FDA’s Orange E book.

In an amicus temporary on Thursday, the FTC argued that patents corresponding to ‘963 associated to REMS distribution techniques shouldn’t block generic or different competitors.

In response, Needham analyst Ami Fadia famous that FTC’s view signifies that the ‘963 patent “shouldn’t be within the Orange E book, which might take away the ultimate hurdle to Lumryz getting FDA approval that might in any other case solely get cleared by patent expiry on June 17, 2023.”

Searching for Alpha contributor Bret Jensen explains how traders ought to tackle the regulatory uncertainty as Avadel (AVDL) seeks full approval for Lumryz.