Amylyx Pharmaceuticals Inc.’s closing of the deal to acquire GLP-1 receptor antagonist avexitide for $35.1 million from Eiger Biopharmaceuticals Inc. brought added attention to the phase III-ready, first-in-class compound. Avexitide has been tested in five trials for post-bariatric hypoglycemia (PBH) and has also been investigated in congenital hyperinsulinism (HI) – both characterized by hyperinsulinemic hypoglycemia. The U.S. FDA has granted avexitide breakthrough therapy designation for the disorders, as well as rare pediatric disease status in congenital HI, and orphan drug designation for hyperinsulinemic hypoglycemia, which includes HI as well as PBH. Shares of Cambridge, Mass.-based Amylyx (NASDAQ:AMLX) were trading July 10 at $1.93, up 28 cents, or 17%.

US FTC’s noncompete rule on shaky ground

In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning most noncompete employment clauses is on shaky ground. The first tremor hit last week when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority. The order in Ryan LLC v. FTC is among the first to cite Loper Bright, which was handed down just a few days earlier. For now, the injunction provides relief only to the plaintiffs in Ryan.

BIX Korea 2024: Promise of mRNA technology for cell and gene therapy

The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies. “The promise of mRNA therapeutics is that it can teach the body to make its own medicine,” Richard D. Braatz, professor of chemical engineering at the Massachusetts Institute of Technology, told audience members at the Bioplus Interphex Korea (BIX) 2024 conference in Seoul, South Korea July 10. “Instead of delivering medicine to the body, mRNA therapeutics deliver ‘instructions’ that can tell the body how to [self-]make therapies,” Braatz said.

South Africa drops anticompetition complaint against J&J

In light of a 40% price cut and a commitment to not enforce a patent protecting a tuberculosis (TB) drug in 134 low- and middle-income countries, South Africa’s Competition Commission decided not to prosecute a complaint accusing Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceutica (Pty) Ltd., of anticompetitive conduct. The complaint was lodged after the companies filed a secondary patent in South Africa last year for Sirturo (bedaquiline fumarate), which effectively would have blocked generic versions of the TB drug until at least 2027.

Apeiron exits through M&A, as Ligand gains Qarziba royalties

Ligand Pharmaceuticals Inc. is adding one more income stream to its portfolio, with the $100 million acquisition of Apeiron Biologics AG, owner of royalty rights to Qarziba, a treatment for high risk neuroblastoma that is currently marketed in 35 countries and is en route to approval in the U.S. In addition to the up-front all-cash payment, there is a further, unspecified amount to come in commercial and regulatory milestones, including $28 million if Qarziba (dinutuximab beta) royalties exceed certain thresholds by 2030 and 2034. At the same time, Jupiter, Fla-based Ligand is investing up to $4 million into Invios AG, a spin-out Apeiron formed to split its three early stage immuno-oncology programs from the parent company.

Also in the news

Abbvie, Aeon, Arcus, Arcutis, Biocryst, Celon, Discgenics, Elevar, Everyone Medicines, Genentech, Ionctura, Isomab, Kymera, Mesoblast, Mitsubishi Tanabe, Moderna, Obsidian, Opthea, Oxurion, Pathios, Quell, Redhill, Soligenix, Taiho, Tharimmune, Theralase, Tonix, Uniqure, Zevra