BofA notes that Judge Mark Pittman last night ruled in favor of the Food and Drug Administration, denying the Outsourcing Facilities Association’s motion for preliminary injunction in the case related to the shortage decision for Eli Lilly’s (LLY) weight loss drug tirzepatide. Based on the FDA’s updated policies on the grace period for compounding tirzepatide, state-licensed pharmacies under 503A must discontinue compounding tirzepatide as of March 5, while outsourcing facilities under 503B have until March 19, the analyst noted. The firm calls the decision “a direct negative for 503B compounding pharmacies of tirzepatide if the order stands” and an “indirect negative” for Hims & Hers (HIMS), noting that while Hims does not compound tirzepatide, if a similar decision is applied to Novo’s (NVO) semaglutide, 503B pharmacies would be unable to compound the drug following the end of the grace period in May. BofA maintains an Underperform rating and $21 price target on Hims shares.
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