Hims & Hers jumps as status report says patients unable to obtain branded GLP-1s

A joint status report that was filed in the U.S. District Court for the Northern District of Texas states in part: “To assist FDA in its reevaluation of the challenged decision, Plaintiffs have continued to monitor market conditions for Tirzepatide and that they, their members, and other interested persons have provided the agency with evidence that the drug remains in shortage. Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist products, including specifically branded Tirzepatide products. Pharmacy distributors continue to list branded Tirzepatide products as out-of-stock or available in only limited quantities. Meanwhile, production of compounded Tirzepatide products by members of Plaintiff Outsourcing Facilities Association has remained steady or grown, reflecting still more market demand and medical need that is unable to be met by branded Tirzepatide products… The parties believe that this case should continue to be stayed pursuant to the October 11, 2024 Order, and they intend, absent alternative direction from the Court, to file a further joint status report by the earlier of December 19, 2024, or within seven days of FDA’s decision on remand.” This filing comes following a lawsuit that the Outsourcing Facilities Association filed, stating that the FDA made a “reckless and arbitrary decision,” via an unlawful process, to deprive patients of type 2 diabetes and obesity medications. BTIG previously said the demand has led to at least some temporary relief for compounding pharmacies, and will benefit both LifeMD (LFMD) and Hims & Hers (HIMS). Eli Lilly (LLY) is the maker of branded tirzepatide injections for weight loss. In late day trading, shares of Hims & Hers are up about 8%.